Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-30 @ 8:21 AM
Study NCT ID:
NCT05214157
Status:
COMPLETED
Last Update Posted:
2022-01-28
First Post:
2022-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Pain Management Following Laparoscopic Cholecystectomy RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 804}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-27', 'studyFirstSubmitDate': '2022-01-25', 'studyFirstSubmitQcDate': '2022-01-27', 'lastUpdatePostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pain intensity', 'timeFrame': '6 - 24 hours', 'description': 'severity by visual analogue scale'}], 'secondaryOutcomes': [{'measure': 'hospital stay', 'timeFrame': '1-5 days', 'description': 'numbers of days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Post-operative Pain', 'Cholecystectomy, Laparoscopic', 'Pain Assessment Pain Intensity', 'Pain Intensity']}, 'descriptionModule': {'briefSummary': 'evaluating the two final steps we added to optimize post laparoscopic cholecystectomy pain management.', 'detailedDescription': 'Introduction: After a laparoscopic cholecystectomy (LC), pain is still a significant concern, leading to extended hospital stays or readmissions. In majority of patients, postoperative pain medications are required. A standardized strategy is needed to offer effective pain relief postoperatively. The majority of pain in the early postoperative period is due to elimination of intraperitoneal surface tension or of parietal type. Aim of the work: to evaluate the two final steps we added to optimize postoperative pain management. Patients and methods: Over the period from March 2020 to December 2021, 816 patients with gallbladder stone undergoing LC were randomized into 2 groups after exclusion of 12 patients: Group A; interventional contained 402 patients. Group B; control contained 402 patients. Post-operative data to be compared were made in terms of operative time, shoulder pain, upper abdominal pain, (at 6,12,18 and 24 hours) and number of analgesic doses and hospital stay. Pain intensity was assessed by using the visual analogue scale (VAS) for each patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who were having symptoms consistent with biliary colic,\n* had ultrasound evidence of gall stones,\n* classified as American Society of Anesthesiology (ASA) I and II\n* ages ranging from 18 to 65 years\n\nExclusion Criteria:\n\n* Patients who refused to give consent,\n* pregnant,\n* had a history of drug abuse,\n* had CBD stones,\n* acute cholecystitis,\n* acute pancreatitis,\n* previous abdominal surgery,\n* history of peritonitis,\n* had carcinoma of the gall bladder Patients who were converted to open surgery,\n* patients who required placement of drains\n* patients with intraoperative complications (CBD injury or liver bed bleeding).'}, 'identificationModule': {'nctId': 'NCT05214157', 'acronym': 'Pain', 'briefTitle': 'Optimizing Pain Management Following Laparoscopic Cholecystectomy RCT', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'A Prospective Randomized Controlled Study on the Role of Restoring Liver-Diaphragm Surface Tension and Pain Control at Port Sites in Optimizing Pain Management Following Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': 'zuh 243'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group A', 'description': 'interventional group, final two operative steps applied', 'interventionNames': ['Procedure: active gas aspiration']}, {'type': 'NO_INTERVENTION', 'label': 'group B', 'description': 'control group'}], 'interventions': [{'name': 'active gas aspiration', 'type': 'PROCEDURE', 'otherNames': ['application of Bupivacaine soaked sponge'], 'description': 'sucking remaining Co2 from the peritoneal cavity and local anaesthetic application at port sites', 'armGroupLabels': ['group A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zagazig', 'country': 'Egypt', 'facility': 'Zagazig University', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'overallOfficials': [{'name': 'mohamed l ali, md', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zagazig University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Mohamed lotfy', 'investigatorAffiliation': 'Zagazig University'}}}}