Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632184
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-05
Brief Title:
Pilot Study on the Efficacy of Two Intraperitoneal Ondansetron Formulations for Postoperative Pain Management After Laparoscopic Choleycstectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Pilot Study on the Efficacy of Two Intraperitoneal Ondansetron Formulations for Postoperative Pain After Laparoscopic Cholecystectomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIONFORM
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None