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

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03267628
• Other study ID #: HREC/17/QPCH/121
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2019
• Source: Sunshine Coast Hospital and Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Cesarean Section
• Pain, Acute

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Dr Willem Basson	Sunshine Coast Hospital and Health Service

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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