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

Dr Willem Basson

Status: Withdrawn

Conditions: Cesarean Section; Pain, Acute

Treatments: Procedure: Intrathecal morphine as well as local anaesthetic in Blocks; 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 saline in Block

Study type: Interventional

Funder types: Other

Identifiers

NCT03267628

HREC/17/QPCH/121

Details and patient eligibility

About

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

Full 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.

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 4 patient groups

Saline intrathecal as well as saline in Blocks

Sham Comparator group

Description:

These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.

Treatment:

Procedure: Saline intrathecal as well as local anaesthetic in Blocks

Procedure: Saline intrathecal as well as saline in Blocks

Saline intrathecal as well as local anaesthetic in Blocks

Active Comparator group

Description:

These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.

Treatment:

Procedure: Intrathecal morphine as well as local anaesthetic in Blocks

Procedure: Saline intrathecal as well as saline in Blocks

Intrathecal morphine as well as local anaesthetic in Blocks

Active Comparator group

Description:

These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.

Treatment:

Procedure: Intrathecal morphine as well as local anaesthetic in Blocks

Procedure: Intrathecal morphine as well as saline in Block

Intrathecal morphine as well as saline in Block

Active Comparator group

Description:

These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.

Treatment:

Procedure: Intrathecal morphine as well as saline in Block

Procedure: Saline intrathecal as well as local anaesthetic in Blocks