Epidural Morphine Versus Epidural Fentanyl Infusion Following Cesarean Section
Information source: Goodman, Evan, M.D.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Preservative free morphine (Drug); Fentanyl (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Goodman, Evan, M.D. Official(s) and/or principal investigator(s): Evan Goodman, MD, Principal Investigator, Affiliation: University Hospital Case Medical Center
Overall contact: Evan Goodman, MD, Phone: 2168445300, Email: evan.goodman@uhhospitals.org
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.
Clinical Details
Official title: A Comparison of Single Dose Preservative Free Morphine With Fentanyl Infusion for Post-Cesarean Section Analgesia
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Postsurgical pain
Secondary outcome: Nausea
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
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
Locations and Contacts
Evan Goodman, MD, Phone: 2168445300, Email: evan.goodman@uhhospitals.org
University Hospitals Case Medical Center, Cleveland, Ohio 44106, United States; Recruiting Evan Goodman, MD, Phone: 216-844-5300, Email: evan.goodman@uhhospitals.org Evan Goodman, MD, Principal Investigator
Additional Information
Related publications: 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.
Starting date: March 2011
Last updated: May 31, 2011
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