Study for comparison of ropivacaine alone versus ropivacaine with nalbuphine for pain relief after laparoscopic cholecystectomy

Phase 3

• Conditions: Health Condition 1: null- Stable: ASA grade 1 &2

• Registration Number: CTRI/2018/09/015764
• Lead Sponsor: AIIMS Rishikesh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Patients aged 18-60 years of either sex

2) Belonging to ASA physical status I and II

3) Planned for laparoscopic cholecystectomy

4) Patients without cognitive impairment or mental retardation.

5) Free from pain in preoperative period.

Exclusion Criteria

Exclusion criteria

1) Refusal by patient for any reason

2) Conversion of laparoscopic approach to open surgery

3) History of alcohol or drug addiction

4) Severe hepatic or renal impairment

5) Allergy to the study drugs

6) Patients with communication problems, cognitive impairment

7) Pregnancy or lactation

8) Chronic pain treatment

9) Anti-epileptic therapy (to avoid confusion with seizures as part of LAST- local anaesthetic systemic toxicity)

10) Patients below 18 years or above 60 years of age

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare the effectiveness on the basis of visual analog pain scale, of intraperitoneally administered: <br/ ><br> Ropivacaine alone against <br/ ><br> Ropivacaine with NalbuphineTimepoint: 2 years

Secondary Outcome Measures

Name	Time	Method
To know the extent of systemic absorption of the drugs administered intraperitoneally, assessed by serum levels of respective drugs. <br/ ><br>To know and compare the incidence and severity of complications of each drug used.Timepoint: 2 years