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Using the medicine Ondansetron inside the Abdomen during surgery to help with Pain after Gallbladder Surgery

Intraperitoneal ondansetron for postoperative analgesia in laparoscopic/robotic cholecystectomy : a double-blinded, randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080675
Enrollment
56
Registered
2025-02-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: K802- Calculus of gallbladder without cholecystitis

Interventions

Intervention1: Receiving ondansetron (Group A): Subjects will be administered with 4mg ondansetron (2ml) stat intraperitoneally in the gall bladder bed via irrigation at the end of procedure. Control

Sponsors

Mohd Sharib Wahaj
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients more than 18 years planned for laparoscopic and robotic cholecystectomy.

Exclusion criteria

Exclusion criteria: 1.Patients who have liver or renal dysfunction. 2.Patients who have chronic pain other than symptomatic cholelithiasis. 3.Patients who have history of daily intake of corticosteroids or a history of allergy to any of the study drugs. 4.Patients with communication problems, cognitive dysfunction, or psychological disorders. 5.Patients who received analgesics or sedatives 24 h before a scheduled surgery. 6.All pregnant/lactating females 7.Patients undergoing concomitant surgeries 8.Minimally invasive procedure converted to open procedure

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy in pain relief from baseline to 12, and 24 hours post-operatively in the study populationTimepoint: To evaluate the efficacy in pain relief from baseline to 12, and 24 hours post-operatively in the study population

Secondary

MeasureTime frame
To compare the differences between study groups in Time to first rescue analgesic request Cumulative consumption of rescue analgesic postoperative period till discharge. Time for unassisted mobilization. Timepoint: Cumulative dose of rescue analgesia required in 24 hours, time to first recue analgesia request and time to unassisted mobilization.

Countries

India

Contacts

Public ContactDr Vikram Kate

Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Pondicherry

drvikramkate@gmail.com9843058013

Outcome results

None listed

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