Trial record 8 of 554 for:    Open Studies | "Pain Management"

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
Sponsor:
Information provided by:
Goodman, Evan, M.D.
ClinicalTrials.gov Identifier:
NCT00762554
First received: September 29, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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:
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 16, 2014