Two Dose Epidural Morphine for Post-cesarean Analgesia

Phase 4

Terminated

• Conditions: Pain; Morphine Adverse Reaction
• Interventions: Drug: Epidural Morphine; Drug: Epidural Saline

• Registration Number: NCT01844206
• Lead Sponsor: Columbia University

Brief Summary

The investigators aim to assess the analgesic effect of a two-dose epidural morphine regimen for 2nd day post-cesarean pain, as part of a multimodal analgesia regimen, which includes scheduled Nonsteroidal anti-inflammatory drugs (NSAIDs). The investigators hypothesize that administration of a second dose of epidural morphine 3 mg, 24 hours after an initial intraoperative dose, will provide superior post-cesarean analgesia during the 2nd 24 hours after surgery, compared to a single epidural morphine dose regimen. The primary outcome will be the amount of intravenous morphine patients self-administer during the 2nd 24 hours post-surgery.

Detailed Description

This will be a randomized, double-blinded placebo-controlled study. In this study, women who underwent cesarean section with epidural anesthesia will receive 3 mg of epidural morphine intraoperatively, and have the epidural catheter left in place. Patients will be randomized to receive either epidural saline or epidural morphine 3 mg at 18 - 24 hours after the first dose of epidural morphine, following which the epidural catheter will be removed. It is standard of care at our institution for women undergoing cesarean section with epidural anesthesia to receive epidural morphine 3 mg. What is not typically carried out is to give a second dose of epidural morphine 3mg.

The randomization will be carried out by a computerized block randomization table; the proportion for the 2 groups will be 1:1. The primary outcome will be the amount of intravenous morphine patients self-administer in the second 24 hours after surgery. Secondary outcomes will include pain scores every 6 hours, satisfaction with analgesia, side effects (itching, nausea/vomiting).

Study Timeline

• Study First Submitted: 2013-04-29
• Study First Submitted QC: 2013-04-29
• Study First Posted: 2013-05-01
• Study Start: 2013-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2015-10-16
• Status Verified: 2015-11
• Results First Submitted QC: 2015-11-19
• Last Update Submitted: 2015-11-19
• Results First Posted: 2015-12-23
• Last Update Posted: 2015-12-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

Inclusion Criteria

• Women undergoing cesarean section under epidural anesthesia.

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Exclusion Criteria

• Emergent cesarean section
• Coagulopathy
• Failed epidural anesthesia or patchy block
• General anesthesia
• Use of epidural chloroprocaine
• Allergy or contraindication to Non-steroidal anti-inflammatory drug (NSAIDs)
• Severe opioid side effects
• History of chronic opioid use
• History of chronic pain
• History of obstructive sleep apnea
• Morbid obesity (Body Mass Index (BMI)>45 kg/m2)
• Height under 4' 10" (147 cm)
• Documented dural puncture by the epidural (Tuohy) needle
• Preeclampsia
• Other significant medical disease (American Society of Anesthesiologists (ASA) 3 or more).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural Morphine	Epidural Morphine	Group receiving 3mg epidural morphine, 24 hours after the initial dose
Epidural Saline	Epidural Saline	Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.

Primary Outcome Measures

Name	Time	Method
The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery	Up to 48 hours post-operatively	The primary outcome of this study is the amount (mg) of morphine self-administered by PCA pump during the second 24 hours after surgery. This will be compared by unpaired t-test for two groups.

Trial Locations

Locations (1)

New York Presbyterian Hospital; 🇺🇸 New York, New York, United States