Epidural Morphine Versus Epidural Fentanyl Infusion Following Cesarean Section

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Comparison of Single Dose Preservative Free Morphine With Fentanyl Infusion for Post-Cesarean Section Analgesia

Conditions
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Pain

Intervention / Treatment
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* Drug: Preservative free morphine
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Preservative free morphine<br>This group will receive 3mg of preservative free morphine epidurally during the procedure. | Drug: Preservative free morphine<br>* 3mg given epidurally during the Cesarean section.<br>* Other names: Duramorph;|
| Active Comparator: Fentanyl infusion<br>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. | Drug: Fentanyl<br>* An infusion of epidural fentanyl started during the Cesarean section. It will be given on a patient controlled analgesia basis, with a basal rate of 60 micrograms, a demand dose of 16 micrograms, and a lockout of 15 mins.<br>* Other names: PCA fentanyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postsurgical Pain | 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. | At 8, 24 36 and 48 hours after the Cesarean section | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Responded Yes to Having Nausea or Vomiting | The patient will be asked whether she has nausea or vomiting (yes=1, no=0). | At 8, 24, 36 and 48 hours after the Cesarean section | 
| Patient Satisfaction | Participants will be asked to rate their satisfaction on a 10 point Numerical Rating Scale (0=worst, 10=best). | At 8, 24, 48 and 36 hours after Cesarean section | 
| Number of Participants Who Responded Yes to Having Back Pain | Participants will be asked whether they have back pain (Yes=1, No=0) | At 8, 24, 36 and 48 hours after the Cesarean section | 
| Number of Participants Who Responded Yes to Having Pruritis | Participants will be asked whether they have pruritis (Yes=1, No=0) | At 8, 24, 36 and 48 hours after Cesarean section | 
| Number of Participants Who Were Observed by Their Nurse to Have Urinary Retention | Participant's nurse will be asked whether >400ml was obtained by straight cath (Y=1, No=0) | At 8, 24, 36 and 48 hours after Cesarean section | 
| Number of Participants Who Were Observed by Their Nurse to Have Respiratory Depression | Participant's chart will be examined to determine whether the respiratory rate was <8 per minute (Yes=1, No=0) | At 8, 24, 36 and 48 hours after the Cesarean section | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fentanyl, morphine, duramorph, Cesarean section, epidural