Depodur vs Fentanyl Infusion for Post-C/S Analgesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Epidural Depodur after spinal bupivacaine

Group Type ACTIVE_COMPARATOR

Depodur

Intervention Type DRUG

Depodur 10mg given epidurally at end of cesarean section.

Depodur

Intervention Type DRUG

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

2

Epidural fentanyl infusion after epidural lidocaine or spinal bupivacaine

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

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

Interventions

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Depodur

Depodur 10mg given epidurally at end of cesarean section.

Intervention Type DRUG

Depodur

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

Intervention Type DRUG

Fentanyl

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes