Comparison of intraperitoneal (within the peritoneal cavity) nebulisation of ropivacaine (a local anaestheic) with ropivacaine and fentanyl (a pain killer)for controlling pain after laparoscopic cholecystectomy (gall bladder removal surgery)
Not Applicable
Completed
- Conditions
- Health Condition 1: null- ASA I/II patients coming for laparoscopic cholecystectomy
- Registration Number
- CTRI/2014/08/004810
- Lead Sponsor
- The Director
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 75
Inclusion Criteria
After obtaining written informed consent, 75 ASA I/II patients of both sexes & in the age group of 18-60 years, scheduled to undergo laparoscopic cholecystectomy under general anaesthesia will be enrolled in the study.
Exclusion Criteria
Exclusion criteria will be patients with:
-coexisting disease affecting clinical assessment
-acute preoperative pain other than biliary colic
-chronic pain treatment
-history of substance abuse
-psychiatric illness
-opiate tolerance
-hepatic / renal dysfunction
-coagulopathies
-pregnancy / lactating females
-allergy to any of the drugs used in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome of this study will be the incidence of significant pain (dynamic VAS â?¥30 mm), requiring rescue analgesic, during the first 48 hours after an elective laparoscopic cholecystectomyTimepoint: at PACU admission, 2 h, 4 h, 8 h, 12 h, 24h and at 48 hour interval
- Secondary Outcome Measures
Name Time Method Secondary outcome measures will include postoperative pain intensity at rest and on movement, as measured by visual analogue scale (VAS) scores, presence of postoperative shoulder pain, total opioid consumption in the postoperative period, time to first request for rescue analgesic and side-effects, if any, with the use of study drugs.Timepoint: at PACU admission, 2 h, 4 h, 8 h, 12 h, 24h and at 48 hour interval