Peritoneal Lavage Using Saline or Saline With Ondansetron for Pain Control After Laparoscopic Cholecystectomy

Summary

Brief Summary Background: Laparoscopic cholecystectomy is a common procedure where postoperative pain and nausea/vomiting (PONV) remain significant issues, impairing recovery. Standardized multimodal analgesia (e.g., PROSPECT guidelines) is effective for pain, but PONV incidence stays high. Preliminary evidence suggests that adding ondansetron to the standard intraperitoneal saline lavage could provide additional analgesic and antiemetic benefits by blocking peripheral 5-HT3 receptors at the trauma site.

Objective: This pilot study aims to evaluate if intraperitoneal lavage with saline + 8mg ondansetron reduces the total burden of postoperative pain over the first 24 hours (Area Under the Curve of the Visual Analog Scale, AUC-VAS/24h) compared to saline lavage alone, within a standardized multimodal protocol.

Methods: This is a phase IV, pilot, randomized, controlled, triple-blind clinical trial. 40 adult patients (ASA I-II) undergoing elective laparoscopic cholecystectomy for symptomatic cholelithiasis (Nassar Grade I-II difficulty) will be randomly assigned (1:1) to:

Control Group: 500 ml of 0.9% saline intraperitoneal lavage.

Intervention Group: 500 ml of 0.9% saline + 8 mg ondansetron intraperitoneal lavage.

The lavage is performed for 5 minutes at the end of surgery, followed by complete aspiration. All patients receive a strict multimodal perioperative protocol, including pre-incisional port site infiltration with bupivacaine 0.75%, standardized anesthesia, and postoperative analgesics. The use of intravenous ondansetron is prohibited to avoid confounding.

Primary Outcome: Total postoperative pain burden (AUC-VAS/24h). Secondary Outcomes (Exploratory): PONV incidence; time to first rescue analgesia; rescue analgesic consumption (buprenorphine); postoperative sleep quality (Richards-Campbell Sleep Questionnaire); safety and adverse events.

Conditions

• Postoperative Pain Management
• Laparoscopic Cholecystectomy
• Ondansetron
• Postoperative Nausea and Vomiting

Interventions

DRUG

Ondansetron Intraperitoneal Lavage

A single dose of 8 mg of ondansetron diluted in 500 mL of 0.9% saline solution will be administered as an intraperitoneal lavage at the end of elective laparoscopic cholecystectomy. The solution will remain in the abdominal cavity for 5 minutes and then be fully aspirated before surgical closure. This intervention aims to evaluate the local analgesic and antiemetic effects of ondansetron when used via the peritoneal route.

DRUG

Saline Intraperitoneal Lavage

At the end of elective laparoscopic cholecystectomy, a peritoneal lavage will be performed using 500 mL of 0.9% saline solution (normal saline). The solution will be maintained in the peritoneal cavity for 5 minutes and then fully aspirated before surgical closure. This intervention serves as the comparator to assess the added effect of ondansetron in the experimental group.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social

  lead OTHER_GOV

Principal Investigators

• Francisco Aguilar Espinosa, Dr. · Instituto Mexicano del Seguro Social

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-01

Primary Completion

2026-03-31

Completion

2026-03-31

Countries

• Mexico

Study Locations