Intrathecal Morphine vs. Intrathecal Morphine and Regional Anesthesia After Cesarean Section.

Study Overview
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Brief Summary
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The objective of the study is to optimize post-operative analgesia and improve patient satisfaction while reducing total opioid consumption after cesarean section

Official Title
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Comparing Intrathecal Morphine and Erector Spinae Plane Regional Anesthesia Against Intrathecal Morphine Alone for Post-Cesarean Section Pain

Conditions
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Post-operative Pain

Intervention / Treatment
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* Procedure: erector spinae plane block (ESP)
* Drug: Duramorph
* Drug: Ropivacaine
* Drug: Bupivacaine Injection


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Able to consent BMI<35 Exclusion Criteria: Adults unable to consent BMI>35 Individuals <18 years of age at time of admission Individuals taking anticoagulant medications Significant co-morbid disease of pregnancy (including: gestational diabetes and significant abnormal placentation) Pre-existing chronic pain or pain disorder diagnosis Conversion from neuraxial to general anesthesia Prisoners

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: erector spinae plane block<br>participants will be in this group for up to 9 months and receive erector spinae plane (ESP) block | Procedure: erector spinae plane block (ESP)<br>* nerve block for abdominal pain. administered once immediately prior to spinal anesthetic standard of care.<br>Drug: Duramorph<br>* 100 micrograms (mcg) of morphine administered in the spinal medications one time.<br>Drug: Ropivacaine<br>* Ropivacaine 0.5% between 20-40 milliliters will be administered once in the ESP block (in the spine) depending on patient weight to keep under the maximum dose.<br>Drug: Bupivacaine Injection<br>* Bupivacaine 0.75% 1.4-1.7 milliliters (10-12 milligrams) spinal medication. administered one time.<br>|
| Experimental: standard of care<br>participants in this group will receive the standard of care treatment and will be in this group for up to 9 months. | Drug: Duramorph<br>* 100 micrograms (mcg) of morphine administered in the spinal medications one time.<br>Drug: Ropivacaine<br>* Ropivacaine 0.5% between 20-40 milliliters will be administered once in the ESP block (in the spine) depending on patient weight to keep under the maximum dose.<br>Drug: Bupivacaine Injection<br>* Bupivacaine 0.75% 1.4-1.7 milliliters (10-12 milligrams) spinal medication. administered one time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative opioid analgesic medication | measurement (milligrams) | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in post-operative pain medication by visual analog scale | Patient administered instrument to indicate pain on a level from 0 to10. (0: no pain. 10: worst imaginable pain) | baseline, up to 24 hours | 
| number of minutes to first use of rescue medication | the number of minutes calculated using the kaplan-meier. Calculated using the number of patients that did not need the rescue analgesic at the start of each day post-surgery, and the number of patients who needed the rescue analgesic. | up to 24 hours | 
| obstetric quality of recovery scale | responses range from 0-10. zero is strongly agree, strongly disagree. | up to 24 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erector spinae plane block