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ACTIVE NOT RECRUITING

NCT06632184

PHASE4

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

Sponsor: Instituto Mexicano del Seguro Social

View on ClinicalTrials.gov

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.

Official title: Pilot Comparative Study on the Efficacy of Multimodal Management With Peritoneal Lavage Using Saline Solution Versus Saline Solution With Ondansetron in Laparoscopic Cholecystectomy

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-12-01

Completion Date

2026-03-31

Last Updated

2025-12-16

Healthy Volunteers

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.

Eligible participants will be adult patients scheduled for elective laparoscopic cholecystectomy at the study site. To ensure a homogeneous sample appropriate for this pilot trial, strict inclusion and exclusion criteria have been defined. Inclusion criteria Patients meeting all the following criteria will be considered for enrollment: 1. Aged between 18 and 60 years. 2. American Society of Anesthesiologist (ASA) physical status classification I or II. 3. Scheduled for elective laparoscopic cholecystectomy due to symptomatic cholelithiasis, resolved choledocholithiasis post-endoscopic retrograde cholangiopancreatography (ERCP), or gallbladder polyp. 4. Placement of a ¾-inch Penrose drain in the subhepatic cavity as part of the standardized surgical technique, to allow evacuation of residual CO2, residual lavage fluid, and close monitoring for possible postoperative bleeding or bile leakage. 5. Intraoperative surgical difficulty assessed as Grade I, II or III according to the Nassar scale 6. Ability to provide written, informed consent Exclusion Criteria Patients presenting with any of the following will be excluded: 1. Confirmed pregnancy or lactation 2. Intraoperative findings of Nassar Grade IV, suspected gallbladder cancer, scleroatrophic gallbladder, or cirrhosis 5\. Use of NSAIDs within 24 hours prior to surgery, or chronic use of NSAIDs, opioids, immunosuppressants, chemotherapy, or anticoagulants. 6\. Known allergies to ondansetron, acetaminophen, diclofenac sodium, buprenorphine or tramadol 7\. Significant cardiac disease (e.g., heart failure, arrhythmias, pacemaker dependency) 8\. Obesity Grade IV (Body Mass Index ≥ 50 kg/m2) 9\. History of recurrent vertigo or motion sickness Elimination Criteria Patients who meet inclusion criteria but experience the following intraoperative events will be eliminated from the final per-protocol analysis: significant bleeding or bile duct injury requiring re-intervention, conversion to open surgery, or a total operative time exceeding 80 minutes.

Locations (1)

General Hospital No. 89 of the Mexican Social Security Institute (IMSS)

Guadalajara, Jalisco, Mexico