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Depodur vs Fentanyl Infusion for Post-C/S Analgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00762554
Recruitment Status : Unknown
Verified September 2008 by Goodman, Evan, M.D..
Recruitment status was:  Not yet recruiting
First Posted : September 30, 2008
Last Update Posted : September 30, 2008
Information provided by:
Goodman, Evan, M.D.

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.

Condition or disease Intervention/treatment Phase
Analgesia Drug: Depodur Drug: Fentanyl Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Single Dose Depodur With Fentanyl Infusion for Post-Cesarean Section Analgesia
Study Start Date : October 2008
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Epidural Depodur after epidural lidocaine
Drug: Depodur
Depodur 10mg given epidurally at end of cesarean section.

Active Comparator: 2
Epidural Depodur after spinal bupivacaine
Drug: Depodur
Depodur 10mg given epidurally at end of cesarean section after patient received spinal bupivacaine at the beginning of the case.

Active Comparator: 3
Epidural fentanyl infusion after epidural lidocaine or spinal bupivacaine
Drug: Fentanyl
Epidural fentanyl infusion started after epidural lidocaine or spinal bupivacaine used for the cesarean section.

Primary Outcome Measures :
  1. Degree of analgesia (measured on a 10-point scale) [ Time Frame: 48 hours post-operatively ]

Secondary Outcome Measures :
  1. Frequency of minor side effects, such as pruritis or nausea. [ Time Frame: 48 hours postoperatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00762554

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United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Contact: Evan Goodman, MD    216-844-5300   
Contact: Susan Dumas, MD    2168447330   
Principal Investigator: Evan Goodman, MD         
Sponsors and Collaborators
Goodman, Evan, M.D.
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Responsible Party: Evan Goodman, MD, University Hospitals Case Medical Center Identifier: NCT00762554    
Other Study ID Numbers: goodman-1
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: September 30, 2008
Last Verified: September 2008
Keywords provided by Goodman, Evan, M.D.:
cesarean section
Post-cesarean section analgesia
Additional relevant MeSH terms:
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Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General