Depodur vs Fentanyl Infusion for Post-C/S Analgesia

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2008 by Goodman, Evan, M.D.. Recruitment status was Not yet recruiting

First Received on September 29, 2008. No Changes Posted

Sponsor:	Goodman, Evan, M.D.
Information provided by:	Goodman, Evan, M.D.
ClinicalTrials.gov Identifier:	NCT00762554

Purpose

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

Condition	Intervention
Analgesia	Drug: Depodur Drug: Fentanyl

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Comparison of Single Dose Depodur With Fentanyl Infusion for Post-Cesarean Section Analgesia

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section

Drug Information available for: Bupivacaine hydrochloride Bupivacaine Fentanyl Fentanyl Citrate

U.S. FDA Resources

Further study details as provided by Goodman, Evan, M.D.:

Primary Outcome Measures:

Degree of analgesia (measured on a 10-point scale) [ Time Frame: 48 hours post-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Frequency of minor side effects, such as pruritis or nausea. [ Time Frame: 48 hours postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	October 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762554

Locations

United States, Ohio
University Hospitals Case Medical Center	Not yet recruiting
Cleveland, Ohio, United States, 44106
Contact: Evan Goodman, MD 216-844-5300 evan.goodman@uhhospitals.org
Contact: Susan Dumas, MD 2168447330 susan.dumas@uhhospitals.org
Principal Investigator: Evan Goodman, MD

Sponsors and Collaborators

Goodman, Evan, M.D.

More Information

Publications:

Carvalho B, Riley E, Cohen SE, Gambling D, Palmer C, Huffnagle HJ, Polley L, Muir H, Segal S, Lihou C, Manvelian G; DepoSur 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):1150-8.

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.

Responsible Party:	Evan Goodman, MD, University Hospitals Case Medical Center
ClinicalTrials.gov Identifier:	NCT00762554 History of Changes
Other Study ID Numbers:	goodman-1
Study First Received:	September 29, 2008
Last Updated:	September 29, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Goodman, Evan, M.D.:

analgesia
cesarean section
fentanyl
Depodur
Post-cesarean section analgesia

Additional relevant MeSH terms:

Bupivacaine
Fentanyl
Morphine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents

Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Narcotics
Analgesics
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 09, 2012