Analgesia
Conditions
Keywords
analgesia, cesarean section, fentanyl, Depodur, Post-cesarean section analgesia
Brief summary
Epidurally administered Depodur provides equal or superior analgesia as an epidural infusion of fentanyl for the first 48 hours after a cesarean section.
Interventions
DRUGDepodur
Depodur 10mg given epidurally at end of cesarean section.
DRUGFentanyl
Epidural fentanyl infusion started after spinal bupivacaine used for the cesarean section.
Sponsors
Goodman, Evan, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy pregnant women (ASA I or II) who are scheduled for an elective cesarean section * Patient appropriate for regional anesthesia * Patient agrees to receive regional anesthesia * Patient willing to have an epidural infusion of medication for two days postoperatively
Exclusion criteria
* Morbid obesity * History of sleep apnea * Allergy to opioids medications * History of opioids use during week prior to procedure * Emergency cesarean section * Significant surgical complications * Contraindication or refusal to have regional anesthesia * Age less than 18
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degree of analgesia (measured on a 10-point scale) | 48 hours post-operatively |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of minor side effects, such as pruritis or nausea. | 48 hours postoperatively |
Countries
United States
Outcome results
None listed