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

NCT06605235 | Completed

• 1 other identifier: SGR-2021-137-2499-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholecystectomy, Laparoscopic; Pain Management

Keywords

laparoscopic cholecystectomy; lignocaine; bupivacaine; visual analogue scale

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Shoulder tip pain

  within 24 hours following surgery

• Flatus

  within 24 hours following surgery

• nausea/vomiting

  within 24 hours following surgery

• Time to ambulation

  within 24 hours following surgery

• rescue analgesia

  within 24 hours following surgery

Study Arms (3)

Lignocaine

EXPERIMENTAL

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

Bupivacaine

EXPERIMENTAL

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

Lignocaine + Bupivacaine

EXPERIMENTAL

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

Interventions

Local Anesthesia PROCEDURE

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; Lignocaine; Lignocaine + Bupivacaine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pakistan Air Force (PAF) Hospital Islamabad: lead

Study Sites (1)

PAF hospital

Islamabad, Capital Territory, 44000, Pakistan

Location

Related Publications (11)

• 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: 24886449 BACKGROUND

• 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: 27324337 BACKGROUND

• 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: 15457350 BACKGROUND

• 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: 23355159 BACKGROUND

• 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: 16931681 BACKGROUND

• 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: 1482431 BACKGROUND

• 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: 15473621 BACKGROUND

• 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: 34693999 BACKGROUND

• 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.

  PMID: 8480874 BACKGROUND

• Rance, G. and A. Jones, Gallstone disease. InnovAiT, 2016. 9(1): p. 7.

  BACKGROUND

• 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.

  PMID: 20478480 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-graduate resident, Principle Investigator, Department of General Surgery

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: September 20, 2024
• Study Start: January 1, 2024
• Primary Completion: June 28, 2024
• Study Completion: June 30, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)