Back to resultsDepodur vs Fentanyl Infusion for Post-C/S Analgesia
Primary Purpose
Analgesia
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Depodur
Depodur
Fentanyl
Sponsored by
About this trial
This is an interventional treatment trial for Analgesia focused on measuring analgesia, cesarean section, fentanyl, Depodur, Post-cesarean section analgesia
Eligibility 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
Sites / Locations
- University Hospitals Case Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Epidural Depodur after spinal bupivacaine
Epidural fentanyl infusion after epidural lidocaine or spinal bupivacaine
Outcomes
Primary Outcome Measures
Degree of analgesia (measured on a 10-point scale)
Secondary Outcome Measures
Frequency of minor side effects, such as pruritis or nausea.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00762554
Brief Title
Depodur vs Fentanyl Infusion for Post-C/S Analgesia
Official Title
A Comparison of Single Dose Depodur With Fentanyl Infusion for Post-Cesarean Section Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Uncertain safety of one of the study medications.
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Goodman, Evan, M.D.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia
Keywords
analgesia, cesarean section, fentanyl, Depodur, Post-cesarean section analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Epidural Depodur after spinal bupivacaine
Arm Title
2
Arm Type
Active Comparator
Arm Description
Epidural fentanyl infusion after epidural lidocaine or spinal bupivacaine
Intervention Type
Drug
Intervention Name(s)
Depodur
Intervention Description
Depodur 10mg given epidurally at end of cesarean section.
Intervention Type
Drug
Intervention Name(s)
Depodur
Intervention Description
Depodur 10mg given epidurally at end of cesarean section after patient received spinal bupivacaine at the beginning of the case.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Epidural fentanyl infusion started after spinal bupivacaine used for the cesarean section.
Primary Outcome Measure Information:
Title
Degree of analgesia (measured on a 10-point scale)
Time Frame
48 hours post-operatively
Secondary Outcome Measure Information:
Title
Frequency of minor side effects, such as pruritis or nausea.
Time Frame
48 hours postoperatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15781537
Citation
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.
Results Reference
background
PubMed Identifier
17578973
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. doi: 10.1213/01.ane.0000265533.13477.26.
Results Reference
background
Learn more about this trial
Depodur vs Fentanyl Infusion for Post-C/S Analgesia
We'll reach out to this number within 24 hrs