Two Dose Epidural Morphine for Post-cesarean Analgesia

Study Overview
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Brief Summary
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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
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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).

Official Title
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Two Dose Epidural Morphine for Post-cesarean Analgesia

Conditions
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Pain, Morphine Adverse Reaction

Intervention / Treatment
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* Drug: Epidural Morphine
* Drug: Epidural Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women undergoing cesarean section under epidural anesthesia. 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural Morphine<br>Group receiving 3mg epidural morphine, 24 hours after the initial dose | Drug: Epidural Morphine<br>* Patients will be given 3mg epidural morphine, 24 hours after the initial dose.<br>* Other names: DepoDur;|
| Placebo Comparator: Epidural Saline<br>Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg. | Drug: Epidural Saline<br>* Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.<br>* Other names: Sodium Chloride Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery | 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. | Up to 48 hours post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-cesarean analgesia, Second dose of epidural morphine after surgery, Post-operative analgesia, Self-administered epidural morphine, Pain management after cesarean