Pilot Study on the Efficacy of Two Intraperitoneal Ondansetron Formulations for Postoperative Pain Management After Laparoscopic Choleycstectomy.
- Conditions
- OndansetronPostoperative Pain ManagementLaparoscopic CholecystectomyPostoperative Nausea and Vomiting
- Interventions
- Registration Number
- NCT06632184
- Lead Sponsor
- Instituto Mexicano del Seguro Social
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ondansetron with Saline Solution Formulation Ondansetron (ODT) + Saline Solution Participants in this arm will receive an intraperitoneal formulation of ondansetron combined with saline solution during laparoscopic cholecystectomy. This group serves as a comparator to evaluate the effectiveness of the bicarbonate formulation. As with the first arm, the intervention will be administered intraoperatively, and postoperative pain, need for rescue analgesia, and nausea and vomiting will be assessed. Ondansetron with Bicarbonate Formulation Ondansetron (ODT) + Bicarbnate solution Participants in this arm will receive an intraperitoneal formulation of ondansetron combined with bicarbonate during laparoscopic cholecystectomy. The bicarbonate is added to enhance the efficacy of ondansetron in controlling postoperative pain. The intervention will be administered intraoperatively, and the primary outcome measured will be postoperative pain intensity, as well as secondary outcomes such as the need for rescue analgesia and the occurrence of nausea and vomiting.
- Primary Outcome Measures
Name Time Method Postoperative Pain Intensity within 24 hours after surgery 0, 30 minuts, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours postoperatively The primary outcome measure is the intensity of postoperative pain, assessed using the Visual Analog Scale (EVA) and Faces Pain Scale - Revised (FPS-R) within the first 24 hours following laparoscopic cholecystectomy. Pain intensity will be recorded at multiple time points (30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours postoperatively). The EVA score ranges from 0 (no pain) to 10 (worst imaginable pain). The aim is to compare pain levels between the two intervention groups (ondansetron with bicarbonate versus ondansetron with saline) to determine which formulation provides better pain control.
- Secondary Outcome Measures
Name Time Method Need for Rescue Analgesia Within 24 hours after surgery within 24 hours postoperatively, with assessments ar 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours after surgery The secondary outcome measure assesses the need for rescue analgesia within the first 24 hours postoperatively. Rescue analgesia (ketorolac 30 mg i.v.) will be administered if patients report a pain score of ≥70 mm on the Visual Analog Scale (EVA) or ≥6 on Face Pain Scale - Revised (FPS-R). If pain persists despite ketorolac administration, buprenorphine (0.25 ml s.c.) will be given as secondary rescue analgesia. The proportion of patients in each group requiring rescue analgesia will be compared between the two intervention arms (ondansetron with bicarbonate vs. ondansetron with saline).
Trial Locations
- Locations (1)
Hospital General de Zona No. 21, Instituto Mexicano del Seguro Social (IMSS)
🇲🇽Tepatitlan, Jalisco, Mexico