Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2026-01-03 @ 3:50 AM
Study NCT ID:
NCT06605235
Status:
COMPLETED
Last Update Posted:
2024-09-20
First Post:
2024-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Ideal Local Anesthetic for Intraperitoneal Gallbladder Bed Infiltration Following Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000772', 'term': 'Anesthesia, Local'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-19', 'studyFirstSubmitDate': '2024-09-14', 'studyFirstSubmitQcDate': '2024-09-19', 'lastUpdatePostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale - pain score', 'timeFrame': '2-, 6-, 12-, 24-hours following surgery', 'description': 'Visual analogue score to quantify pain following laparoscopic cholecystectomy. Maximum value is 10 (which means worst pain), and minimum value is 0 (which means no pain).'}], 'secondaryOutcomes': [{'measure': 'Shoulder tip pain', 'timeFrame': 'within 24 hours following surgery', 'description': 'The time following surgery when shoulder tip pain was gone'}, {'measure': 'Flatus', 'timeFrame': 'within 24 hours following surgery', 'description': 'Time to passing flatus'}, {'measure': 'nausea/vomiting', 'timeFrame': 'within 24 hours following surgery', 'description': 'time when nausea/vomiting was not present in the patient'}, {'measure': 'Time to ambulation', 'timeFrame': 'within 24 hours following surgery', 'description': 'time after surgery when the patient started ambulating'}, {'measure': 'rescue analgesia', 'timeFrame': 'within 24 hours following surgery', 'description': 'number of times rescue analgesia was used'}, {'measure': 'Mean arterial pressure', 'timeFrame': '2-, 6-, 12-, 24-hours following surgery', 'description': 'systolic and diastolic blood pressures were measured for the patients at intervals, and then mean arterial pressures were calculated'}, {'measure': 'Heart rate', 'timeFrame': '2-, 6-, 12-, 24 hours', 'description': 'Heart rate was measured at intervals in beats per minute'}, {'measure': 'oxygen saturation', 'timeFrame': '2-, 6-, 12-, 24 hours', 'description': 'oxygen saturation was noted at intervals'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laparoscopic cholecystectomy', 'lignocaine', 'bupivacaine', 'visual analogue scale'], 'conditions': ['Cholecystectomy, Laparoscopic', 'Pain Management']}, 'referencesModule': {'references': [{'pmid': '24886449', 'type': 'BACKGROUND', 'citation': 'Yeh CN, Tsai CY, Cheng CT, Wang SY, Liu YY, Chiang KC, Hsieh FJ, Lin CC, Jan YY, Chen MF. Pain relief from combined wound and intraperitoneal local anesthesia for patients who undergo laparoscopic cholecystectomy. BMC Surg. 2014 May 12;14:28. doi: 10.1186/1471-2482-14-28.'}, {'pmid': '27324337', 'type': 'BACKGROUND', 'citation': 'Protic M, Veljkovic R, Bilchik AJ, Popovic A, Kresoja M, Nissan A, Avital I, Stojadinovic A. Prospective randomized controlled trial comparing standard analgesia with combined intra-operative cystic plate and port-site local anesthesia for post-operative pain management in elective laparoscopic cholecystectomy. Surg Endosc. 2017 Feb;31(2):704-713. doi: 10.1007/s00464-016-5024-5. Epub 2016 Jun 20.'}, {'pmid': '15457350', 'type': 'BACKGROUND', 'citation': 'Inan A, Sen M, Dener C. Local anesthesia use for laparoscopic cholecystectomy. World J Surg. 2004 Aug;28(8):741-4. doi: 10.1007/s00268-004-7350-3. Epub 2004 Aug 3.'}, {'pmid': '23355159', 'type': 'BACKGROUND', 'citation': 'Donatsky AM, Bjerrum F, Gogenur I. Intraperitoneal instillation of saline and local anesthesia for prevention of shoulder pain after laparoscopic cholecystectomy: a systematic review. Surg Endosc. 2013 Jul;27(7):2283-92. doi: 10.1007/s00464-012-2760-z. Epub 2013 Jan 26.'}, {'pmid': '16931681', 'type': 'BACKGROUND', 'citation': 'Boddy AP, Mehta S, Rhodes M. The effect of intraperitoneal local anesthesia in laparoscopic cholecystectomy: a systematic review and meta-analysis. Anesth Analg. 2006 Sep;103(3):682-8. doi: 10.1213/01.ane.0000226268.06279.5a.'}, {'pmid': '1482431', 'type': 'BACKGROUND', 'citation': 'Ejlersen E, Andersen HB, Eliasen K, Mogensen T. A comparison between preincisional and postincisional lidocaine infiltration and postoperative pain. Anesth Analg. 1992 Apr;74(4):495-8. doi: 10.1213/00000539-199204000-00004.'}, {'pmid': '15473621', 'type': 'BACKGROUND', 'citation': 'Ng A, Swami A, Smith G, Robertson G, Lloyd DM. Is intraperitoneal levobupivacaine with epinephrine useful for analgesia following laparoscopic cholecystectomy? A randomized controlled trial. Eur J Anaesthesiol. 2004 Aug;21(8):653-7. doi: 10.1017/s0265021504008117.'}, {'pmid': '34693999', 'type': 'BACKGROUND', 'citation': 'Rutherford D, Massie EM, Worsley C, Wilson MS. Intraperitoneal local anaesthetic instillation versus no intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD007337. doi: 10.1002/14651858.CD007337.pub4.'}, {'pmid': '8480874', 'type': 'BACKGROUND', 'citation': 'Strasberg SM, Clavien PA. Overview of therapeutic modalities for the treatment of gallstone diseases. Am J Surg. 1993 Apr;165(4):420-6. doi: 10.1016/s0002-9610(05)80933-x.'}, {'type': 'BACKGROUND', 'citation': 'Rance, G. and A. Jones, Gallstone disease. InnovAiT, 2016. 9(1): p. 7.'}, {'pmid': '20478480', 'type': 'BACKGROUND', 'citation': 'Stinton LM, Myers RP, Shaffer EA. Epidemiology of gallstones. Gastroenterol Clin North Am. 2010 Jun;39(2):157-69, vii. doi: 10.1016/j.gtc.2010.02.003.'}]}, 'descriptionModule': {'briefSummary': 'To control pain after surgery for removal of gallbladder, local anesthetic agent can be sprayed on the liver bed from where the gallbladder is removed. This study was conducted to identify the ideal local anesthetic agent for this purpose.', 'detailedDescription': 'Laparoscopic cholecystectomy is the gold standard operation for symptomatic cholelithiasis; however, pain remains a major factor increasing morbidity and length of hospital stay. Infiltration of gallbladder bed with local anesthetic has been shown to improve post-operative pain after laparoscopic cholecystectomy, although, it is unclear which local anesthetic provides superior pain relief. Patients undergoing laparoscopic cholecystectomies were randomized into 3 groups of 30 patients each depending on the local anesthetic instilled in the gallbladder bed; lignocaine (Group A), bupivacaine (Group B), or a combination of lignocaine and bupivacaine (Group C). Pain was measured using visual analogue score at 2-, 6-, 12- and 24-hours following surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective/emergency laparoscopic cholecystectomy\n* ASA grade I/II\n* Ages 18-75 years\n\nExclusion Criteria:\n\n* patients on chronic analgesics\n* pts receiving analgesics 24 hours prior to surgery\n* intraoperative bile spillage or drain placement\n* CBD exploration or T-tube insertion\n* BMI \\> 40 kg/m2\n* pts allergic to, or otherwise not able to receive medications being tested'}, 'identificationModule': {'nctId': 'NCT06605235', 'briefTitle': 'The Ideal Local Anesthetic for Intraperitoneal Gallbladder Bed Infiltration Following Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Pakistan Air Force (PAF) Hospital Islamabad'}, 'officialTitle': 'The Ideal Local Anesthetic for Intraperitoneal Gallbladder Bed Infiltration Following Laparoscopic Cholecystectomy - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SGR-2021-137-2499-1'}, 'secondaryIdInfos': [{'id': 'SGR-2021-137-2499-1', 'type': 'OTHER', 'domain': 'PAF Hospital ethical committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lignocaine', 'description': 'patients received 20 ml of 1% lignocaine (Xyloaid-lignocaine HCl injection) infiltrated in the gall bladder bed after removal of the gall bladder, along with 10 ml of 1% lignocaine infiltration at the port sites at the end of the procedure', 'interventionNames': ['Procedure: Local Anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'Bupivacaine', 'description': 'Subjects received 20 ml of 0.25% bupivacaine (Bupicain-Bupivacaine HCl injection) infiltration in gall bladder bed, along with 10 ml of 0.25% bupivacaine at port sites', 'interventionNames': ['Procedure: Local Anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'Lignocaine + Bupivacaine', 'description': 'patients received 10 ml of 1% lignocaine along with 10 ml of 0.25% bupivacaine infiltrated in gall bladder bed, and then 5 ml of 1% lignocaine along with 5 ml of 0.25% bupivacaine at the port sites', 'interventionNames': ['Procedure: Local Anesthesia']}], 'interventions': [{'name': 'Local Anesthesia', 'type': 'PROCEDURE', 'description': 'In Group A, patients received 20 ml of 1% lignocaine (Xyloaid-lignocaine HCl injection) infiltrated in the gall bladder bed after removal of the gall bladder, along with 10 ml of 1% lignocaine infiltration at the port sites at the end of the procedure. Subjects in Group B received 20 ml of 0.25% bupivacaine (Bupicain-Bupivacaine HCl injection) infiltration in gall bladder bed, along with 10 ml of 0.25% bupivacaine at port sites. In Group C patients received 10 ml of 1% lignocaine along with 10 ml of 0.25% bupivacaine infiltrated in gall bladder bed, and then 5 ml of 1% lignocaine along with 5 ml of 0.25% bupivacaine at the port sites', 'armGroupLabels': ['Bupivacaine', 'Lignocaine', 'Lignocaine + Bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Islamabad', 'state': 'Capital Territory', 'country': 'Pakistan', 'facility': 'PAF hospital', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pakistan Air Force (PAF) Hospital Islamabad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post-graduate resident, Principle Investigator, Department of General Surgery', 'investigatorFullName': 'Syed Moiz Ahmed', 'investigatorAffiliation': 'Pakistan Air Force (PAF) Hospital Islamabad'}}}}