Depodur vs Fentanyl Infusion for Post-C/S Analgesia

Goodman, Evan, M.D.

Status: Withdrawn

Conditions: Analgesia

Treatments: Drug: Depodur; Drug: Fentanyl

Study type: Interventional

Identifiers

NCT00762554

goodman-1

Details and patient eligibility

About

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

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

1

Active Comparator group

Description:

Epidural Depodur after spinal bupivacaine

Treatment:

Drug: Depodur

Drug: Depodur

2

Active Comparator group

Description:

Epidural fentanyl infusion after epidural lidocaine or spinal bupivacaine

Treatment:

Drug: Fentanyl