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

Phase 4

Not yet recruiting

• Conditions: Ondansetron; Postoperative Pain Management; Laparoscopic Cholecystectomy; Postoperative Nausea and Vomiting
• Interventions: Drug: Saline Intraperitoneal Lavage; Drug: Ondansetron Intraperitoneal Lavage

• Registration Number: NCT06632184
• Lead Sponsor: Instituto Mexicano del Seguro Social

Brief Summary

This is a pilot clinical trial evaluating whether adding ondansetron to a peritoneal lavage with saline during laparoscopic cholecystectomy can reduce postoperative pain and nausea. Thirty-two adult patients undergoing elective gallbladder removal will be randomly assigned to receive either a standard saline lavage or a saline solution with ondansetron (8 mg) applied directly to the abdominal cavity at the end of surgery. Both groups will receive standard multimodal pain management. The study aims to compare pain levels, incidence of nausea and vomiting, and quality of sleep within the first 24 hours after surgery. Results will help determine if this technique can improve postoperative recovery and patient comfort.

Detailed Description

This study investigates the efficacy and safety of peritoneal lavage with 0.9% saline solution versus 0.9% saline solution with ondansetron in reducing postoperative pain after elective laparoscopic cholecystectomy. The intervention is performed intraoperatively, at the end of the surgical procedure, immediately prior to trocar removal.

Patients meeting inclusion criteria (ASA I-II, symptomatic cholelithiasis, elective laparoscopic cholecystectomy, no drain placement) will be randomized in a double-blind manner into two groups:

Group A (control): Peritoneal lavage with 500 mL of 0.9% saline solution.

Group B (intervention): Peritoneal lavage with 500 mL of 0.9% saline solution containing 8 mg of ondansetron.

The primary outcome is postoperative pain measured using the Visual Analog Scale (VAS) at 2, 6, 12, and 24 hours postoperatively. Secondary outcomes include the requirement for rescue analgesia, quality of sleep assessed with the Richards-Campbell Sleep Questionnaire, and incidence of nausea or vomiting.

The study is conducted at Hospital General de Zona No. 89 (IMSS), with follow-up limited to the immediate postoperative period during hospitalization. Participants are monitored for any adverse effects related to the drug or surgical procedure. Ondansetron is used in a single dose intraperitoneally and has an established safety profile. The study complies with international ethical standards, including the Declaration of Helsinki and CIOMS guidelines.

This is a single-center, randomized, controlled, double-blind clinical trial with two parallel arms. The sample size is calculated for pilot purposes to evaluate feasibility and preliminary effectiveness outcomes.

Study Timeline

• Study First Submitted: 2024-10-05
• Study First Submitted QC: 2024-10-06
• Study First Posted: 2024-10-08
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-16
• Last Update Posted: 2025-06-19
• Study Start: 2025-08-06
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Age ≥ 18 years Diagnosis of symptomatic cholelithiasis Scheduled for elective laparoscopic cholecystectomy ASA Physical Status I-II Ability to understand and sign the informed consent Willingness to comply with study procedures and follow-up

Exclusion Criteria

Emergency or open cholecystectomy Use of intra-abdominal drain at the end of surgery Pregnancy or breastfeeding Allergy or hypersensitivity to ondansetron or related compounds History of prolonged QT interval or current use of QT-prolonging drugs Chronic opioid use or recent use of antiemetic agents Severe hepatic or renal dysfunction Psychiatric, neurological, or communication disorders affecting pain or sleep evaluation Refusal or inability to complete postoperative assessments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline Lavage Only	Saline Intraperitoneal Lavage	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.
Saline Lavage With Ondansetron	Ondansetron Intraperitoneal Lavage	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.

Primary Outcome Measures

Name	Time	Method
Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)	0, 2, 6, 12, and 24 hours postoperatively	Pain intensity will be measured using a 100 mm Visual Analog Scale (VAS), where 0 indicates "no pain" and 100 indicates "worst pain imaginable." Measurements will be taken at 0, 2, 6, 12, and 24 hours after surgery. A reduction in VAS scores indicates lower pain levels.

Secondary Outcome Measures

Name	Time	Method
Use of Rescue Analgesia Within 24 Hours Postoperatively	0 to 24 hours postoperatively	The proportion of patients requiring rescue analgesia (buprenorphine 75 mcg subcutaneously) will be recorded. The time to first dose and the total number of doses will also be analyzed.
Postoperative Sleep Quality Assessed by the Richards-Campbell Sleep Questionnaire	Night of surgery to morning after surgery	Sleep quality will be evaluated using the Richards-Campbell Sleep Questionnaire, which includes six visual analog items rated from 0 to 100. A higher score indicates better sleep. The total average score will be calculated for each participant.
Incidence of Adverse Events Possibly Related to Intraperitoneal Ondansetron	0 to 24 hours postoperatively	Any unexpected clinical signs, symptoms, or laboratory abnormalities that could be associated with the intraperitoneal use of ondansetron will be recorded and evaluated by the study team.
Incidence of Postoperative Nausea and Vomiting (PONV)	0, 2, 6, 12, and 24 hours postoperatively	The presence and number of postoperative nausea and vomiting (PONV)

Trial Locations

Locations (1)

General Hospital No. 89 of the Mexican Social Security Institute (IMSS); 🇲🇽 Guadalajara, Jalisco, Mexico