Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-27 @ 6:48 PM
Study NCT ID:
NCT04457557
Status:
UNKNOWN
Last Update Posted:
2022-09-30
First Post:
2020-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Local Anesthetic Concentration and Rebound Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Only investigator who prepared the local anesthetics knows the group. Nerve block performer and outcome assessor are applied masking.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial One group received interscalene block with 0.15% of ropivacaine One group received interscalene block with 0.5% of ropivacaine'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-28', 'studyFirstSubmitDate': '2020-06-30', 'studyFirstSubmitQcDate': '2020-07-02', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rebound pain score', 'timeFrame': '48 hours after surgery', 'description': 'It is calculated by subtracting the visual analogue scale (VAS) of pain at the last time when the nerve block was effective from the highest VAS for 12 hours from the time when the nerve block effect disappeared.\n\nVAS of pain: 0=no pain \\~ 10=very severe pain'}], 'secondaryOutcomes': [{'measure': 'total postoperative fentanyl dose', 'timeFrame': '48 hours after surgery', 'description': 'Total dose of fentanyl injected (mcg) through patient controlled analgesia (PCA) for 48 hours after surgery'}, {'measure': 'fentanyl bolus injection time', 'timeFrame': '48 hours after surgery', 'description': 'Number of bolus injection times using patient controlled analgesia (PCA)'}, {'measure': 'Subjective satisfaction', 'timeFrame': '48 hours after surgery', 'description': "Patient's subjective satisfaction 48 hours after surgery Use visual analogue scale (0=very unsatisfied, 10= very satisfied)"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rebound Pain']}, 'descriptionModule': {'briefSummary': "The rebound pain after nerve block could interfere with patient's recovery and rehabilitation. It is not known how local anesthetic concentrations affect rebound pain. The aim of this study is evaluation of the effect of local anesthetic concentration on rebound pain after interscalene block for shoulder surgery.", 'detailedDescription': "Shoulder surgery is related to more than moderate pain after surgery. Interscalene nerve block could reduce the postoperative pain effectively. When the effect of nerve block ends, however, rebound pain could appear. The rebound pain could interfere with patient's recovery and rehabilitation.\n\nThe mechanism of rebound pain is not well known. One of possible mechanism is that the pain stimulus that was blocked suddenly comes out, and it is perceived as more severe pain. The strength of the block may vary depending on the concentration of the local anesthetic. Therefore, the concentration of local anesthetics could affect rebound pain. The aim of this study is evaluation of the effect of local anesthetic concentration on rebound pain after interscalene block for shoulder surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective shoulder surgery under general anesthesia and interscalene block for postoperative pain\n\nExclusion Criteria:\n\n* Contraindication of interscalene block: pulmonary disease, lung resection history, brachial nerve injury\n* Diabetic neuropathy\n* Adverse drug reaction history to ropivacaine, fentanyl\n* Impaired coagulation'}, 'identificationModule': {'nctId': 'NCT04457557', 'briefTitle': 'Local Anesthetic Concentration and Rebound Pain', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Evaluation of the Effect of Local Anesthetic Concentration on Rebound Pain After Interscalene Block for Shoulder Surgery', 'orgStudyIdInfo': {'id': 'MED-INT-20-140'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low concentration', 'description': 'Interscalene block with 0.15% ropivacaine 15 ml', 'interventionNames': ['Other: Reduced concentration of local anesthetic (ropivacaine)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual concentration', 'description': 'Interscalene block with 0.5% ropivacaine 15 ml', 'interventionNames': ['Other: Usual concentration of local anesthetic (ropivacaine)']}], 'interventions': [{'name': 'Reduced concentration of local anesthetic (ropivacaine)', 'type': 'OTHER', 'description': 'Reduced concentration of ropivacaine We usually use 0.5% ropivacaine in our facility. The intervention group used 0.15% ropivacaine 15 ml', 'armGroupLabels': ['Low concentration']}, {'name': 'Usual concentration of local anesthetic (ropivacaine)', 'type': 'OTHER', 'description': '0.5% ropivacaine 15ml', 'armGroupLabels': ['Usual concentration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16499', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'In Kyong Yi, MD', 'role': 'CONTACT', 'email': 'lyrin01@gmail.com', 'phone': '+82-10-3012-6972'}, {'name': 'Yoon Jung Chae, MD', 'role': 'CONTACT', 'phone': '+82-31-219-5689'}], 'facility': 'Ajou university school of medicine', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'centralContacts': [{'name': 'In Kyong Yi, MD', 'role': 'CONTACT', 'email': 'lyrin01@gmail.com', 'phone': '+82-31-219-7522'}], 'overallOfficials': [{'name': 'In Kyong Yi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We will provide it when we have a reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'In-kyong Yi', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}