Study Stopped
Uncertain safety of one of the study medications.
Depodur vs Fentanyl Infusion for Post-C/S Analgesia
A Comparison of Single Dose Depodur With Fentanyl Infusion for Post-Cesarean Section Analgesia
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2008
CompletedFirst Posted
Study publicly available on registry
September 30, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedMarch 29, 2022
March 1, 2022
8 months
September 29, 2008
March 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Degree of analgesia (measured on a 10-point scale)
48 hours post-operatively
Secondary Outcomes (1)
Frequency of minor side effects, such as pruritis or nausea.
48 hours postoperatively
Study Arms (2)
1
ACTIVE COMPARATOREpidural Depodur after spinal bupivacaine
2
ACTIVE COMPARATOREpidural fentanyl infusion after epidural lidocaine or spinal bupivacaine
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Related 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.
PMID: 15781537BACKGROUNDCarvalho 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. doi: 10.1213/01.ane.0000265533.13477.26.
PMID: 17578973BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiologist
Study Record Dates
First Submitted
September 29, 2008
First Posted
September 30, 2008
Study Start
October 1, 2008
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
March 29, 2022
Record last verified: 2022-03