The Ideal Local Anesthetic for Intraperitoneal Gallbladder Bed Infiltration Following Laparoscopic Cholecystectomy - a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Visual analogue scale - pain score
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Local Anesthesia (Procedure)
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
Intervention: Local Anesthesia (Procedure)
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
Intervention: Local Anesthesia (Procedure)
Outcomes
Primary Outcomes
Visual analogue scale - pain score
Time Frame: 2-, 6-, 12-, 24-hours following surgery
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).
Secondary Outcomes
- rescue analgesia(within 24 hours following surgery)
- 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)
- Mean arterial pressure(2-, 6-, 12-, 24-hours following surgery)
- Heart rate(2-, 6-, 12-, 24 hours)
- oxygen saturation(2-, 6-, 12-, 24 hours)
Investigators
Syed Moiz Ahmed
Post-graduate resident, Principle Investigator, Department of General Surgery
Pakistan Air Force (PAF) Hospital Islamabad