Comparison of the Erector Spinae Plane Block Versus Intrathecal Morphine on Post-Cesarean Delivery Analgesia

Study Overview
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Brief Summary
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This study is a Randomized Control Trial comparing the Erector Spinae Plane Block with intrathecal morphine for post cesarean delivery analgesia.

Official Title
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Comparison of the Erector Spinae Plane Block Versus Intrathecal Morphine on Post-Cesarean Delivery Analgesia

Conditions
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Cesarean Section Complications

Intervention / Treatment
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* Procedure: Erector Spinae Plane Block
* Drug: Intrathecal morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing scheduled Cesarean delivery Exclusion Criteria: Patients with an ASA score greater than 3 Allergies to study medications Contraindications to neuraxial analgesia Patients with chronic pain Patients unable to communicate in the study language

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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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intrathecal morphine<br> | Drug: Intrathecal morphine<br>* Intrathecal morphine at the time of spinal anesthesia<br>|
| Experimental: Erector Spinae Plane Block<br> | Procedure: Erector Spinae Plane Block<br>* A nerve block that injects local anesthetic in the Erector Spinae Plane<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour area under the curve pain scores | It will be measured at 3 6 12 18 and 24 hours after the end of the cesarean delivery. This pain will be assessed by asking the patient to go from lying to sitting (or use incentive spirometry) and rated using a linear 10 cm visual analogue scale (VAS). The 24 hour pain VAS area under the curve (AUC) will be calculated using the trapezoid rule. | First 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of quality of recovery after cesarean delivery | At 24 hours the ObsQoR11, a validated instrument to measure the quality of recovery after cesarean delivery, will be administered to the patient | First 24 hours | 
| Nausea and vomiting | The incidence of nausea and vomiting will be rated on a 10 cm VAS | First 24 hours | 
| Analgesic usage | The cumulative use of opioids, expressed as morphine equivalents will be recorded at 24 hours. | First 24 hours | 
| Pruritus | The incidence of pruritus will be rated on a 10 cm VAS | First 24 hours | 
| Incidente of persistent surgical pain | Patients will be contacted by telephone 3 months after the cesarean to assess the presence of chronic pain. This will be done using a modification of the brief pain inventory | Three months |