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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)

Comparison of intraperitoneal nebulisation of ropivacaine with ropivacaine-fentanyl combination for pain control following laparoscopic cholecystectomy : A randomized, double-blind, placebo controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/08/004810
Enrollment
75
Registered
2014-08-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- ASA I/II patients coming for laparoscopic cholecystectomy

Interventions

Intervention1: Ropivacaine: Patients in group II will receive intraperitoneal nebulisation using 4ml of 0.75% ropivacaine (3mg) with 2ml of normal saline Intervention2: Ropivacaine and Fentanyl co

Sponsors

The Director
Lead Sponsor

Eligibility

Inclusion criteria

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: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

India

Contacts

Public ContactNidhi Bhatia

PGIMER, Chandigarh, India

nidhi.bhatia75@gmail.com9914207483

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026