Epidural Morphine Versus Epidural Fentanyl Infusion Following Cesarean Section
NCT ID: NCT01362998
Last Updated: 2022-11-14
Study Results
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View full resultsBasic Information
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TERMINATED
NA
2 participants
INTERVENTIONAL
2011-01-31
2012-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Preservative free morphine
This group will receive 3mg of preservative free morphine epidurally during the procedure.
Preservative free morphine
3mg given epidurally during the Cesarean section.
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.
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.
Interventions
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Preservative free morphine
3mg given epidurally during the Cesarean section.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Healthy women (ASA I or II)
* Regional anesthesia candidates
Exclusion Criteria
* Sleep apnea
* Age under 18
* Intolerance or addiction to opioids
18 Years
50 Years
FEMALE
Yes
Sponsors
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Goodman, Evan, M.D.
INDIV
Responsible Party
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Dr. Evan Goodman, MD
Anesthesiologist
Principal Investigators
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Evan Goodman, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center
Locations
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University Hospitals Case Medical Center
Cleveland, Ohio, United States
Countries
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References
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Sarvela J, Halonen P, Soikkeli A, Korttila K. A double-blinded, randomized comparison of intrathecal and epidural morphine for elective cesarean delivery. Anesth Analg. 2002 Aug;95(2):436-40, table of contents. doi: 10.1097/00000539-200208000-00037.
Other Identifiers
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goodman-2
Identifier Type: -
Identifier Source: org_study_id
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