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

P

Pakistan Air Force (PAF) Hospital Islamabad

Status

Completed

Conditions

Pain Management
Cholecystectomy, Laparoscopic

Treatments

Procedure: Local Anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT06605235
SGR-2021-137-2499-1 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment

90 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

90 participants in 3 patient groups

Lignocaine
Experimental group
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
Treatment:
Procedure: Local Anesthesia
Bupivacaine
Experimental group
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
Treatment:
Procedure: Local Anesthesia
Lignocaine + Bupivacaine
Experimental group
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
Treatment:
Procedure: Local Anesthesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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