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

Not Applicable

Withdrawn

• Conditions: Pain, Acute; Cesarean Section
• Interventions: Procedure: Saline intrathecal as well as saline in Blocks; Procedure: Intrathecal morphine as well as local anaesthetic in Blocks; Procedure: Saline intrathecal as well as local anaesthetic in Blocks; Procedure: Intrathecal morphine as well as saline in Block

• Registration Number: NCT03267628
• Lead Sponsor: Dr Willem Basson

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-30
• Study Start: 2019-01-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-17
• Primary Completion: 2019-11-01
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline intrathecal as well as saline in Blocks	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.
Saline intrathecal as well as local anaesthetic in Blocks	Intrathecal morphine 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.
Saline intrathecal as well as local anaesthetic in Blocks	Saline intrathecal as well as saline 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.
Intrathecal morphine as well as saline in Block	Saline intrathecal as well as local anaesthetic in Blocks	These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.
Intrathecal morphine as well as local anaesthetic in Blocks	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 local anaesthetic both sides as a QLB2.
Saline intrathecal as well as saline in Blocks	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 saline both sides as a QLB2.
Intrathecal morphine as well as local anaesthetic in Blocks	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.
Intrathecal morphine as well as saline in Block	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.

Primary Outcome Measures

Name	Time	Method
24 hours total intravenous morphine usage via a PCA pump	24 hours	Post operative intravenous morphine use will be noted at 24 hours post cesarean section

Secondary Outcome Measures

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