Depodur vs Fentanyl Infusion for Post-C/S Analgesia
- Registration Number
- NCT00762554
- Lead Sponsor
- Goodman, Evan, M.D.
- Brief Summary
Epidurally administered Depodur provides equal or superior analgesia as an epidural infusion of fentanyl for the first 48 hours after a cesarean section.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
- Healthy pregnant women (ASA I or II) who are scheduled for an elective cesarean section
- Patient appropriate for regional anesthesia
- Patient agrees to receive regional anesthesia
- Patient willing to have an epidural infusion of medication for two days postoperatively
Exclusion Criteria
- Morbid obesity
- History of sleep apnea
- Allergy to opioids medications
- History of opioids use during week prior to procedure
- Emergency cesarean section
- Significant surgical complications
- Contraindication or refusal to have regional anesthesia
- Age less than 18
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Fentanyl Epidural fentanyl infusion after epidural lidocaine or spinal bupivacaine 1 Depodur Epidural Depodur after spinal bupivacaine
- Primary Outcome Measures
Name Time Method Degree of analgesia (measured on a 10-point scale) 48 hours post-operatively
- Secondary Outcome Measures
Name Time Method Frequency of minor side effects, such as pruritis or nausea. 48 hours postoperatively
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which Depodur provides prolonged analgesia compared to fentanyl infusions post-cesarean section?
How does the efficacy of epidural Depodur compare to standard-of-care fentanyl infusion in postpartum pain management?
Are there specific biomarkers that can predict patient response to epidural Depodur versus fentanyl infusion after cesarean delivery?
What are the potential adverse events associated with epidural Depodur administration in post-cesarean analgesia and how are they managed?
What other long-acting opioid formulations or combination therapies are being explored for postpartum analgesia alongside Depodur and fentanyl?
Trial Locations
- Locations (1)
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
University Hospitals Case Medical Center🇺🇸Cleveland, Ohio, United States