Depodur vs Fentanyl Infusion for Post-C/S Analgesia

March 14, 2022 updated by: Dr. Evan Goodman, MD, Goodman, Evan, M.D.

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Epidural Depodur after spinal bupivacaine
Drug: Depodur
Depodur 10mg given epidurally at end of cesarean section.
Drug: Depodur
Depodur 10mg given epidurally at end of cesarean section after patient received spinal bupivacaine at the beginning of the case.
Active Comparator: 2
Epidural fentanyl infusion after epidural lidocaine or spinal bupivacaine
Drug: Fentanyl
Epidural fentanyl infusion started after spinal bupivacaine used for the cesarean section.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Degree of analgesia (measured on a 10-point scale)
Time Frame: 48 hours post-operatively
48 hours post-operatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of minor side effects, such as pruritis or nausea.
Time Frame: 48 hours postoperatively
48 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goodman, Evan, M.D.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

September 29, 2008

First Submitted That Met QC Criteria

September 29, 2008

First Posted (Estimate)

September 30, 2008

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • goodman-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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