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Epidural Morphine Versus Epidural Fentanyl Infusion Following Cesarean Section

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.
 
ClinicalTrials.gov Identifier: NCT01362998
Recruitment Status : Unknown
Verified May 2011 by Goodman, Evan, M.D..
Recruitment status was:  Recruiting
First Posted : June 1, 2011
Last Update Posted : June 1, 2011
Sponsor:
Information provided by:
Goodman, Evan, M.D.

Brief Summary:
For post-Cesarean analgesia, the investigators will compare the efficacy of single-shot epidural preservative free morphine with a continuous epidural fentanyl infusion. The investigators will be comparing the patient's pain level and satisfaction with the two techniques, as well as the side effects that the patients experience, such as itching, nausea, back pain and respiratory depression.

Condition or disease Intervention/treatment Phase
Pain Drug: Preservative free morphine Drug: Fentanyl Not Applicable

Detailed Description:

Included in the study will be all healthy (ASA I or II) woman having elective Cesarean sections who are candidates for regional anesthesia. Exclusion criteria include morbid obesity (BMI > 40), age less that 18 years, history of sleep apnea, and abuse of or intolerance to opioid analgesics.

All patients will also receive 100 micrograms of fentanyl once epidurally during the Cesarean section, and they will receive ibuprofen every six hours for the first 24 hours after the Cesarean section. The patients will be visited twice a day postoperatively for two days. The epidural morphine will be expected to last only approximately 20 hours, while the fentanyl infusion will be kept in place for two days after the procedure. Additional analgesics, such as intravenous morphine or PO oxycodone and tylenol, will be available for breakthrough pain.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Single Dose Preservative Free Morphine With Fentanyl Infusion for Post-Cesarean Section Analgesia
Study Start Date : March 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Preservative free morphine
This group will receive 3mg of preservative free morphine epidurally during the procedure.
Drug: Preservative free morphine
3mg given epidurally during the Cesarean section.
Other Name: Duramorph

Active Comparator: Fentanyl infusion
This group will receive an epidural infusion of fentanyl (60 micrograms per hour), which will be started during the Cesarean section and which will continue for the next two days.
Drug: Fentanyl
An infusion of epidural fentanyl started during the Cesarean section. It will be given on a patient controlled analgesia basis, with a basal rate of 60 micrograms, a demand dose of 16 micrograms, and a lockout of 15 mins.
Other Name: PCA fentanyl




Primary Outcome Measures :
  1. Postsurgical pain [ Time Frame: During the 48 hours after Cesarean section ]
    Participants will be asked to rate their pain on a 10 point visual analog scale.


Secondary Outcome Measures :
  1. Nausea [ Time Frame: During the first 48 hours after Cesarean section ]
    The patient will be asked whether she has nausea, and if so, whether it is mild, moderate or severe. It will also be noted from the nurse's notes whether the patient received any maedication for the nausea.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients having an elective Cesarean section
  • Healthy women (ASA I or II)
  • Regional anesthesia candidates

Exclusion Criteria:

  • Morbid obesity (BMI>40)
  • Sleep apnea
  • Age under 18
  • Intolerance or addiction to opioids

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 ClinicalTrials.gov identifier (NCT number): NCT01362998


Contacts
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Contact: Evan Goodman, MD 2168445300 evan.goodman@uhhospitals.org

Locations
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United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Evan Goodman, MD    216-844-5300    evan.goodman@uhhospitals.org   
Principal Investigator: Evan Goodman, MD         
Sponsors and Collaborators
Goodman, Evan, M.D.
Investigators
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Principal Investigator: Evan Goodman, MD University Hospitals Cleveland Medical Center
Publications:
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Responsible Party: Evan Goodman, M.D., University Hospitals Case Medical Center
ClinicalTrials.gov Identifier: NCT01362998    
Other Study ID Numbers: goodman-2
First Posted: June 1, 2011    Key Record Dates
Last Update Posted: June 1, 2011
Last Verified: May 2011
Keywords provided by Goodman, Evan, M.D.:
fentanyl, morphine, duramorph, Cesarean section, epidural
Additional relevant MeSH terms:
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Fentanyl
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics