To compare the analgesic efficacy of local anesthetic bupivacaine when combined with fentanyl or dexmeditomidine in laproscopic cholecystectomy

Phase 4

Completed

• Conditions: Cholecystitis, unspecified, Symptomatic Cholecystitis and Cholelithiasis posted for Laparoscopic Cholecystectomy,

• Registration Number: CTRI/2019/07/020466
• Lead Sponsor: Dr Sudarshan Kumar

Brief Summary

Laparoscopiccholecystectomy is currently the most accepted surgical technique forcholelithiasis as compared to opencholecystectomy.1 Laparoscopic procedures have many advantages overopen procedures such as lesser haemorrhage, better cosmetic results, lesserpostoperative pain and shorter recovery time leading to shorter hospital stayand less expenditure.2Laparoscopiccholecystectomy would appear to be an ideal operation for ambulatory surgerybecause of short duration, small surgical incisions, a low rate of immediatecomplications and  maintenance ofgastrointestinal homeostasis.3

Painin laparoscopic surgery results from stretching of the intraabdominal cavity,4peritoneal inflammation, and diaphragmatic irritation caused by residualcarbon‑dioxide in the peritonealcavity.5 A single agent is unlikely to treat all three types of painand a multimodal approach will be required to alleviate the pain. Hence manymethods have been proposed to relieve postoperative pain following laparoscopiccholecystectomy.6

Asa part of multimodal analgesic regimen, opioids have always remained as thepreferred agent. However, the use of opioids can result in significant adverseeffects including sedation, nausea, vomiting and respiratory depression thusdelaying early ambulation of patients. Therefore, alternative approaches whichreduce the requirement of strong opioids postoperatively are required. Drugslike paracetamol, diclofenac and COX-2 inhibitors, may not meet allrequirements of post-surgical patients.

Intraperitonealinstillation of local anaesthetic agents has become an important method tocontrol postoperative pain, nausea, vomiting and reduced hospital stay.7,8Intraperitoneal instillation of local anaesthetic agents alone6or in combination with opioids,9,10 ∠2 agonists such as clonidine11,dexmedetomidine9have been found to reduce post‑operativepain following laparoscopic cholecystectomy.

Thelocal anaesthetic agents provide antinociception by affecting nerve membraneassociated proteins and by inhibiting the release and action of prostaglandinswhich stimulates the nociceptors and cause inflammation.12

Thereare very few studies in literature which have examined the analgesic effects ofα 2 agonistsintraperitoneally. The antinociceptive effects of dexmedetomidine occur atdorsal root neuron level, where it blocks the release of substance P in thenociceptive pathway and through action on inhibitory G protein, which increasesthe conductance through potassium channels.13

Fentanylis a potent, synthetic opioid pain medication with a rapid onset and shortduration of action. It is a strong agonist at the μ-opioid receptors. Fentanylis 50 to 100 times more potent than morphine. Despite being a more potentanalgesic, fentanyl tends to induce less nausea, as well as lesshistamine-mediated itching, in relation to morphine.

Sincethere are a few studies which have compared the nociceptive effects ofintraperitoneal fentanyl to intraperitoneal dexmedetomidine, we have proposed astudy to compare the effects of combination of intraperitoneal  dexmedetomidine and bupivacaine to intraperitoneal fentanyl andbupivacaine and to intraperitoneal bupivacaine alone in patients undergoingambulatory laparoscopic cholecystectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-08
• Study Completion: 2018-07-16
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

ASA physical status I and II, who have to undergo ambulatory laparoscopic cholecystectomy for symptomatic cholecystitis and cholelithiasis.

Exclusion Criteria

• BMI less than 18 or > 30 2.
• Patients who are converted into open cholecystectomy 3.
• Patients who have bleeding liver bed 4.
• Psychiatric patient 5.
• Patients who have coagulation disorder 6.
• Patients who have allergy to local anaesthetics, dexmedetomidine or fentanyl 7.
• Patients in whom the drains are to be kept postoperatively.
• Patients of heart block or those having heart rate less than 50.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the recovery profile of patients undergoing ambulatory laparoscopic cholecystectomy	The time 0 starts when patient is shifted to PACU, | 1, 2, 4, 6 hours interval after surgery

Secondary Outcome Measures

Name	Time	Method
To assess postoperative analgesia, requirement of rescue analgesia, haemodynamic stability and other side effects	The time 0 starts when patient is shifted to PACU,

Trial Locations

Locations (1)

Dr. Rajendra Prasad Government Medical College; 🇮🇳 Kangra, HIMACHAL PRADESH, India

Dr. Rajendra Prasad Government Medical College

🇮🇳Kangra, HIMACHAL PRADESH, India

Ripudaman Singh

Principal investigator

9816766170

jelly310@hotmail.co.uk