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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Pain, Acute; Cesarean Section
• Intervention / Treatment: Procedure: Saline intrathecal as well as saline in Blocks; Procedure: Saline intrathecal as well as local anaesthetic in Blocks; Procedure: Intrathecal morphine as well as local anaesthetic in Blocks; Procedure: Intrathecal morphine as well as saline in Block

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Saline intrathecal as well as saline in Blocks; 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; 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.; Procedure: Saline intrathecal as well as local anaesthetic in Blocks; 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.
Active Comparator: Saline intrathecal as well as local anaesthetic in Blocks; These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.	Procedure: Saline intrathecal as well as saline in Blocks; 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.; Procedure: Intrathecal morphine as well as local anaesthetic in Blocks; 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.
Active Comparator: Intrathecal morphine as well as local anaesthetic in Blocks; 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; 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.; Procedure: Intrathecal morphine as well as saline in Block; 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.
Active Comparator: Intrathecal morphine as well as saline in Block; These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.	Procedure: Saline intrathecal as well as local anaesthetic in Blocks; 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.; Procedure: Intrathecal morphine as well as saline in Block; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr Willem Basson
• Collaborators: Sunshine Coast Hospital and Health Service
• Investigators: Principal Investigator: Willem Basson, FANZCA, Sunshine Coast University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 30, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: pain; cesarean section; intrathecal morphine; quadratus lumborum type 2 block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Anesthetics; Anesthetics, Local; Morphine
• Other Study ID Numbers: HREC/17/QPCH/121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No