The Ideal Local Anesthetic for Intraperitoneal Gallbladder Bed Infiltration Following Laparoscopic Cholecystectomy
NCT ID: NCT06605235
Last Updated: 2024-09-20
Study Results
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Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2024-01-01
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Lignocaine
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
Local Anesthesia
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
Bupivacaine
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
Local Anesthesia
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
Lignocaine + Bupivacaine
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
Local Anesthesia
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
Interventions
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Local Anesthesia
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
Eligibility Criteria
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Inclusion Criteria
* ASA grade I/II
* Ages 18-75 years
Exclusion Criteria
* pts receiving analgesics 24 hours prior to surgery
* intraoperative bile spillage or drain placement
* CBD exploration or T-tube insertion
* BMI \> 40 kg/m2
* pts allergic to, or otherwise not able to receive medications being tested
18 Years
75 Years
ALL
No
Sponsors
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Pakistan Air Force (PAF) Hospital Islamabad
OTHER
Responsible Party
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Syed Moiz Ahmed
Post-graduate resident, Principle Investigator, Department of General Surgery
Locations
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PAF hospital
Islamabad, Capital Territory, Pakistan
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Rance, G. and A. Jones, Gallstone disease. InnovAiT, 2016. 9(1): p. 7.
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.
Other Identifiers
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SGR-2021-137-2499-1
Identifier Type: OTHER
Identifier Source: secondary_id
SGR-2021-137-2499-1
Identifier Type: -
Identifier Source: org_study_id
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