Depodur vs Fentanyl Infusion for Post-C/S Analgesia

Not Applicable

Withdrawn

• Conditions: Analgesia
• Interventions: Drug: Fentanyl; Drug: Depodur

• 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

Study Timeline

• Study First Submitted: 2008-09-29
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Study Start: 2008-10
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-29

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• Status: WITHDRAWN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

Trial Locations

Locations (1)

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States