Pilot Study on the Efficacy of Two Intraperitoneal Ondansetron Formulations for Postoperative Pain Management After Laparoscopic Choleycstectomy.

This study is a randomized pilot trial designed to evaluate the efficacy of two different intraperitoneal formulations of ondansetron in managing postoperative pain following laparoscopic cholecystectomy. Patients undergoing this procedure will receive one of two formulations of ondansetron, either combined with bicarbonate or a saline solution, during surgery. The primary objective is to determine which formulation more effectively reduces pain in the first 24 hours post-surgery. Secondary outcomes include the need for rescue analgesics, the frequency of nausea and vomiting, and the safety profile of the interventions. This study aims to improve postoperative pain management and reduce the need for additional pain medications.

This randomized pilot study aims to evaluate the efficacy of two intraperitoneal formulations of ondansetron for managing postoperative pain following laparoscopic cholecystectomy. The two formulations being compared are ondansetron combined with bicarbonate versus ondansetron in a saline solution. The study will involve patients undergoing laparoscopic cholecystectomy, a minimally invasive surgery for gallbladder removal.

The primary goal is to assess the difference in pain control between the two formulations over the first 24 hours post-surgery, as measured by the Visual Analog Scale (EVA) or the Chernick Scale. Patients who report intense pain (EVA ≥ 70 mm or Chernick ≥ 6) will receive ketorolac as a rescue analgesic, and if pain persists, buprenorphine will be used as a secondary analgesic.

Secondary outcomes include the need for rescue analgesia, measured as the use of additional ketorolac or buprenorphine if pain persists. The study will also assess the frequency and severity of postoperative nausea and vomiting (PONV), as ondansetron is known for its antiemetic properties.

The study is designed to explore potential interactions between covariates such as age, sex, body mass index (BMI), and duration of surgery, with the goal of determining whether the effect of the treatment varies according to these factors. Multiple regression models will be employed to analyze these interactions, and both linear and logistic regression techniques will be applied based on the nature of the data.

This research seeks to provide valuable insights into optimizing postoperative pain management after laparoscopic cholecystectomy, potentially reducing the need for additional pain medications and improving patient outcomes. It also aims to further investigate the safety and efficacy profile of intraperitoneal ondansetron, offering a new approach to enhancing recovery in surgical patients.

Eligibility Criteria:
Inclusion Criteria

* Age 18 to 60 years, both genders
* American Society of Anesthesiologists (ASA) Classification 1 or 2
* Scheduled or elective surgery
* Elective laparoscopic cholecystectomy for medical indications, including symptomatic cholelithiasis, resolved choledocholithiasis after endoscopic retrograde cholangiopancreatography (ERCP), gallbladder polyps, or biliary dyskinesia
* Nassar surgical difficulty scale Grade 1 to Grade 2
* Willing to participate and sign informed consent for the study Exclusion Criteria
* Need for postoperative drain placement
* Previous surgery in the supraumbilical abdominal region
* Pregnancy
* Chronic obstructive pulmonary disease (COPD) or bronchial asthma
* Nassar Grade ≥ 3, suspected gallbladder cancer, porcelain or sclerotic gallbladder, hepatic cirrhosis, or biliary pancreatitis
* Use of NSAIDs within 24 hours before surgery, chronic use of NSAIDs/opioids, immunosuppressants, chemotherapy, or anticoagulants
* Allergies to Ondansetron, Acetaminophen, Ketorolac or Sodium Bicarbonate
* Uncontrolled diabetes (HbA1c ≥ 8%)
* Heart failure, arrhythmias, pacemaker
* Vertigo, motion sickness
* Grade IV obesity (body mass index greater than 50 kg/m² Elimination Criteria
* Intraoperative complications such as bleeding or bile duct injury requiring reintervention
* Surgery duration exceeding 60 minutes
* Conversion to open surgery
* Incidental bile leakage greater than 100 ml