Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT05264805
Status:
UNKNOWN
Last Update Posted:
2022-03-03
First Post:
2022-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Port Site Bupivacaine Injection in Postoperative Pain Reduction After Lap. Chole
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group A:\n\nStudy group: Patient receiving intervention i.e 20ml of 0.25% buvivacaine infiltration at laparoscopic port site.\n\nGroup B:\n\nControl group: no intervention'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 166}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-02', 'studyFirstSubmitDate': '2022-02-04', 'studyFirstSubmitQcDate': '2022-03-02', 'lastUpdatePostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post laparoscopic port site pain assessment', 'timeFrame': 'Pain assessment from 0hour (patient received in recovery room) till 12hours postoperatively at interval of 3hours i.e. 0,3,6,9,12 hour', 'description': 'Pain assessment by "Visual Analog Scoring system" scoring from 0 to 10, where 0 means no pain and 10 means worst possible, unbearable excruciating pain.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['#Post operative pain', '#laparoscopic cholecystectomy'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'To determine the effectiveness of port site bupivacaine infiltration in postoperative pain reduction after laparoscopic cholecystectomy.', 'detailedDescription': 'The study is being done to determine the effectiveness of port site bupivacaine infiltration in postoperative pain reduction after laparoscopic cholecystectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients of both the gender of age \\>18 years and \\<45years\n2. Patients undergoing elective laparoscopic cholecystectomy under general anesthesia.\n3. Patients with A.S.A grade I and II.\n\nExclusion Criteria:\n\n1. Patients with known allergic reactions to local anesthetics.\n2. Patients converted to open procedure.\n3. Patients developing intra-operative complications.\n4. Patients undergoing for laparoscopic cholecystectomy for acute cholecystitis.\n5. Patients with obesity and chronic illness.\n6. Patients with history of opioids, steroids, NSAIDs and alcohol use.'}, 'identificationModule': {'nctId': 'NCT05264805', 'briefTitle': 'Effectiveness of Port Site Bupivacaine Injection in Postoperative Pain Reduction After Lap. Chole', 'organization': {'class': 'OTHER', 'fullName': 'Hamdard University'}, 'officialTitle': 'A Randomized Controlled Trial of Port Site Subcutaneous Injection of Bupivacaine to Determine the Effectiveness of Postoperative Pain Relief After Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': 'N0333'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bupivacaine group', 'description': 'Patient receiving 20ml of inj. 0.25% Bupivacaine at laparoscopic port site', 'interventionNames': ['Drug: 0.25% Bupivacaine']}, {'type': 'NO_INTERVENTION', 'label': 'Placebo group', 'description': 'No drug infiltration at laparoscopic port site'}], 'interventions': [{'name': '0.25% Bupivacaine', 'type': 'DRUG', 'otherNames': ['Bupivacain'], 'description': '20ml of 0.25% Bupivacaine subcutaneous infiltration at port site wound.', 'armGroupLabels': ['Bupivacaine group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dr. Nida Shahid, MBBS, FCPS', 'role': 'CONTACT', 'email': 'nida-shahid2011@hotmail.com', 'phone': '+923332358698'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamdard University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr. Nida Shahid', 'investigatorAffiliation': 'Hamdard University'}}}}