Epidural Morphine for Analgesia After Traumatic Vaginal Delivery

Study Overview
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Brief Summary
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This pilot study intends to establish the efficacy of 2 different doses of epidural morphine for pain management after perineal trauma when using multimodal analgesia as well as the feasibility of conducting a larger randomized clinical trial. Women with traumatic vaginal delivery will be randomized into 3 groups with 10 patients each and receive 2.5 mg epidural morphine, 1.25 mg epidural morphine, or epidural saline. The primary outcome is total opioid consumption for breakthrough pain in the first 24 hours.

Official Title
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Efficacy of Two Doses of Epidural Morphine for Analgesia After Traumatic Vaginal Delivery: a Randomized, Double Blinded, Placebo-controlled Pilot Study

Conditions
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Traumatic Vaginal Delivery

Intervention / Treatment
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* Drug: Morphine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is 18 years or older The patient is ASA 1-3 Gestation 37-42 weeks The patient had a vaginal delivery The patient received epidural analgesia for labor and delivery Exclusion Criteria: The patient has refused to participate The patient cannot give informed consent The investigator has significant concerns for maternal or neonatal welfare The patient has a history of allergy to opioids The patient has a history of chronic opioid consumption The patient has a history of narcotic abuse The patient has an allergy to local anesthetics The patient has a contraindication to taking NSAIDs or acetaminophen The patient received combined spinal-epidural analgesia The patient has a history of chronic pain

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Low dose epidural morphine<br>One dose of 1.25 mg epidural morphine | Drug: Morphine<br>* Comparison of different dosages of drug<br>|
| Active Comparator: High dose epidural morphine<br>One dose of 2.5 mg epidural morphine | Drug: Morphine<br>* Comparison of different dosages of drug<br>|
| Placebo Comparator: Saline<br>One dose of 10 ml saline administered through an epidural catheter | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total breakthrough opioid consumption |  | First 24 hours after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores at rest |  | At 6, 12, 24, and 36 h after delivery | 
| Pain scores with movement |  | At 6, 12, 24, and 36 h after delivery | 
| Severity of nausea/vomiting |  | At 6, 12, 24, and 36 h after delivery | 
| Severity of pruritis |  | At 6, 12, 24, and 36 h after delivery | 
| Severity of sedation |  | At 6, 12, 24, and 36 h after delivery | 
| Time to first request for additional analgesia |  | First 36 h after delivery | 
| Patient satisfaction with pain control |  | At 24 and 36 h after delivery | 
| Quality of Recovery |  | At 24 and 36 h after delivery | 
| Antiemetic consumption |  | First 36 h after delivery | 
| Antipruritic medication consumption |  | First 36 h after delivery | 
| Total opioid consumption |  | First 36 h after delivery |