Effect of peritoneal local anesthetic plus sedative-analgesics instillation on post-operative pain relief after laparoscopic surgeries.

Completed

• Conditions: Calculus of gallbladder with othercholecystitis,

• Registration Number: CTRI/2019/01/017247
• Lead Sponsor: SVIMS

Brief Summary

Laparoscopic cholecystectomy as compared to open cholecystectomy is currently the most accepted surgical technique for cholelithiasis because of its advantages like lesser haemorrhage, lesser postoperative pain, better cosmetic results and shorter recovery time.The origin of pain after laparoscopic cholecystectomy is multifactorial - incisional pain (somatic pain), visceral pain (deep intra-abdominal pain), and shoulder pain (presumably referred visceral pain).Pain is the dominating complaint which is most intense on the day of surgery and is the primary reason for prolonged convalescence after laparoscopic cholecystectomy. Also, it has been hypothesized that intense acute pain after laparoscopic cholecystectomy may predict development of chronic pain (*e.g.*, post-laparoscopic cholecystectomy syndrome). So, it is an essential task to provide adequate postoperative analgesia.

Of the multimodal methods to control post-operative pain, intraperitoneal instillation of local anaesthetic agents alone or in combination with opioids, alpha�’2 agonists such as clonidineand dexmedetomidine8 blocks the visceral afferent signals and modifies visceral nociception following laparoscopic cholecystectomy. Both clonidine and dexmedetomidine have been tried as adjuvants with local anaesthetics for intraperitoneal infiltration to provide extended period of post operative analgesia.  However, we have not encountered any human study comparing the effects of clonidine versus dexmedetomidine along with bupivacaine for extended post operative analgesia.

The purpose of the present study is to study and compare the efficacy of  antinociceptive effects of intraperitoneal instillation of dexmedetomidine or clonidine added to bupivacaine for providing extended post operative analgesia in patients undergoing laparoscopic cholecystectomy.

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Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-02
• Study Completion: 2019-12-31
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Patients undergoing elective laparoscopic cholecystectomy under general anaesthesia.
• Patients aged 18-60 years.
• Patients of either sex.
• Patients coming under American Society of Anesthesiologists physical status I,II,III.

Exclusion Criteria

• Patients allergic to study drugs.
• Patients with acute cholecystitis.
• Patients with severe cardiac, pulmonary and renal diseases.
• Procedure converted to open cholecystectomy.
• Patients in whom abdominal drain is kept.
• Patients unwilling to participate in the study.
• Pregnant and lactating women.
• Patients who cannot understand or interpret Numerical Rating Scale for pain.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a.Magnitude of pain assessed by Numerical Rating Scale.	pain within 24 hours at different time intervals.

Secondary Outcome Measures

Name	Time	Method
b.Time to first request of analgesia.	c.Analgesic requirement in the first 24 hours post operatively.

Trial Locations

Locations (1)

Sri Venkateswara Institute of Medical Sciences; 🇮🇳 Chittoor, ANDHRA PRADESH, India

Sri Venkateswara Institute of Medical Sciences

🇮🇳Chittoor, ANDHRA PRADESH, India

Aloka Samantaray

Principal investigator

9493547653

aloksvims@gmail.com