The Ideal Local Anesthetic for Intraperitoneal Gallbladder Bed Infiltration Following Laparoscopic Cholecystectomy

The Ideal Local Anesthetic for Intraperitoneal Gallbladder Bed Infiltration Following Laparoscopic Cholecystectomy - a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain Management; Cholecystectomy, Laparoscopic
• Intervention / Treatment: Procedure: Local Anesthesia

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Capital territory
    • Islamabad, Capital territory, Pakistan, 44000
      • PAF Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• elective/emergency laparoscopic cholecystectomy
• ASA grade I/II
• Ages 18-75 years

Exclusion Criteria:

• patients on chronic analgesics
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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
Experimental: 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	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
Experimental: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale - pain score	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).	2-, 6-, 12-, 24-hours following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder tip pain	The time following surgery when shoulder tip pain was gone	within 24 hours following surgery
Flatus	Time to passing flatus	within 24 hours following surgery
nausea/vomiting	time when nausea/vomiting was not present in the patient	within 24 hours following surgery
Time to ambulation	time after surgery when the patient started ambulating	within 24 hours following surgery
rescue analgesia	number of times rescue analgesia was used	within 24 hours following surgery
Mean arterial pressure	systolic and diastolic blood pressures were measured for the patients at intervals, and then mean arterial pressures were calculated	2-, 6-, 12-, 24-hours following surgery
Heart rate	Heart rate was measured at intervals in beats per minute	2-, 6-, 12-, 24 hours
oxygen saturation	oxygen saturation was noted at intervals	2-, 6-, 12-, 24 hours

Collaborators and Investigators

• Sponsor: Pakistan Air Force (PAF) Hospital Islamabad

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): June 28, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: September 14, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: bupivacaine; laparoscopic cholecystectomy; visual analogue scale; lignocaine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: SGR-2021-137-2499-1 (Other Identifier: PAF Hospital ethical committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No