A study to compare the effectiveness of administering ketamine, levo-bupivacaine and a combination of both into the abdominal cavity for reducing post surgical pain in patients after keyhole surgery for gall bladder removal

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2019/07/019969
• Lead Sponsor: Amala Institute of Medical Sciences

Brief Summary

Pain is a consistent and predominant complaint of many individuals after surgical interventions.Failure to relieve pain is morally and ethically unacceptable.Laparoscopic cholecystectomy has improved surgical outcome in terms of reduced pain,morbidity and duration of convalescence compared to open cholecystectomy.However laparoscopic cholecystectomy is not entirely a pain free procedure.Hence, in this prospective, randomized, double-blind clinical trail we are evaluating and comparing the efficacy of intraperitoneally instilled ketamine,levo-bupivacaine and its combination in alleviating post operative pain after laparoscopic cholecystectomy.

The primary objective of the study is to evaluate and compare the effectiveness of the study drugs in reducing total analgesic consumption for 24 hours post operatively. The secondary objective is to assess reduction in post op pain scores, time to first requirement of rescue analgesia, time to unassisted ambulation and tolerability of the used study drugs represented by side effects during the first 24 hours post operatively.Static pain (at rest) and Dynamic pain (deep breathing) will be assessed at 6, 12 and 24 hours post operatively using a Numerical Rating Scale (NRS).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-07
• Last Update Posted: 2019-06-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Patients of either sex,between age 18 years-70years,ASA physical status 1-3,who are scheduled for laparoscopic cholecystectomy under General Anesthesia and are willing and able to give informed consent will be recruited to the trial.

Exclusion Criteria

Patients were excluded if 1.they had a clinical diagnosis of acute pancreatitis 2.acute preoperative pain other than biliary colic 3.chronic pain treatment 4.anti-epileptic therapy 5.history of alcohol or drug addiction 6.severe hepatic or renal impairment 7.allergy to the study drugs 8.cognitive impairment or communication problems 9.pregnant or lactating 10.conversion to open cholecystectomy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
24 hour total rescue analgesic (diclofenac +/-tramadol) consumption	at 24 hours post operatively

Secondary Outcome Measures

Name	Time	Method
Reduction of postoperative pain scores,Time to first requirement of rescue analgesia, time to unassisted ambulation and Tolerability of the used doses represented by the side effects.	At 6h 12h and 24 hours post operatively

Trial Locations

Locations (1)

Amala Institute of Medical Sciences; 🇮🇳 Thrissur, KERALA, India

Amala Institute of Medical Sciences

🇮🇳Thrissur, KERALA, India

Dr Derlin Thomas

Principal investigator

09447768944

derlin.t@gmail.com