Epidural Morphine Versus Epidural Fentanyl Infusion Following Cesarean Section
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|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
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Preservative free morphine Drug: Fentanyl||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
- 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.
- 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.
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
|Contact: Evan Goodman, MDemail@example.com|
|United States, Ohio|
|University Hospitals Case Medical Center||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Evan Goodman, MD 216-844-5300 firstname.lastname@example.org|
|Principal Investigator: Evan Goodman, MD|
|Principal Investigator:||Evan Goodman, MD||University Hospitals Cleveland Medical Center|