To compare post operative pain relief of combination of two drugs (intraperitoneal irrigation of bupivacaine plus hydrocortisone) vs one drug (bupivacaine alone) in patients undergoing laparoscopic surgery for removal of gall bladder.

Phase 4

Not yet recruiting

• Conditions: Calculus of gallbladder with othercholecystitis,

• Registration Number: CTRI/2022/07/044059
• Lead Sponsor: Bengaluru Medical College And Research Institute

Brief Summary

Laparoscopic cholecystectomy has become a preferred modality of treatment in gall bladder surgeries. It is the gold standard for the treatment of symptomatic cholelithiasis and chronic cholecystitis. Pain is a frequent complaint following laparoscopic cholecystectomy(LC). Pain in LC can be divided into components such as parietal ,viscera and shoulder pain.Visceral pain accounts for most of the discomfort experienced in the early post operative period.Intensity quickly decreases after the first 24hrs post operatively.Shoulder tip pain dominates as visceral pain decreases. The surgical stress and insufflation of abdomen with CO2 causing rapid distention of the peritoneum may result in tearing of blood vessels ,traumatic traction of the nerves and release of inflammator meiators   causing pain.Pneumoperitoneum with CO2 is thought to cause   phrenic nerve irritation secondarily causing referred shoulder tip pain. Various drugs and methods have been studied to effectively  counter these undesirable effect . Local anaesthetics have been observed  to be effective in providing post operative analgesia in patients undergoing laparoscopic cholecystectomy .Some studies have observed that     intraperitoneal Bupivacaine does not reduce pain after laparoscopic cholecystectomy , but these studies used high concentration low volume bupivacaine intraperitoneally. It has   been demonstrated that use of  bupivacaine as low concentration high volume intraperitoneal irrigation,intraoperatively  is effective in prolonging the duration of analgesia reduces post operative rescue analgesic requirement in the initial 24 hr without significant postoperative adverse effects.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-07-13
• Study Start: 2022-07-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients who are willing to give written informed consent.
• Patients with ASA Grade 1 and 2.
• Patients scheduled for elective laparoscopic cholecystectomy.

Exclusion Criteria

• PATIENT REFUSAL 2.
• ALLERGY TO LOCAL ANESTHETIC DRUGS 3.
• PATIENTS WITH ACUTE PANCREATITIS,CHRONIC PAIN, CHOLEDOCHOLITHIASIS 4.
• PATIENTS WITH CHRONIC OPIOID USE, CHRONIC NSAID USE 5.
• INABILITY TO COMPREHEND VAS 6.
• PATIENTS WITH CONVERSION OF LAPAROSCOPIC CHOLECYSTECTOMY TO OPEN CHOLECYSTECTOMY.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first rescue analgesic	Time to first rescue analgesic

Secondary Outcome Measures

Name	Time	Method
Total rescue analgesic requirement	first 24 hours
Time to Ambulation	First 24 hours
Total episodes of vomiting	first 24 hours
incidence of shoulder pain	first 48 hours

Trial Locations

Locations (1)

Bangalore Medical College And Research Institute; 🇮🇳 Bangalore, KARNATAKA, India

Bangalore Medical College And Research Institute

🇮🇳Bangalore, KARNATAKA, India

DR Divya Shukla

Principal investigator

9945659167

divyashukla17sep@gmail.com