Depodur vs Fentanyl Infusion for Post-C/S Analgesia

Goodman, Evan, M.D.

Overview

Epidurally administered Depodur provides equal or superior analgesia as an epidural infusion of fentanyl for the first 48 hours after a cesarean section.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Analgesia

Interventions

DepodurDRUG

Depodur 10mg given epidurally at end of cesarean section.

DepodurDRUG

Depodur 10mg given epidurally at end of cesarean section after patient received spinal bupivacaine at the beginning of the case.

FentanylDRUG

Epidural fentanyl infusion started after spinal bupivacaine used for the cesarean section.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Degree of analgesia (measured on a 10-point scale)

Time frame: 48 hours post-operatively

Secondary Outcomes

Frequency of minor side effects, such as pruritis or nausea.

Time frame: 48 hours postoperatively

Data from ClinicalTrials.gov

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