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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


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.


Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.


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

Page last updated: August 23, 2015

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