Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-01 @ 10:54 PM
Study NCT ID:
NCT00927368
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2009-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of 3 Techniques for Ultrasound-guided Femoral Nerve Catheter Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'johnsor13@ccf.org', 'phone': '216-444-9950', 'title': 'Roberta Johnson', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ultrasound Guidance Alone', 'description': 'The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.\n\nultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.', 'otherNumAtRisk': 147, 'otherNumAffected': 0, 'seriousNumAtRisk': 147, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ultrasound Guidance Needle Stimulation', 'description': 'For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation\n\nultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation.', 'otherNumAtRisk': 152, 'otherNumAffected': 0, 'seriousNumAtRisk': 152, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Ultrasound Guidance+Catheter Stimulation', 'description': 'For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.', 'otherNumAtRisk': 138, 'otherNumAffected': 0, 'seriousNumAtRisk': 138, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time Weighted Average Verbal Response Scale Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Guidance Alone', 'description': 'The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.\n\nultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.'}, {'id': 'OG001', 'title': 'Ultrasound Guidance Needle Stimulation', 'description': 'For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation\n\nultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation.'}, {'id': 'OG002', 'title': 'Ultrasound Guidance+Catheter Stimulation', 'description': 'For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.52', 'spread': '1.62', 'groupId': 'OG000'}, {'value': '3.24', 'spread': '1.55', 'groupId': 'OG001'}, {'value': '3.40', 'spread': '1.47', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '0.29', 'pValueComment': 'Significance criterion of 0.00694 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.', 'groupDescription': 'The primary analysis for pain was a linear regression model comparing stimulating needle to stimulating catheter on the mean time-weighted average pain score for a patient in the first 48 hours.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean stimulating catheter is greater than 0.5 points).'}, {'pValue': '0.03', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.61', 'pValueComment': 'Significance criterion of 0.01735 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.', 'groupDescription': 'The primary analysis for pain was a linear regression model comparing stimulating catheter to stimulating needle on the mean time-weighted average pain score for a patient in the first 48 hours.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean stimulating needle is greater than 0.5 points).'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.33', 'pValueComment': 'Significance criterion of 0.01041 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.', 'groupDescription': 'The primary analysis for pain was a linear regression model comparing stimulating catheter to ultrasound alone on the mean time-weighted average pain score for a patient in the first 48 hours.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean catheter minus mean ultrasound alone is greater than 0.5 points).'}, {'pValue': '0.02', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.57', 'pValueComment': 'Significance criterion of 0.01388 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.', 'groupDescription': 'The primary analysis for pain was a linear regression model comparing ultrasound alone to stimulating catheter on the mean time-weighted average pain score for a patient in the first 48 hours.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean catheter is greater than 0.5 points).'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '0.16', 'pValueComment': 'Significance criterion of 0.00347 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.', 'groupDescription': 'The primary analysis for pain was a linear regression model comparing stimulating needle to ultrasound alone on the mean time-weighted average pain score for a patient in the first 48 hours.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean ultrasound alone is greater than 0.5 points).'}, {'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.28', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.72', 'pValueComment': 'Significance criterion of 0.02082 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.', 'groupDescription': 'The primary analysis for pain was a linear regression model comparing ultrasound alone to stimulating needle on the mean time-weighted average pain score for a patient in the first 48 hours.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating needle is greater than 0.5 points).'}], 'paramType': 'MEAN', 'timeFrame': '48 hours after surgery', 'description': 'Time weighted average of verbal response scale (VRS) pain score on a scale from 0 (no pain) to 10 (worst pain imaginable).\n\nVerbal Response Scale (VRS) pain scores after surgery - which ranged from 0 (no pain) to 10 (maximum intolerable pain) - were assessed every 30 minutes in the recovery area and every 4 hours thereafter up to 48 hours postoperatively. These individual measurements were averaged for each patient using a time-weighted formula. (For a given patient, the observed VRS pain score profile as a function of time was linearly interpolated and integrated using the trapezoidal rule; then, the time-weighted average was calculated as the value of this integral divided by the total monitoring time of 48 hours.).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Opioid Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Guidance Alone', 'description': 'The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.\n\nultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.'}, {'id': 'OG001', 'title': 'Ultrasound Guidance Needle Stimulation', 'description': 'For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation\n\nultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation.'}, {'id': 'OG002', 'title': 'Ultrasound Guidance+Catheter Stimulation', 'description': 'For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '81'}, {'value': '58', 'groupId': 'OG001', 'lowerLimit': '39', 'upperLimit': '80'}, {'value': '55', 'groupId': 'OG002', 'lowerLimit': '38', 'upperLimit': '85'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5', 'ciLowerLimit': '-17', 'ciUpperLimit': '34', 'pValueComment': 'Significance criterion of 0.02082 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.', 'groupDescription': 'The primary analysis for opioid was a linear regression model comparing stimulating catheter to stimulating needle on the log of cumulative opioid consumption score for a patient in the first 48 hours.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean stimulating needle is greater than 0.5 points).'}, {'pValue': '0.002', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5', 'ciLowerLimit': '-25', 'ciUpperLimit': '21', 'pValueComment': 'Significance criterion of 0.00347 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.', 'groupDescription': 'The primary analysis for opioid was a linear regression model comparing stimulating needle to stimulating catheter on the log of cumulative opioid consumption score for a patient in the first 48 hours.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean stimulating catheter is greater than 0.5 points).'}, {'pValue': '0.03', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3', 'ciLowerLimit': '-25', 'ciUpperLimit': '21', 'pValueComment': 'Significance criterion of 0.01735 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.', 'groupDescription': 'The primary analysis for opioid was a linear regression model comparing stimulating catheter to ultrasound alone on the log of cumulative opioid consumption score for a patient in the first 48 hours.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean ultrasound alone is greater than 0.5 points).'}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3', 'ciLowerLimit': '-24', 'ciUpperLimit': '23', 'pValueComment': 'Significance criterion of 0.00694 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.', 'groupDescription': 'The primary analysis for opioid was a linear regression model comparing ultrasound alone to stimulating catheter on the log of cumulative opioid consumption score for a patient in the first 48 hours.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating catheter is greater than 0.5 points).'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2', 'ciLowerLimit': '-22', 'ciUpperLimit': '25', 'pValueComment': 'Significance criterion of 0.01041 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.', 'groupDescription': 'The primary analysis for opioid was a linear regression model comparing stimulating needle to ultrasound alone on the log of cumulative opioid consumption score for a patient in the first 48 hours.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean ultrasound alone is greater than 0.5 points).'}, {'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2', 'ciLowerLimit': '-20', 'ciUpperLimit': '29', 'pValueComment': 'Significance criterion of 0.01388 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons.', 'groupDescription': 'The primary analysis for opioid was a linear regression model comparing ultrasound alone to stimulating needle on the log of cumulative opioid consumption score for a patient in the first 48 hours.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating needle is greater than 0.5 points).'}], 'paramType': 'MEDIAN', 'timeFrame': '48 hours after surgery', 'description': 'cumulative opioid consumption, where all opioids were converted to IV morphine equivalents', 'unitOfMeasure': 'mg morphine equivalents', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Block Performance Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Guidance Alone', 'description': 'The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.\n\nultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.'}, {'id': 'OG001', 'title': 'Ultrasound Guidance Needle Stimulation', 'description': 'For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation\n\nultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation.'}, {'id': 'OG002', 'title': 'Ultrasound Guidance+Catheter Stimulation', 'description': 'For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.'}], 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000', 'lowerLimit': '85', 'upperLimit': '135'}, {'value': '150', 'groupId': 'OG001', 'lowerLimit': '126', 'upperLimit': '175'}, {'value': '177', 'groupId': 'OG002', 'lowerLimit': '151', 'upperLimit': '202'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG001', 'OG002'], 'groupDescription': 'Stimulating needle versus stimulating catheter.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40', 'ciLowerLimit': '6', 'ciUpperLimit': '75', 'groupDescription': 'Stimulating needle versus ultrasound guidance alone', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '67', 'ciLowerLimit': '31', 'ciUpperLimit': '102', 'groupDescription': 'Stimulating catheter versus ultrasound guidance alone', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'time elapsed from beginning the block to catheter placement', 'description': 'Block performance time, defined as the time from block start until catheter placement.', 'unitOfMeasure': 'seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incremental Cost of Femoral Nerve Blocks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '143', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ultrasound Guidance Alone', 'description': 'The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.\n\nultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.'}, {'id': 'OG001', 'title': 'Ultrasound Guidance Needle Stimulation', 'description': 'For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation\n\nultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation.'}, {'id': 'OG002', 'title': 'Ultrasound Guidance+Catheter Stimulation', 'description': 'For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'spread': '0', 'groupId': 'OG000'}, {'value': '36', 'spread': '0', 'groupId': 'OG001'}, {'value': '50', 'spread': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'incremental cost, measured in dollars', 'ciNumSides': 'TWO_SIDED', 'paramValue': '14', 'estimateComment': 'Incremental cost (additional cost of stimulating needle compared to ultrasound alone).', 'groupDescription': 'We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'incremental cost, measured in dollars', 'ciNumSides': 'TWO_SIDED', 'paramValue': '36', 'estimateComment': 'We estimated incremental cost, or additional cost of stimulating needle + catheter stimulation to stimulating needle alone.', 'groupDescription': 'We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'incremental cost, measured in dollars', 'ciNumSides': 'TWO_SIDED', 'paramValue': '50', 'estimateComment': 'We calculated incremental cost, or the additional cost of stimulating needle + stimulating catheter to ultrasound alone.', 'groupDescription': 'We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'postoperative period when block is used', 'description': 'The incremental cost between strategies was calculated as the additional cost of one strategy to the next less costly strategy. There was no variance in the price because these prices were contracted with the hospital. The contracted price for a hospital does not change or fluctuate.', 'unitOfMeasure': 'dollars', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ultrasound Guidance Alone', 'description': 'The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.\n\nultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.'}, {'id': 'FG001', 'title': 'Ultrasound Guidance Needle Stimulation', 'description': 'For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation\n\nultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation.'}, {'id': 'FG002', 'title': 'Ultrasound Guidance+Catheter Stimulation', 'description': 'For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '157'}, {'groupId': 'FG002', 'numSubjects': '143'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '152'}, {'groupId': 'FG002', 'numSubjects': '138'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'enrollment in another study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'equipment failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'ineligible post randomization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'cancellation of surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}, {'value': '437', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Ultrasound Guidance Alone', 'description': 'The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.\n\nultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.'}, {'id': 'BG001', 'title': 'Ultrasound Guidance Needle Stimulation', 'description': 'For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation\n\nultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation.'}, {'id': 'BG002', 'title': 'Ultrasound Guidance+Catheter Stimulation', 'description': 'For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '9', 'groupId': 'BG000'}, {'value': '61', 'spread': '13', 'groupId': 'BG001'}, {'value': '63', 'spread': '9', 'groupId': 'BG002'}, {'value': '62', 'spread': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '236', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '201', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 453}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-06', 'studyFirstSubmitDate': '2009-06-24', 'resultsFirstSubmitDate': '2016-06-27', 'studyFirstSubmitQcDate': '2009-06-24', 'lastUpdatePostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-06-27', 'studyFirstPostDateStruct': {'date': '2009-06-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time Weighted Average Verbal Response Scale Pain Score', 'timeFrame': '48 hours after surgery', 'description': 'Time weighted average of verbal response scale (VRS) pain score on a scale from 0 (no pain) to 10 (worst pain imaginable).\n\nVerbal Response Scale (VRS) pain scores after surgery - which ranged from 0 (no pain) to 10 (maximum intolerable pain) - were assessed every 30 minutes in the recovery area and every 4 hours thereafter up to 48 hours postoperatively. These individual measurements were averaged for each patient using a time-weighted formula. (For a given patient, the observed VRS pain score profile as a function of time was linearly interpolated and integrated using the trapezoidal rule; then, the time-weighted average was calculated as the value of this integral divided by the total monitoring time of 48 hours.).'}, {'measure': 'Opioid Consumption', 'timeFrame': '48 hours after surgery', 'description': 'cumulative opioid consumption, where all opioids were converted to IV morphine equivalents'}], 'secondaryOutcomes': [{'measure': 'Block Performance Time', 'timeFrame': 'time elapsed from beginning the block to catheter placement', 'description': 'Block performance time, defined as the time from block start until catheter placement.'}, {'measure': 'Incremental Cost of Femoral Nerve Blocks', 'timeFrame': 'postoperative period when block is used', 'description': 'The incremental cost between strategies was calculated as the additional cost of one strategy to the next less costly strategy. There was no variance in the price because these prices were contracted with the hospital. The contracted price for a hospital does not change or fluctuate.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['TKA', 'total knee replacement'], 'conditions': ['Total Knee Replacement Surgery']}, 'descriptionModule': {'briefSummary': 'This is a randomized study which will compare three femoral nerve catheter insertion techniques. Subjects will be randomized into one of thee groups, Group 1: ultrasound guided femoral nerve catheter using a stimulation needle and stimulating catheter, .Group 2: ultrasound guided femoral nerve catheter using a stimulation needle, but non-stimulating catheter, or Group 3: ultrasound guided femoral nerve block without stimulation.', 'detailedDescription': 'This is a randomized study which will compare three femoral nerve catheter insertion techniques. Subjects will be randomized into one of thee groups, Group 1: ultrasound guided femoral nerve catheter using a stimulation needle and stimulating catheter, .Group 2: ultrasound guided femoral nerve catheter using a stimulation needle, but non-stimulating catheter, or Group 3: ultrasound guided femoral nerve block without stimulation.\n\n* Pain Scores after surgery with be measured using the VAS (Visual Analogue Scale). Subjects will be asked to rate their pain on a scale of 1-10.\n* Block Performance time is the time from starting the block (after prepping and draping) until catheter is placed.\n* Opioid requirements will be measured as the total amount of opioids (converted to morphine sulfate equivalents) used both during surgery, and during the first 48 hours after surgery.\n* Block failure rate will be calculated as the rate of cases that requires repeating the block after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 80 years old at time of surgery.\n* Male or female patients undergoing total knee replacement under either general or neuraxial anesthesia (spinal or epidural). Intraoperative, patients will receive spinal anesthetics with 15 mg bupivacaine and 25mcg of fentanyl intrathecally.\n\nExclusion Criteria:\n\n* Current or recent drug abuse (within past 6 months).\n* Pregnancy.\n* Patient refuses regional analgesia.'}, 'identificationModule': {'nctId': 'NCT00927368', 'briefTitle': 'Comparison of 3 Techniques for Ultrasound-guided Femoral Nerve Catheter Insertion', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Comparison Between Ultrasound Guided Femoral Nerve Block Versus Ultrasound Guided Femoral Nerve Block With the Use of Peripheral Nerve Stimulation for Patients Undergoing Total Knee Replacement.', 'orgStudyIdInfo': {'id': '09-340'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound guidance alone', 'description': 'The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.', 'interventionNames': ['Procedure: ultrasound guidance alone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound guidance needle stimulation', 'description': 'For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation', 'interventionNames': ['Procedure: ultrasound guidance and needle stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound guidance+catheter stimulation', 'description': 'For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.', 'interventionNames': ['Procedure: ultrasound guidance and catheter stimulation']}], 'interventions': [{'name': 'ultrasound guidance alone', 'type': 'PROCEDURE', 'description': 'The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.', 'armGroupLabels': ['Ultrasound guidance alone']}, {'name': 'ultrasound guidance and needle stimulation', 'type': 'PROCEDURE', 'description': 'For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation.', 'armGroupLabels': ['Ultrasound guidance needle stimulation']}, {'name': 'ultrasound guidance and catheter stimulation', 'type': 'PROCEDURE', 'description': 'The Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.', 'armGroupLabels': ['Ultrasound guidance+catheter stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Ehab Farag, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}, {'name': 'Daniel I Sessler, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ehab Farag', 'investigatorAffiliation': 'Outcomes Research Consortium'}}}}