Epidural Morphine Versus Epidural Fentanyl Infusion Following Cesarean Section

Goodman, Evan, M.D.

Status: Terminated

Conditions: Pain

Treatments: Drug: Fentanyl; Drug: Preservative free morphine

Study type: Interventional

Identifiers

NCT01362998

goodman-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Preservative free morphine

Active Comparator group

Description:

This group will receive 3mg of preservative free morphine epidurally during the procedure.

Treatment:

Drug: Preservative free morphine

Fentanyl infusion

Active Comparator group

Description:

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.

Treatment:

Drug: Fentanyl