Comparison of Intrathecal Morphine With the Quadratus Lumborum Type 2 Block for Post-operative Analgesia Following Elective Caesarean Section (QLBvITM Study)

Study Overview
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Brief Summary
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The investigators are comparing post operative analgesia provided for caesarean section patients, with the quadratus lumborum type 2 block and intrathecal morphine.

Detailed Description
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In Australia the rate of birth via caesarean section (CS) has significantly increased over the last twenty years. Improvements in the care of women undergoing CS are important locally, nationally and internationally. Compared to women birthing vaginally, women undergoing CS experience more adverse events and more pain. Effective pain relief following CS is important as it enables early ambulation, encourages maternal bonding, and promotes breastfeeding initiation and establishment. Traditional analgesic techniques following CS include opioid medications. Whist effective, the use of opioids are associated with frequent and significant side effects. Alternative analgesic agents are being explored in an attempt to improve the effectiveness of pain relief available to women and clinicians. The quadratus lumborum block (QLB) block is an innovative regional analgesic technique. Its role as an effective analgesic agent in abdominal surgery is increasing. However, it has not been studied for pain relief in Australia after cesarean section. In this study, the investigator aims to compare post-operative analgesia and side effects between the QLB blocks versus adding morphine the participant's spinal anaesthetic (ITM) during the elective C/S. Results from this study will provide information on the analgesic impact of this new and emerging therapy and assist in the development of a larger clinical trial.

Official Title
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Quadratus Lumborum Type 2 Block Versus Intrathecal Morphine for Analgesia Following Elective Caesarean Sections

Conditions
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Cesarean Section, Pain, Acute

Intervention / Treatment
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* Procedure: Intrathecal morphine as well as local anaesthetic in Blocks
* Procedure: Intrathecal morphine as well as saline in Block
* Procedure: Saline intrathecal as well as saline in Blocks
* Procedure: Saline intrathecal as well as local anaesthetic in Blocks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anaesthetist trained in QLB and ITM techniques available American Society of Anaesthesiologists PS category client I or II 18 years of age or older Ability to read and understand English Uncomplicated pregnancy at term (>37 weeks completed gestation) Booked elective CS Exclusion Criteria: Contraindications to spinal anaesthesia History of chronic opioid consumption / chronic pain conditions Known allergy to study drugs Weight more than 95kg or body mass index (BMI) more than 35 pre operative Placenta Previa / accreta Obstructive Sleep apnoea Severe asthma unable to tolerate Non steroidal anti inflammatory agents

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 4 groups of 25 patients each. All patients will receive a spinal and a quadratus lumborum type 2 block. The groups will have a combination of ITM / QLB or both or neither.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Saline intrathecal as well as saline in Blocks<br>These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml saline both sides as a QLB2. | Procedure: Saline intrathecal as well as saline in Blocks<br>* 0.3 ml saline will be added to the spinal anaesthetic. 25 ml saline will be used on each side during a quadratus lumborum type 2 block.<br>Procedure: Saline intrathecal as well as local anaesthetic in Blocks<br>* 0.3 ml saline will be added to the spinal anaesthetic. A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle.<br>|
| Active Comparator: Saline intrathecal as well as local anaesthetic in Blocks<br>These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2. | Procedure: Intrathecal morphine as well as local anaesthetic in Blocks<br>* A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle. 150mcg morphine will be added to the spinal anaesthetic.<br>Procedure: Saline intrathecal as well as saline in Blocks<br>* 0.3 ml saline will be added to the spinal anaesthetic. 25 ml saline will be used on each side during a quadratus lumborum type 2 block.<br>|
| Active Comparator: Intrathecal morphine as well as local anaesthetic in Blocks<br>These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2. | Procedure: Intrathecal morphine as well as local anaesthetic in Blocks<br>* A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle. 150mcg morphine will be added to the spinal anaesthetic.<br>Procedure: Intrathecal morphine as well as saline in Block<br>* 150mcg morphine will be added to the spinal anaesthetic. 25 ml saline will be used on each side during a quadratus lumborum type 2 block.<br>|
| Active Comparator: Intrathecal morphine as well as saline in Block<br>These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml saline both sides as a QLB2. | Procedure: Intrathecal morphine as well as saline in Block<br>* 150mcg morphine will be added to the spinal anaesthetic. 25 ml saline will be used on each side during a quadratus lumborum type 2 block.<br>Procedure: Saline intrathecal as well as local anaesthetic in Blocks<br>* 0.3 ml saline will be added to the spinal anaesthetic. A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hours total intravenous morphine usage via a PCA pump | Post operative intravenous morphine use will be noted at 24 hours post cesarean section | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's side effects within the 24 hours post operative period. | Nausea, vomiting, itching, herpes reactivation, urinary retention and sedation will be noted. | 24 hours | 
| Pain Scores within 24 hours post operative period. | Using a VAS we will note both dynamic and static pain scores at 24 hours post operative | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intrathecal morphine, quadratus lumborum type 2 block, cesarean section, pain