Clinical trial NCT01362998: Epidural Morphine Versus Epidural Fentanyl Infusion Following Cesarean Section
Official title: A Comparison of Single Dose Preservative Free Morphine With Fentanyl Infusion for Post-Cesarean Section Analgesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Keywords: fentanyl, morphine, duramorph, Cesarean section, epidural
Lead sponsor: Goodman, Evan, M.D.
Sponsor class: INDIV
First posted: 2011-06-01
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Postsurgical Pain
timeFrame: At 8, 24 36 and 48 hours after the Cesarean section
Secondary outcomes:
measure: Number of Participants Who Responded Yes to Having Nausea or Vomiting
timeFrame: At 8, 24, 36 and 48 hours after the Cesarean section
measure: Patient Satisfaction
timeFrame: At 8, 24, 48 and 36 hours after Cesarean section
measure: Number of Participants Who Responded Yes to Having Back Pain
timeFrame: At 8, 24, 36 and 48 hours after the Cesarean section
measure: Number of Participants Who Responded Yes to Having Pruritis
timeFrame: At 8, 24, 36 and 48 hours after Cesarean section
measure: Number of Participants Who Were Observed by Their Nurse to Have Urinary Retention
timeFrame: At 8, 24, 36 and 48 hours after Cesarean section
measure: Number of Participants Who Were Observed by Their Nurse to Have Respiratory Depression
timeFrame: At 8, 24, 36 and 48 hours after the Cesarean section
Other outcomes:
measure: Number of Participants Who Required Additional Pain Medications
timeFrame: At 8, 24, 36 and 48 hours after the Cesarean section
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Evan Goodman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.