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

A Prospective Comparative Study to Evaluate the Efficacy of Intraperitoneal Nebulisation with Ropivacaine versus Ropivacaine and Nalbuphine for Postoperative Analgesia in Laparoscopic Cholecystectomy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/09/015764
Enrollment
60
Registered
2018-09-19
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- Stable: ASA grade 1 &2

Interventions

Intervention1: Ropivacaine with Nalbuphine : Ropivacaine with saline Versus Ropivacaine with Nalbuphine. Ropivacaine with saline to act as control, to give analgesia to all patients involved in trial.

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

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: 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

Design outcomes

Primary

MeasureTime frame
Compare the effectiveness on the basis of visual analog pain scale, of intraperitoneally administered: Ropivacaine alone against Ropivacaine with NalbuphineTimepoint: 2 years

Secondary

MeasureTime frame
To know the extent of systemic absorption of the drugs administered intraperitoneally, assessed by serum levels of respective drugs. To know and compare the incidence and severity of complications of each drug used.Timepoint: 2 years

Countries

India

Contacts

Public ContactAbullais Raheeq Gowda

AIIMS Rishikesh

abullaisg@gmail.com8880969017

Outcome results

None listed

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