Clinical trial NCT06605235: The Ideal Local Anesthetic for Intraperitoneal Gallbladder Bed Infiltration Following Laparoscopic Cholecystectomy
Official title: The Ideal Local Anesthetic for Intraperitoneal Gallbladder Bed Infiltration Following Laparoscopic Cholecystectomy - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystectomy, Laparoscopic
Pain Management
Keywords: laparoscopic cholecystectomy
lignocaine
bupivacaine
visual analogue scale
Lead sponsor: Pakistan Air Force (PAF) Hospital Islamabad
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Eligibility criteria: 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 \&gt; 40 kg/m2
* pts allergic to, or otherwise not able to receive medications being tested

Primary outcomes:
measure: Visual analogue scale - pain score
timeFrame: 2-, 6-, 12-, 24-hours following surgery
Secondary outcomes:
measure: Shoulder tip pain
timeFrame: within 24 hours following surgery
measure: Flatus
timeFrame: within 24 hours following surgery
measure: nausea/vomiting
timeFrame: within 24 hours following surgery
measure: Time to ambulation
timeFrame: within 24 hours following surgery
measure: rescue analgesia
timeFrame: within 24 hours following surgery
measure: Mean arterial pressure
timeFrame: 2-, 6-, 12-, 24-hours following surgery
measure: Heart rate
timeFrame: 2-, 6-, 12-, 24 hours
measure: oxygen saturation
timeFrame: 2-, 6-, 12-, 24 hours
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: PAF hospital
state: Capital territory
Study officials:
References:
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