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

NCT06632184 | Active Not Recruiting Phase 4 DMC

• 2 other identifiers: F-CNIC-2024-097R-2025-785-080
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Laparoscopic cholecystectomy; Ondansetron Formulations; Intraperitoneal Analgesia; Saline Solution; Pain Management; Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Total Pain Burden as Measured by the Area Under the Curve (AUC) of Visual Analog Scale (VAS) Scores Over the First 24 Postoperative Hours

  The primary outcome is the total burden of postoperative pain, quantified as the Area Under the Curve (AUC) of serial Visual Analog Scale (VAS) scores measured at 0, 2, 6, 12, and 24 hours after surgery. The AUC is calculated using the trapezoidal rule, which integrates both the intensity and duration of pain into a single composite measure (units: mm\*hour). This provides a more comprehensive assessment of the patient's pain experience over the critical first postoperative day than isolated time-point measurements. A lower AUC indicates superior pain control.

  0, 2, 6, 12, and 24 hours postoperatively

Secondary Outcomes (4)

• Incidence of Postoperative Nausea and Vomiting (PONV)

  0, 2, 6, 12, and 24 hours postoperatively

• Use of Rescue Analgesia Within 24 Hours Postoperatively

  0 to 24 hours postoperatively

• Postoperative Sleep Quality Assessed by the Richards-Campbell Sleep Questionnaire

  Night of surgery to morning after surgery

• Incidence of Adverse Events Possibly Related to Intraperitoneal Ondansetron

  0 to 24 hours postoperatively

Study Arms (2)

Saline Lavage Only

ACTIVE COMPARATOR

Participants in this arm will receive intraoperative peritoneal lavage with 500 mL of 0.9% saline solution for 5 minutes at the end of laparoscopic cholecystectomy. The solution will be fully aspirated before abdominal closure. The solution will remain in the peritoneal cavity for 5 minutes and then be completely aspirated before closure. All participants will also receive standard multimodal analgesia including paracetamol, diclofenac, and local wound infiltration with bupivacaine.

Drug: Saline Intraperitoneal Lavage

Saline Lavage With Ondansetron

EXPERIMENTAL

Participants in this arm will undergo peritoneal lavage with 500 mL of 0.9% saline solution combined with 8 mg of ondansetron, administered intraperitoneally at the end of elective laparoscopic cholecystectomy. The solution will remain in the peritoneal cavity for 5 minutes and then be completely aspirated before closure. All participants will also receive standard multimodal analgesia including paracetamol, diclofenac, and local wound infiltration with bupivacaine.

Drug: Ondansetron Intraperitoneal Lavage

Interventions

Saline Intraperitoneal Lavage DRUG

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.

Also known as: normal saline, 0.9% Sodium Chloride, Saline Solution

Saline Lavage Only

Ondansetron Intraperitoneal Lavage DRUG

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.

Also known as: Ondansetron, Zofran, 0.9% Sodium Chloride

Saline Lavage With Ondansetron

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Patients meeting all the following criteria will be considered for enrollment:
• Aged between 18 and 60 years.
• American Society of Anesthesiologist (ASA) physical status classification I or II.
• Scheduled for elective laparoscopic cholecystectomy due to symptomatic cholelithiasis, resolved choledocholithiasis post-endoscopic retrograde cholangiopancreatography (ERCP), or gallbladder polyp.
• 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.
• Intraoperative surgical difficulty assessed as Grade I, II or III according to the Nassar scale
• Ability to provide written, informed consent
• Patients presenting with any of the following will be excluded:
• Confirmed pregnancy or lactation
• Intraoperative findings of Nassar Grade IV, suspected gallbladder cancer, scleroatrophic gallbladder, or cirrhosis
• \. Use of NSAIDs within 24 hours prior to surgery, or chronic use of NSAIDs, opioids, immunosuppressants, chemotherapy, or anticoagulants.
• \. Known allergies to ondansetron, acetaminophen, diclofenac sodium, buprenorphine or tramadol
• \. Significant cardiac disease (e.g., heart failure, arrhythmias, pacemaker dependency)
• \. Obesity Grade IV (Body Mass Index ≥ 50 kg/m2)
• \. History of recurrent vertigo or motion sickness

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

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

Guadalajara, Jalisco, 44190, Mexico

Location

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MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Agnosia

Interventions

Ondansetron; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Francisco Aguilar Espinosa, Dr.

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a triple-blind study. Beyond the participant, the following key parties are masked: the surgeons performing the procedure, the anesthesiologists managing perioperative care, and the post-operative outcome assessors (e.g., research interns collecting pain scores and other clinical data). A designated "blinding coordination nurse," who is not involved in any clinical or assessment roles, prepares the identical-looking solutions according to the randomization sequence. The data analyst will also remain masked to group allocation (coded as A/B) until the completion of the primary statistical analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgery department: Dr. Francisco Aguilar Espinosa, Clinical Research

Model Details: nterventional Study Model: Parallel assignment. Participants are randomized into one of two parallel groups in a 1:1 ratio to receive either the experimental intervention or the control intervention for the duration of the study. The model incorporates triple-blinding (participant, care provider, outcomes assessor) and a randomized, controlled design. Allocation is performed using a computer-generated sequence with permuted blocks, stratified by sex and ASA physical status classification to ensure balanced groups.

Study Record Dates

• First Submitted: October 5, 2024
• First Posted: October 8, 2024
• Study Start: December 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

ME (1)