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Patients undergoing laparoscopic surgery for gall bladder stone or other gall bladder diseases will be divided into three groups and given ropivacaine or ropivacaine+dexmedetomidine or normal saline through nebulization in the peritoneum to compare their effect in controlling pain after surgery.

Comparison of intraperitoneal nebulization of ropivacaine with ropivacaine-dexmedetomidine for pain management after laparoscopic cholecystectomy: A randomized double blind, placebo-controlled study. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/066721
Enrollment
84
Registered
2024-05-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: K801- Calculus of gallbladder with othercholecystitis Health Condition 2: K801- Calculus of gallbladder with othercholecystitis

Interventions

Intervention1: Intraperitoneal nebulization with Ropivacaine-dexmedetomidine: 4.5ml of 0.5% ropivacaine plus 1mcg/kg dexmedetomidine made up to total volume of 6ml is used for intraperitoneal nebuliza

Sponsors

Rajendra Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a) The patient giving written and informed consent for study. b) Patients posted for elective laparoscopic cholecystectomy. c) Patients with ASA grade I and II. d) Male and female patients aged between 18-70 years.

Exclusion criteria

Exclusion criteria: a. Patients having a clinical diagnosis of acute pancreatitis. b. Patients having acute preoperative pain other than biliary colic. c. Patients undergoing chronic pain treatment or on anti-epileptic. therapy. d. Patients with severe renal or hepatic impairment. e. Patients with history of alcohol or drug addiction. f. Patients having allergy to the study drugs. g. Patients with cognitive impairment or communication problems. h. Pregnant or lactating patients.

Design outcomes

Primary

MeasureTime frame
To record the time of requirement of first rescue analgesic.Timepoint: Visual Analogue Scale Score 3hours post-surgery 6hours post-surgery 12hours post-surgery 24hours post-surgery

Secondary

MeasureTime frame
a) To record the hemodynamic parameters- systolic blood pressure, diastolic blood pressure, heart rate and MAP every after intraperitoneal nebulization till the end of surgery. b) To record incidence of nausea and vomiting after the operative procedure to the requirement of first rescue analgesic.Timepoint: Baseline 5minutes after nebulization 10minutes after nebulization 15minutes after nebulization 30minutes after nebulization 45minutes after nebulization 60minutes after nebulization 75minutes after nebulization 90minutes after nebulization 105minutes after nebulization

Countries

India

Contacts

Public ContactDr Priyanka Shrivastava

RAJENDRA INSTITUTE OF MEDICAL SCIENCES

shiopriye@gmail.com9986743162

Outcome results

None listed

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