Depodur vs Fentanyl Infusion for Post-C/S Analgesia
Information source: Goodman, Evan, M.D.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Analgesia
Intervention: Depodur (Drug); Depodur (Drug); Fentanyl (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Goodman, Evan, M.D.
Summary
Epidurally administered Depodur provides equal or superior analgesia as an epidural infusion
of fentanyl for the first 48 hours after a cesarean section.
Clinical Details
Official title: A Comparison of Single Dose Depodur With Fentanyl Infusion for Post-Cesarean Section Analgesia
Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Parallel Assignment, Efficacy Study
Primary outcome: Degree of analgesia (measured on a 10-point scale)
Secondary outcome: Frequency of minor side effects, such as pruritis or nausea.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
University Hospitals Case Medical Center, Cleveland, Ohio 44106, United States
Additional Information
Related publications: Carvalho B, Riley E, Cohen SE, Gambling D, Palmer C, Huffnagle HJ, Polley L, Muir H, Segal S, Lihou C, Manvelian G; DepoSur Study Group. Single-dose, sustained-release epidural morphine in the management of postoperative pain after elective cesarean delivery: results of a multicenter randomized controlled study. Anesth Analg. 2005 Apr;100(4):1150-8. Carvalho B, Roland LM, Chu LF, Campitelli VA 3rd, Riley ET. Single-dose, extended-release epidural morphine (DepoDur) compared to conventional epidural morphine for post-cesarean pain. Anesth Analg. 2007 Jul;105(1):176-83.
Starting date: October 2008
Ending date: June 2009
Last updated: September 29, 2008
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