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Epidural Morphine Versus Epidural Fentanyl Infusion Following Cesarean Section

Not Applicable
Terminated
Conditions
Pain
Interventions
Registration Number
NCT01362998
Lead Sponsor
Goodman, Evan, M.D.
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
Female
Target Recruitment
2
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Preservative free morphinePreservative free morphineThis group will receive 3mg of preservative free morphine epidurally during the procedure.
Fentanyl infusionFentanylThis 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.
Primary Outcome Measures
NameTimeMethod
Postsurgical PainAt 8, 24 36 and 48 hours after the Cesarean section

Participants will be asked to rate their pain on a 10 point Numerical Rating Pain Scale, where zero is no pain and ten is the most intense pain possible.

Secondary Outcome Measures
NameTimeMethod
Number of Participants Who Responded Yes to Having Nausea or VomitingAt 8, 24, 36 and 48 hours after the Cesarean section

The patient will be asked whether she has nausea or vomiting (yes=1, no=0).

Number of Participants Who Were Observed by Their Nurse to Have Urinary RetentionAt 8, 24, 36 and 48 hours after Cesarean section

Participant's nurse will be asked whether \>400ml was obtained by straight cath (Y=1, No=0)

Number of Participants Who Were Observed by Their Nurse to Have Respiratory DepressionAt 8, 24, 36 and 48 hours after the Cesarean section

Participant's chart will be examined to determine whether the respiratory rate was \<8 per minute (Yes=1, No=0)

Patient SatisfactionAt 8, 24, 48 and 36 hours after Cesarean section

Participants will be asked to rate their satisfaction on a 10 point Numerical Rating Scale (0=worst, 10=best).

Number of Participants Who Responded Yes to Having Back PainAt 8, 24, 36 and 48 hours after the Cesarean section

Participants will be asked whether they have back pain (Yes=1, No=0)

Number of Participants Who Responded Yes to Having PruritisAt 8, 24, 36 and 48 hours after Cesarean section

Participants will be asked whether they have pruritis (Yes=1, No=0)

Trial Locations

Locations (1)

University Hospitals Case Medical Center

🇺🇸

Cleveland, Ohio, United States

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