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WithdrawnNCT00762554Updated Mar 29, 2022

Depodur vs Fentanyl Infusion for Post-C/S Analgesia

An interventional study of Depodur and Depodur in Analgesia, sponsored by Goodman, Evan, M.D.. Withdrawn at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-29.

Sponsored by Goodman, Evan, M.D. · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Uncertain safety of one of the study medications.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Analgesia

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Keywords

  • analgesia
  • cesarean section
  • fentanyl
  • Depodur
  • Post-cesarean section analgesia
03

In context

Agnosia

1,269 studies on the registry are indexed under Agnosia; 524 are open to participants now.

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Lead sponsor

Goodman, Evan, M.D. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    1

    Epidural Depodur after spinal bupivacaine

    Drug: Depodur

  • Active comparator
    2

    Epidural fentanyl infusion after epidural lidocaine or spinal bupivacaine

    Drug: Fentanyl

Interventions

  • DrugDepodur

    Depodur 10mg given epidurally at end of cesarean section.

  • DrugDepodur

    Depodur 10mg given epidurally at end of cesarean section after patient received spinal bupivacaine at the beginning of the case.

  • DrugFentanyl

    Epidural fentanyl infusion started after spinal bupivacaine used for the cesarean section.

06

What researchers measure

Primary outcomes

  1. Degree of analgesia (measured on a 10-point scale)

    Time frame: 48 hours post-operatively

Secondary outcomes

  1. Frequency of minor side effects, such as pruritis or nausea.

    Time frame: 48 hours postoperatively

07

Study locations

1 site
  • University Hospitals Case Medical Center
    Cleveland, Ohio 44106, United States
08

References and documents

Publications

  • 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. PubMed 15781537 ↗
  • 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. PubMed 17578973 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00762554
Lead sponsor
Goodman, Evan, M.D.
Responsible party
Dr. Evan Goodman, MD (Anesthesiologist, Goodman, Evan, M.D.) — Principal investigator
First posted
Sep 30, 2008
Start date
Oct 2008
Primary completion
Jun 2009
Completion
Jun 2009
Last update
Mar 29, 2022

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Morphine · Fentanyl

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