Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-30 @ 12:39 PM
Study NCT ID:
NCT01333956
Status:
COMPLETED
Last Update Posted:
2016-05-18
First Post:
2011-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Pregabalin on Pain After Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yadeauj@hss.edu', 'phone': '212-606-1206', 'title': 'Dr. Jacques YaDeau', 'organization': 'Hospital for Special Surgery'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Patients will receive 0mg of pregabalin\n\nPlacebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '50mg Arm', 'description': 'Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '100mg Arm', 'description': 'Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '150mg Arm', 'description': 'Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Postoperative Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will receive 0mg of pregabalin\n\nPlacebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of post-operative day (POD)14 and one capsule at bedtime POD15, POD16.'}, {'id': 'OG001', 'title': '50mg Arm', 'description': 'Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'OG002', 'title': '100mg Arm', 'description': 'Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'OG003', 'title': '150mg Arm', 'description': 'Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}], 'classes': [{'title': 'POD14 Pain score with flexion', 'categories': [{'measurements': [{'value': '4', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '4.5', 'spread': '2.4', 'groupId': 'OG002'}, {'value': '4.0', 'spread': '2.1', 'groupId': 'OG003'}]}]}, {'title': 'POD14 Pain score with ambulation', 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '1.8', 'groupId': 'OG002'}, {'value': '3.1', 'spread': '1.9', 'groupId': 'OG003'}]}]}, {'title': 'POD14 Pain score at rest', 'categories': [{'measurements': [{'value': '2.9', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '1.8', 'groupId': 'OG002'}, {'value': '2.7', 'spread': '2.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 weeks postoperatively', 'description': 'Pain assessment scale (Numeric Rating Scale) (0=no pain; 10=worst pain imaginable).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid-Related Symptom Distress Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will receive 0mg of pregabalin\n\nPlacebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'OG001', 'title': '50mg Arm', 'description': 'Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'OG002', 'title': '100mg Arm', 'description': 'Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'OG003', 'title': '150mg Arm', 'description': 'Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}], 'classes': [{'title': 'ORSDS POD1', 'categories': [{'measurements': [{'value': '.4', 'groupId': 'OG000', 'lowerLimit': '.2', 'upperLimit': '.7'}, {'value': '.4', 'groupId': 'OG001', 'lowerLimit': '.2', 'upperLimit': '.6'}, {'value': '.5', 'groupId': 'OG002', 'lowerLimit': '.2', 'upperLimit': '.7'}, {'value': '.4', 'groupId': 'OG003', 'lowerLimit': '.2', 'upperLimit': '.8'}]}]}, {'title': 'ORSDS POD14', 'categories': [{'measurements': [{'value': '.3', 'groupId': 'OG000', 'lowerLimit': '.1', 'upperLimit': '.5'}, {'value': '.3', 'groupId': 'OG001', 'lowerLimit': '.1', 'upperLimit': '.5'}, {'value': '.3', 'groupId': 'OG002', 'lowerLimit': '.1', 'upperLimit': '.5'}, {'value': '.3', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 weeks postoperatively', 'description': 'Opioid-Related Symptom Distress score (ORSDS) measured at POD1 and POD14. The ORSDS is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS is the average of 12 symptom-specific scores. (0=low; 4=high).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-assessed Sedation and Confusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will receive 0mg of pregabalin\n\nPlacebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'OG001', 'title': '50mg Arm', 'description': 'Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'OG002', 'title': '100mg Arm', 'description': 'Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'OG003', 'title': '150mg Arm', 'description': 'Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}], 'classes': [{'title': 'Drowsiness POD1 [ORSDS]', 'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000'}, {'value': '37.9', 'groupId': 'OG001'}, {'value': '55.2', 'groupId': 'OG002'}, {'value': '58.6', 'groupId': 'OG003'}]}]}, {'title': 'Nausea POD1 [ORSDS]', 'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000'}, {'value': '41.4', 'groupId': 'OG001'}, {'value': '44.8', 'groupId': 'OG002'}, {'value': '31.0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day postoperatively', 'description': 'Self-assessed sedation and confusion (POD1). Confusion Assessment Method (CAM score) (pre-operative and on POD1)', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Numeric Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will receive 0mg of pregabalin\n\nPlacebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'OG001', 'title': '50mg Arm', 'description': 'Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'OG002', 'title': '100mg Arm', 'description': 'Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'OG003', 'title': '150mg Arm', 'description': 'Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}], 'classes': [{'title': 'Preop NRS Pain Score with Flexion', 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '6'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '6.5'}, {'value': '3.9', 'groupId': 'OG002', 'lowerLimit': '2.8', 'upperLimit': '5.1'}, {'value': '5.7', 'groupId': 'OG003', 'lowerLimit': '4.4', 'upperLimit': '7'}]}]}, {'title': 'POD1 NRS Pain Score with Flexion', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '4'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '2.7', 'groupId': 'OG002', 'lowerLimit': '1.8', 'upperLimit': '3.3'}, {'value': '2.5', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '3.3'}]}]}, {'title': 'POD3 NRS Pain Score with Flexion', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '4.8'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '5.2'}, {'value': '3.6', 'groupId': 'OG002', 'lowerLimit': '2.8', 'upperLimit': '4.7'}, {'value': '4.3', 'groupId': 'OG003', 'lowerLimit': '3.3', 'upperLimit': '5.3'}]}]}, {'title': 'POD14 NRS Pain Score with Flexion', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '5'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '5.6'}, {'value': '4.5', 'groupId': 'OG002', 'lowerLimit': '3.7', 'upperLimit': '5.4'}, {'value': '4.2', 'groupId': 'OG003', 'lowerLimit': '3.2', 'upperLimit': '5'}]}]}, {'title': '3 months NRS Pain Score with Flexion', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '.9', 'upperLimit': '2.7'}, {'value': '1.7', 'groupId': 'OG002', 'lowerLimit': '.7', 'upperLimit': '1.8'}, {'value': '1.8', 'groupId': 'OG003', 'lowerLimit': '.9', 'upperLimit': '2.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'NRS Pain (pre-operative, POD1, POD3, 2 weeks, 3 months, at orthopedic visits). Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months)', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neuropathic Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will receive 0mg of pregabalin\n\nPlacebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'OG001', 'title': '50mg Arm', 'description': 'Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'OG002', 'title': '100mg Arm', 'description': 'Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'OG003', 'title': '150mg Arm', 'description': 'Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3 months', 'description': 'Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months). Scale of 0 to 24. Higher values represent worse outcomes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will receive 0mg of pregabalin\n\nPlacebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'OG001', 'title': '50mg Arm', 'description': 'Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'OG002', 'title': '100mg Arm', 'description': 'Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'OG003', 'title': '150mg Arm', 'description': 'Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}], 'classes': [{'title': 'Preop Total Opioid Use (mg)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '22'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '20'}, {'value': '17', 'groupId': 'OG002', 'lowerLimit': '15', 'upperLimit': '19'}, {'value': '18', 'groupId': 'OG003', 'lowerLimit': '16', 'upperLimit': '20'}]}]}, {'title': 'POD 1 Total Opioid Use (mg)', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '63'}, {'value': '46', 'groupId': 'OG001', 'lowerLimit': '35', 'upperLimit': '57'}, {'value': '57', 'groupId': 'OG002', 'lowerLimit': '41', 'upperLimit': '73'}, {'value': '45', 'groupId': 'OG003', 'lowerLimit': '35', 'upperLimit': '55'}]}]}, {'title': 'POD 2 Total Opioid Use (mg)', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '57', 'upperLimit': '85'}, {'value': '60', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '70'}, {'value': '63', 'groupId': 'OG002', 'lowerLimit': '47', 'upperLimit': '79'}, {'value': '55', 'groupId': 'OG003', 'lowerLimit': '43', 'upperLimit': '65'}]}]}, {'title': 'POD 3 Total Opioid Use (mg)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000', 'lowerLimit': '43', 'upperLimit': '67'}, {'value': '60', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '70'}, {'value': '40', 'groupId': 'OG002', 'lowerLimit': '30', 'upperLimit': '50'}, {'value': '36', 'groupId': 'OG003', 'lowerLimit': '30', 'upperLimit': '42'}]}]}, {'title': 'POD 14 Total Opioid Use (mg)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '50'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '45'}, {'value': '40', 'groupId': 'OG002', 'lowerLimit': '30', 'upperLimit': '50'}, {'value': '45', 'groupId': 'OG003', 'lowerLimit': '25', 'upperLimit': '55'}]}]}, {'title': '3 months Total Opioid Use (mg)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '6'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Opioid Usage (POD1, POD 3, 2 weeks, 3 months)', 'unitOfMeasure': 'mg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Patients will receive 0mg of pregabalin\n\nPlacebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'OG001', 'title': '50mg Arm', 'description': 'Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'OG002', 'title': '100mg Arm', 'description': 'Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'OG003', 'title': '150mg Arm', 'description': 'Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '10'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '10'}, {'value': '8', 'groupId': 'OG002', 'lowerLimit': '5', 'upperLimit': '9'}, {'value': '8', 'groupId': 'OG003', 'lowerLimit': '6', 'upperLimit': '9.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 weeks', 'description': 'Satisfaction with pain management (1-10 scale; 1 = very dissatisfied, 10 = very satisfied)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'Patients will receive 0mg of pregabalin\n\nPlacebo: Patients will receive placebo drug with no active ingredients per dose.'}, {'id': 'FG001', 'title': '50mg Arm', 'description': 'Patients will receive 50mg of pregabalin per dose.'}, {'id': 'FG002', 'title': '100mg Arm', 'description': 'Patients will receive 100mg of pregabalin per dose.'}, {'id': 'FG003', 'title': '150mg Arm', 'description': 'Patients will receive 150mg of pregabalin per dose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Unable to complete study procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Patients will receive 0mg of pregabalin\n\nPlacebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'BG001', 'title': '50mg Arm', 'description': 'Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'BG002', 'title': '100mg Arm', 'description': 'Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'BG003', 'title': '150mg Arm', 'description': 'Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.\n\nPregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.5', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '66.8', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '65.1', 'spread': '7.1', 'groupId': 'BG002'}, {'value': '67.7', 'spread': '8.1', 'groupId': 'BG003'}, {'value': '66.3', 'spread': '7.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '32', 'spread': '5', 'groupId': 'BG000'}, {'value': '32', 'spread': '6', 'groupId': 'BG001'}, {'value': '32', 'spread': '6', 'groupId': 'BG002'}, {'value': '30', 'spread': '7', 'groupId': 'BG003'}, {'value': '31.5', 'spread': '2.45', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m ^ 2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-12', 'studyFirstSubmitDate': '2011-04-08', 'resultsFirstSubmitDate': '2015-07-21', 'studyFirstSubmitQcDate': '2011-04-11', 'lastUpdatePostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-12', 'studyFirstPostDateStruct': {'date': '2011-04-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain', 'timeFrame': '2 weeks postoperatively', 'description': 'Pain assessment scale (Numeric Rating Scale) (0=no pain; 10=worst pain imaginable).'}], 'secondaryOutcomes': [{'measure': 'Opioid-Related Symptom Distress Score', 'timeFrame': '2 weeks postoperatively', 'description': 'Opioid-Related Symptom Distress score (ORSDS) measured at POD1 and POD14. The ORSDS is a 4-point scale that evaluates 3 symptom distress dimensions (frequency, severity, bothersomeness) for 12 symptoms. The symptom-specific ORSDS is the average of the 3 symptom distress dimensions. The composite ORSDS is the average of 12 symptom-specific scores. (0=low; 4=high).'}, {'measure': 'Self-assessed Sedation and Confusion', 'timeFrame': '1 day postoperatively', 'description': 'Self-assessed sedation and confusion (POD1). Confusion Assessment Method (CAM score) (pre-operative and on POD1)'}, {'measure': 'Numeric Rating Scale (NRS)', 'timeFrame': '3 months', 'description': 'NRS Pain (pre-operative, POD1, POD3, 2 weeks, 3 months, at orthopedic visits). Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months)'}, {'measure': 'Neuropathic Pain', 'timeFrame': '3 months', 'description': 'Neuropathic pain incidence: Leeds assessment of neuropathic symptoms and signs (LANSS) score (3 months). Scale of 0 to 24. Higher values represent worse outcomes.'}, {'measure': 'Opioid Usage', 'timeFrame': '3 months', 'description': 'Opioid Usage (POD1, POD 3, 2 weeks, 3 months)'}, {'measure': 'Satisfaction', 'timeFrame': '2 weeks', 'description': 'Satisfaction with pain management (1-10 scale; 1 = very dissatisfied, 10 = very satisfied)'}]}, 'conditionsModule': {'conditions': ['Primary Total Knee Arthroplasty']}, 'referencesModule': {'references': [{'pmid': '26170351', 'type': 'DERIVED', 'citation': 'YaDeau JT, Lin Y, Mayman DJ, Goytizolo EA, Alexiades MM, Padgett DE, Kahn RL, Jules-Elysee KM, Ranawat AS, Bhagat DD, Fields KG, Goon AK, Curren J, Westrich GH. Pregabalin and pain after total knee arthroplasty: a double-blind, randomized, placebo-controlled, multidose trial. Br J Anaesth. 2015 Aug;115(2):285-93. doi: 10.1093/bja/aev217.'}]}, 'descriptionModule': {'briefSummary': 'Total knee arthroplasty can cause severe postoperative pain, and patients typically receive oral opioid analgesics for over 2 weeks. Side effects of pain management may impair participation in physical therapy and diminish patient satisfaction. Anecdotally, it seems that pregabalin is very helpful to patients after total knee arthroplasty. However, pregabalin can have side effects. It is not clear how much pregabalin to prescribe. Low doses may not be effective, but use of high doses may increase the incidence and severity of side effects.The purpose of this study is to determine which dosage of pregabalin is the most effective at reducing pain after knee surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon\n* Age 18 to 80 years old\n* Planned use of regional anesthesia\n* Ability to follow study protocol\n* English speaking (primary outcome obtained via telephone call and secondary outcomes include questionnaires validated in English only)\n* Patients planning on being discharged home or to a rehabilitation center that has agreed to participate\n\nExclusion Criteria:\n\n* Patients younger than 18 years old and older than 80\n* Patients intending to receive general anesthesia\n* Allergy or intolerance to one of the study medications\n* Patients with an ASA of IV\n* Patients with hepatic (liver) failure\n* Patients with chronic renal (kidney) failure (Defined as estimated creatinine clearance \\< 30 mL/min, based on recommendation that total daily pregabalin dose be reduced to 150 mg with Clcr \\< 30 mL/min, CLcr=\\[(140-age (years)\\] x weight (kg)x0.85 (for female patients)/\\[72xserum creatinine (mg/dL)\\])\n* Patients with difficult to manage diabetes mellitus, including insulin-dependence\n* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)\n* Chronic opioid use (taking opioids for longer than 3 months)\n* Patients with major prior ipsilateral open knee surgery.\n* Chronic neurontin/lyrica use'}, 'identificationModule': {'nctId': 'NCT01333956', 'briefTitle': 'Effects of Pregabalin on Pain After Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'Effects of Pregabalin on Pain After Total Knee Arthroplasty: A Randomized, Controlled, Double-Blind Trial', 'orgStudyIdInfo': {'id': '11043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Patients will receive 0mg of pregabalin', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '50mg Arm', 'description': 'Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of post-operative day (POD)14 and one capsule at bedtime POD15, POD16.', 'interventionNames': ['Drug: Pregabalin 50mg']}, {'type': 'EXPERIMENTAL', 'label': '100mg Arm', 'description': 'Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.', 'interventionNames': ['Drug: Pregabalin 100mg']}, {'type': 'EXPERIMENTAL', 'label': '150mg Arm', 'description': 'Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.', 'interventionNames': ['Drug: Pregabalin 150mg']}], 'interventions': [{'name': 'Pregabalin 50mg', 'type': 'DRUG', 'otherNames': ['Lyrica'], 'description': 'Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.', 'armGroupLabels': ['50mg Arm']}, {'name': 'Pregabalin 100mg', 'type': 'DRUG', 'otherNames': ['Lyrica'], 'description': 'Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.', 'armGroupLabels': ['100mg Arm']}, {'name': 'Pregabalin 150mg', 'type': 'DRUG', 'otherNames': ['Lyrica'], 'description': 'Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.', 'armGroupLabels': ['150mg Arm']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jacques T YaDeau, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Special Surgery, New York'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}