A Randomized Controlled Trial Comparing Intrathecal Morphine With Quadratus Lumborum Block for Post-cesarean Delivery Analgesia

Study Overview
=================
Brief Summary
-----------------
Pain after caesarean delivery (CD) can interfere with the moms' ability to look after her baby and may contribute to developing long term pain and disability. Women having a CD receive pain medication (morphine) as part of their spinal anesthetic to help with pain relief after surgery. Morphine works well however has several side effects such as nausea, vomiting and itching which may be severe enough to make it difficult to care for herself and her new baby. In some cases, morphine causes difficulty in passing urine within first 24-hours of the CD requiring catheterization and thus restricting mobilization. The quadratus lumborum block (QLB) is a newer nerve block that uses local anaesthetic solution to numb the nerves carrying pain sensation from surgical incision site. QLB may be able to provide effective pain control without the side-effects associated with the spinal morphine. This study is to determine if women receiving QLB have as good pain control with fewer side effects than those who do receive the spinal morphine. Adequate pain control will be assessed by their pain scores and recovery in the 24 to 48 hours after CD. The side effect profile of the two techniques, quality of recovery and long term impact will also be compared during this study. In addition, we would like to compare the patients who received both analgesic regimens (ITM and QLB) with patients who received only one analgesic intervention (i.e. either ITM or QLB). Further, the study will help us answer if combining the two analgesic interventions if beneficial or not.

Official Title
-----------------
A Randomized Controlled Trial Comparing Intrathecal Morphine With Quadratus Lumborum Block as Part of a Multimodal Analgesia Strategy for Post-cesarean Delivery Analgesia

Conditions
-----------------
Cesarean Section

Intervention / Treatment
-----------------
* Other: Bilateral Quadratus lumborum block with 0.5% ropivacaine
* Other: Intrathecal Morphine with 100 mcg morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-emergent CD with planned spinal anesthesia American Society of Anesthesia physical status class I & II; Age ≥18 years; Term gestational age (≥37 weeks); Singleton pregnancy; English-speaking. Exclusion Criteria: Morbid Obesity (BMI ≥35 kg/m2); Subjects with significant obstetric or neonatal co-morbidities; Patient enrollment in another study involving medication within 30 days of CD; Any other condition, which may impair patients ability to co-operate with data collection; Patient height less than 152 cm (5'0); History of opioid tolerance or sensitivity; Intolerance to non-steroidal anti-inflammatory drugs (NSAIDs); Women with a history of illicit drug use or prescribed opioids or benzodiazepines.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intrathecal morphine<br>Intrathecal morphine 100 mcg | Other: Intrathecal Morphine with 100 mcg morphine<br>* Intrathecal Morphine with 100 mcg morphine<br>|
| Experimental: Quadratus lumborum block<br>Bilateral QLB with 20 ml of 0.5% ropivacaine per side (maximum total dose 3 mg/kg) | Other: Bilateral Quadratus lumborum block with 0.5% ropivacaine<br>* Bilateral Quadratus lumborum block with 0.5% ropivacaine<br>|
| Experimental: Intrathecal morphine + Quadratus lumborum block<br>Bilateral QLB with 20 ml of 0.5% ropivacaine per side (maximum total dose 3 mg/kg) + Intrathecal morphine 100 mcg | Other: Bilateral Quadratus lumborum block with 0.5% ropivacaine<br>* Bilateral Quadratus lumborum block with 0.5% ropivacaine<br>Other: Intrathecal Morphine with 100 mcg morphine<br>* Intrathecal Morphine with 100 mcg morphine<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of recovery (QoR) score |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine equivalent consumption | morphine equivalent consumption in the 24-h and 48-h period after spinal insertion | 24 hours and 48 hours | 
| Quality of recovery (QoR) score |  | 48 hours | 
| Incidence of nausea/vomiting needing treatment |  | 24 hours | 
| Incidence of itching needing treatment. |  | 24 hours | 
| Incidence of respiratory depression needing treatment. |  | 24 hours | 
| Worst pain scores | The primary outcome will be highest pain intensity during first 24-h as measured | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
quadratus lumborum block