Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT05590767
Status:
COMPLETED
Last Update Posted:
2024-05-03
First Post:
2022-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pupillary Pain Index to Evaluate Interscalene Block and Postoperative Pain in Patients Underwent Shoulder Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'luyihsiung@gmail.com', 'phone': '+886933429559', 'title': 'Dr. Lu Yi-Hsiung', 'organization': 'Tri-Service General Hospital, National Defense Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "the pupillometer's built-in PPI mode utilizes electrical stimulation up to 60 mA to simulate nociception. Therefore, the patient must be under sedation or anesthesia during the measurement to ensure comfort and safety."}}, 'adverseEventsModule': {'timeFrame': '2 days', 'eventGroups': [{'id': 'EG000', 'title': 'Shoulder Rotators Repair', 'description': 'Patients scheduled to undergo shoulder rotators repair surgery\n\nPatients scheduled to undergo shoulder rotators repair surgery: Patients scheduled to undergo shoulder rotators repair surgery, and received combined general anesthesia and interscalene block', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pupillary Pain Index (PPI )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Shoulder Rotators Repair', 'description': 'Patients scheduled to undergo shoulder rotators repair surgery\n\nPatients scheduled to undergo shoulder rotators repair surgery: Patients scheduled to undergo shoulder rotators repair surgery, and received combined general anesthesia and interscalene block'}], 'classes': [{'title': 'ISB side', 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'Control side', 'categories': [{'measurements': [{'value': '6.6', 'spread': '0.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After induction of anesthesia and before surgical incision', 'description': 'The primary outcome is the difference of the pupillary pain index (PPI ) between the ISB side and the control side The PPI mode applies a standardized, incremental transcutaneous electrical stimulation (100 Hz, 10-60mA, with 1-s intervals) that progressively increases in intensity until a pupil dilation of \\>13% is observed. The degree of reflex dilation is quantified on a scale of 1 (very deep analgesia) to 9 (very light analgesia) and referred to as the PPI .', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '40 patients scheduled for rotator cuff surgery were recruited for this study. Of these, three did not follow the study protocol: one had canceled surgery, one did not undergo ISB, and in one case, sevoflurane was not used as the main anesthetic. For the remaining 37 patients, Three patients did not report a loss of subjective cold/pinprick sensation in the C5 and C6 dermatomes, indicating an unsuccessful block. Therefore, 34 patients were included in the final analysis.'}, {'type': 'SECONDARY', 'title': 'Difference Between Intraoperative Pupillary Pain Index (PPI) and Postoperative Numerical Pain Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Shoulder Rotators Repair', 'description': 'Patients scheduled to undergo shoulder rotators repair surgery\n\nPatients scheduled to undergo shoulder rotators repair surgery: Patients scheduled to undergo shoulder rotators repair surgery, and received combined general anesthesia and interscalene block'}], 'classes': [{'title': 'intraoperative PPI', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'postoperative NRS', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From emergency of anesthesia to early Post-anesthesia period', 'description': '1. PPI: The PPI mode applies a standardized, incremental transcutaneous electrical stimulation (100 Hz, 10-60mA, with 1-s intervals) that progressively increases in intensity until a pupil dilation of \\>13% is observed. The degree of reflex dilation is quantified on a scale of 1 (very deep analgesia) to 9 (very light analgesia) and referred to as the PPI.\n2. NRS: the nursing staff in the post-anesthesia care unit asked the patient to rate their pain at the surgical site using the NRS, with a range of 0(no pain)-10(most severe pain).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '40 patients scheduled for rotator cuff surgery were recruited for this study. Of these, three did not follow the study protocol: one had canceled surgery, one did not undergo ISB, and in one case, sevoflurane was not used as the main anesthetic. For the remaining 37 patients, Three patients did not report a loss of subjective cold/pinprick sensation in the C5 and C6 dermatomes, indicating an unsuccessful block. Therefore, 34 patients were included in the final analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Shoulder Rotators Repair', 'description': 'Patients scheduled to undergo shoulder rotators repair surgery\n\nPatients scheduled to undergo shoulder rotators repair surgery: Patients scheduled to undergo shoulder rotators repair surgery, and received combined general anesthesia and interscalene block'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'surgery canceled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'interscalene brachial block not performed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Shoulder Rotators Repair', 'description': 'Patients scheduled to undergo shoulder rotators repair surgery\n\nPatients scheduled to undergo shoulder rotators repair surgery: Patients scheduled to undergo shoulder rotators repair surgery, and received combined general anesthesia and interscalene block'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '62', 'spread': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years old', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '24.1', 'spread': '2.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index (BMI) units: kg/m\\^2 Mean (Standard Deviation)', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': '40 patients scheduled for rotator cuff surgery were recruited for this study. Of these, three did not follow the study protocol: one had canceled surgery, one did not undergo ISB, and in one case, sevoflurane was not used as the main anesthetic. For the remaining 37 patients, Three patients did not report a loss of subjective cold/pinprick sensation in the C5 and C6 dermatomes, indicating an unsuccessful block. Therefore, 34 patients were included in the final analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-20', 'size': 119765, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-02T22:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-01', 'studyFirstSubmitDate': '2022-10-18', 'resultsFirstSubmitDate': '2023-11-04', 'studyFirstSubmitQcDate': '2022-10-18', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-01', 'studyFirstPostDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pupillary Pain Index (PPI )', 'timeFrame': 'After induction of anesthesia and before surgical incision', 'description': 'The primary outcome is the difference of the pupillary pain index (PPI ) between the ISB side and the control side The PPI mode applies a standardized, incremental transcutaneous electrical stimulation (100 Hz, 10-60mA, with 1-s intervals) that progressively increases in intensity until a pupil dilation of \\>13% is observed. The degree of reflex dilation is quantified on a scale of 1 (very deep analgesia) to 9 (very light analgesia) and referred to as the PPI .'}], 'secondaryOutcomes': [{'measure': 'Difference Between Intraoperative Pupillary Pain Index (PPI) and Postoperative Numerical Pain Scale (NRS)', 'timeFrame': 'From emergency of anesthesia to early Post-anesthesia period', 'description': '1. PPI: The PPI mode applies a standardized, incremental transcutaneous electrical stimulation (100 Hz, 10-60mA, with 1-s intervals) that progressively increases in intensity until a pupil dilation of \\>13% is observed. The degree of reflex dilation is quantified on a scale of 1 (very deep analgesia) to 9 (very light analgesia) and referred to as the PPI.\n2. NRS: the nursing staff in the post-anesthesia care unit asked the patient to rate their pain at the surgical site using the NRS, with a range of 0(no pain)-10(most severe pain).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgery', 'Shoulder Impingement']}, 'descriptionModule': {'briefSummary': 'When an individual encounters nociceptive pain stimuli, the pupil dilates in a unique manner known as Pupil reflex dilation (PRD).The degree of pupillary reflex dilatation can be further quantified into an objective parameter, termed the Pupillary pain index (PPI), as a monitoring tool for the balance between nociception and antinociception in surgical patients The motivation for this study is to investigate the feasibility of using pupillometry to assess acute pain after shoulder surgery. The purpose of the study is as follows: (1) Can PDR in patients undergoing general anesthesia be used to assess the analgesic effect of interscalene block? (2) Does PPI at the end of surgical anesthesia in such patients correlate with the first numerical pain scale (NRS) during the recovery room?', 'detailedDescription': 'When an individual encounters nociceptive pain stimuli, the pupil dilates in a unique way called pupillary reflex dilation (PRD), which can be observed both when the individual is awake or under anesthesia. The degree of pupillary reflex dilatation can be further quantified into an objective parameter called the Pupillary pain index (PPI), which serves as a monitoring tool for the balance between nociception and antinociception in surgical patients. Larson studied 32 female breast surgery patients who received general anesthesia combined with thoracic paravertebral nerve block on the affected side. The results showed that the affected side of the nerve block had significantly lower pupillary reflex dilation than those without nerve block on the healthy side of the breast. The authors believed that this study confirmed the value of pupillary reflex dilation in monitoring the success rate of unilateral thoracic paravertebral nerve block during general anesthesia. In a prospective observational study of 26 patients undergoing neurosurgery under general anesthesia, Pupillary pain index at the end of surgical anesthesia and Numerical Rating Scale (NRS) during the recovery room were recorded separately, The results showed a significant correlation between the two parameters (rS = 0.62; P = 0.002). The authors concluded that the application of the measurement of pupillary reflex dilation may be useful in predicting and preventing acute postoperative pain. Shoulder rotator muscle repair is a common surgery in our hospital. Patients must receive general anesthesia, sometimes combined with scalene interscalene block (ISB), to improve postoperative acute pain ,help to perform passive shoulder rehabilitation exercises and prevent shoulder joint adhesions. Based on the above literature review, the motivation for this study was to investigate the feasibility of using pupillometry to assess acute pain after shoulder surgery. The objectives of the research project are as follows: 1. Can pupillary reflex dilation in patients undergoing general anesthesia be used to assess the analgesic effect of scalene nerve block? 2. Is the pupillary pain index (PPI) at the end of surgical anesthesia correlated with the first numerical pain scale (NRS) during the recovery room in such patients?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled to undergo shoulder rotators repair surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who received general anesthesia combined with ipsilateral interscalene block\n* Patients listed as a Class I/II physical condition of the American Society ofAnesthesiologists\n\nExclusion Criteria:\n\n* Patients younger than 20 years of age\n* The presence of ophthalmologic (recent eye surgery or cataracts) or neurologic diseases (diabetic neuropathy,or postherpetic neuralgia) that could interfere with Pupillometer'}, 'identificationModule': {'nctId': 'NCT05590767', 'briefTitle': 'Pupillary Pain Index to Evaluate Interscalene Block and Postoperative Pain in Patients Underwent Shoulder Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Tri-Service General Hospital'}, 'officialTitle': 'Department of Anesthesiology, Tri-Service General Hospital and National Defense Medical Center , Taipei, Taiwan', 'orgStudyIdInfo': {'id': 'C202205095'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'shoulder rotators repair', 'description': 'Patients scheduled to undergo shoulder rotators repair surgery', 'interventionNames': ['Procedure: Patients scheduled to undergo shoulder rotators repair surgery']}], 'interventions': [{'name': 'Patients scheduled to undergo shoulder rotators repair surgery', 'type': 'PROCEDURE', 'description': 'Patients scheduled to undergo shoulder rotators repair surgery, and received combined general anesthesia and interscalene block', 'armGroupLabels': ['shoulder rotators repair']}]}, 'contactsLocationsModule': {'locations': [{'zip': '114', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Department of Anesthesiology, Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Yeh Chun-chang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology, Tri-Service General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tri-Service General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending doctor, Department of Anesthesiology', 'investigatorFullName': 'Lu Yihsiung', 'investigatorAffiliation': 'Tri-Service General Hospital'}}}}