Clinical trial NCT06632184: Pilot Study of Peritoneal Lavage With Saline and Ondansetron in Laparoscopic Cholecystectomy
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Postoperative Pain Management
Laparoscopic Cholecystectomy
Ondansetron
Postoperative Nausea and Vomiting
Keywords: Laparoscopic cholecystectomy
Ondansetron Formulations
Intraperitoneal Analgesia
Saline Solution
Pain Management
Postoperative Nausea and Vomiting
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2024-10-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, parallel-group design comparing peritoneal lavage with saline solution versus saline solution plus ondansetron (8 mg) in patients undergoing elective laparoscopic cholecystectomy. Participants are randomly assigned in a 1:1 ratio.
Primary purpose: TREATMENT

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 randomized, double-blind, controlled pilot trial will evaluate the efficacy of peritoneal lavage with saline solution plus ondansetron (8 mg) versus saline solution alone in patients undergoing elective laparoscopic cholecystectomy. All participants will receive standard multimodal analgesia as recommended by international guidelines. The intervention will be applied intraoperatively at the end of the procedure, followed by suction of the fluid and pneumoperitoneum.

The primary outcome is the intensity of postoperative pain measured using validated scales (Visual Analog Scale and Revised Faces Pain Scale). Secondary outcomes include the incidence of postoperative nausea and vomiting (PONV), time to first rescue analgesia, total analgesic consumption, and sleep quality assessed by the Richards-Campbell Sleep Questionnaire. Safety outcomes and adverse events related to the intraperitoneal administration of ondansetron will also be monitored.

This study will provide preliminary evidence on the effectiveness and safety of intraperitoneal ondansetron as part of a multimodal postoperative pain and PONV management strategy.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)
timeFrame: 0, 2, 6, 12, and 24 hours postoperatively
Secondary outcomes:
measure: Incidence of Postoperative Nausea and Vomiting (PONV)
timeFrame: 0, 2, 6, 12, and 24 hours postoperatively
measure: Use of Rescue Analgesia Within 24 Hours Postoperatively
timeFrame: 0 to 24 hours postoperatively
measure: Postoperative Sleep Quality Assessed by the Richards-Campbell Sleep Questionnaire
timeFrame: Night of surgery to morning after surgery
measure: Incidence of Adverse Events Possibly Related to Intraperitoneal Ondansetron
timeFrame: 0 to 24 hours postoperatively
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: General Hospital No. 89 of the Mexican Social Security Institute (IMSS)
state: Jalisco
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Francisco Aguilar Espinosa, Dr.
role: PRINCIPAL_INVESTIGATOR
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