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NCT00762554 Clinical Trial

Depodur vs Fentanyl Infusion for Post-C/S Analgesia

Analgesia Clinical Trial

Official title:
A Comparison of Single Dose Depodur With Fentanyl Infusion for Post-Cesarean Section Analgesia

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00762554
Other study ID # goodman-1
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 2008
Est. completion date June 2009

Study information
Verified date March 2022
Source Goodman, Evan, M.D.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Epidurally administered Depodur provides equal or superior analgesia as an epidural infusion of fentanyl for the first 48 hours after a cesarean section.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Depodur
Depodur 10mg given epidurally at end of cesarean section.
• Depodur
Depodur 10mg given epidurally at end of cesarean section after patient received spinal bupivacaine at the beginning of the case.
• Fentanyl
Epidural fentanyl infusion started after spinal bupivacaine used for the cesarean section.

Locations
Country Name City State
United States University Hospitals Case Medical Center Cleveland Ohio

Sponsors (1)
Lead Sponsor Collaborator
Goodman, Evan, M.D.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Carvalho B, Riley E, Cohen SE, Gambling D, Palmer C, Huffnagle HJ, Polley L, Muir H, Segal S, Lihou C, Manvelian G; DepoDur 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):1150-1158. doi: 10.1213/01.ANE.0000149544.58230.FF. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Degree of analgesia (measured on a 10-point scale) 48 hours post-operatively
Secondary Frequency of minor side effects, such as pruritis or nausea. 48 hours postoperatively
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