Decreased Neuraxial Morphine After Cesarean Delivery

Study Overview
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Brief Summary
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The purpose of this study is to compare 50mcg to 150mcg morphine in epidural for the goal of decreasing side effects of medication with lower dose in patients who receive a QL block

Detailed Description
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Regional anesthesia has been associated with reduced opioid consumption after surgery. Cesarean delivery is one of the most commonly performed surgeries worldwide and women undergoing cesarean delivery are often young, opioid-naïve, and motivated to recover quickly in an effort to better care for their newborn. However, approximately 1 in 300 opioid naïve women become persistent prescription opioid users following cesarean delivery . Hence, it is important to optimize post-cesarean pain control while limiting exposure to opioids. Currently, standard therapy includes the use of neuraxial morphine (NM) in combination with a multi-modal regime in an effort to limit excessive opioid use after cesarean delivery. The current typical dose of NM that is given prior to cesarean delivery at the investigator's center is 150 mcg. Importantly, NM doses as low as 100 mcg have been shown to provide comparable analgesia while reducing side effects such as itching. The side-effect profile associated with NM includes up to 87% of patients experiencing pruritus and up to 70% experiencing urinary retention. Nausea and vomiting also lead to significant discomfort for a new mother trying to provide acute infant care. Adjunctive Peripheral Nerve Blockade has recently been introduced to reduce postoperative pain and opioid use. Studies have assessed the usefulness of the transversus abdmoninis plane (TAP) block after cesarean delivery. Another ultrasound-guided injection of local anesthetic in the fascial plane (truncal block) that is available at UAB and within the standard of care for patients undergoing abdominal surgery is the quadratus lumborum (QL) block. Because of its more posterior and caudal location, it is more likely to anesthetize the nerve fibers associated with pain from cesarean delivery. This study will compare the use of 50mcg to 150mcg morphine for the goal of decreasing side effects of medication with lower dose in all patients who receive a QL block

Official Title
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Decreased Neuraxial Morphine and Adjunctive Peripheral Nerve Blockade to Reduce Severity of Side Effects and Opioid Use After Cesarean Delivery

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Morphine Sulfate 150 mcg
* Drug: Morphine Sulfate 50mcg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All women presenting for scheduled cesarean delivery who desire a QL block Exclusion Criteria: Women with pregnancies complicated by preeclampsia Women with pregnancies complicated by insulin-treated diabetes Women with pregnancies complicated by placental abnormalities Women with pregnancies complicated by a history of opioid use disorder
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: Group A: 150 mcg morphine<br>Patients in this group will receive 150mcg of morphine in their neuraxial block | Drug: Morphine Sulfate 150 mcg<br>* Use of 150mcg of morphine sulfate for neuraxial block (dosing difference)<br>|
| Experimental: Group B: 50 mcg morphine<br>Patients in this group will receive 50mcg of morphine in their neuraxial block | Drug: Morphine Sulfate 50mcg<br>* Use of 50mcg of morphine sulfate for neuraxial block (dosing difference)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome of side effects of intervention: pruritus | Incidence of primary outcome surrogate marker by need for medication for pruritus based on verbal complaints from patient (Medication given: Yes or No) | One assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery) | 
| Outcome of side effects of intervention: nausea | Incidence of primary outcome surrogate marker by need for medication for nausea based on verbal complaints from patient (Medication given: Yes or No) | One assessment during hospital stay - up to postoperative day 2 | 
| Outcome of side effects of intervention: urinary retention | Incidence of primary outcome surrogate marker by need for removal of foley catheter as measure for urinary retention | One assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal secondary outcomes from intervention | Total amount of morphine use during hospital stay (cumulative morphine administered to control pain during hospital stay) | One assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery) | 
| Maternal secondary outcomes from intervention | Incidence of daily pain scores (measured by pain score ratings: 1-10); 1: lowest pain score 10: maximum pain score | One measurement during entire hospital stay | 
| Neonatal secondary outcomes from intervention | Apgar scores | Within first hour of birth | 
| Neonatal secondary outcomes from intervention | Incidence of babies with signs of respiratory depression | Within first hour of birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean delivery, epidural, Neuraxial block, anesthesia side effects