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

Launched by INSTITUTO MEXICANO DEL SEGURO SOCIAL · Oct 6, 2024

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ClinConnect Summary

This clinical trial is looking at two different formulations of a medication called ondansetron, which is commonly used to help manage pain and nausea after surgery. The study will involve patients who are scheduled to have a laparoscopic cholecystectomy, a minimally invasive surgery to remove the gallbladder. During the surgery, patients will receive one of two versions of ondansetron—one mixed with a solution of bicarbonate and the other with a saline solution. The main goal is to see which formulation helps reduce pain more effectively in the first 24 hours after surgery. Researchers will also check how often patients need additional pain relief, as well as the levels of nausea and vomiting they experience.

To participate in this study, patients must be between 18 and 60 years old and scheduled for elective surgery. They should be generally healthy, with a few specific medical conditions excluded, such as certain types of lung disease or previous abdominal surgeries. Participants will have the chance to contribute to research that aims to improve pain management after surgery, making recovery easier for future patients. It's important to note that the trial is not yet recruiting participants, so those interested should keep an eye out for updates.

Gender

ALL

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