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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03267628
Enrollment
0
Registered
2017-08-30
Start date
2019-01-01
Completion date
2019-12-31
Last updated
2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section, Pain, Acute

Keywords

intrathecal morphine, quadratus lumborum type 2 block, cesarean section, pain

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.

Interventions

PROCEDUREIntrathecal 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.

PROCEDUREIntrathecal 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.

PROCEDURESaline 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.

PROCEDURESaline 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.

Sponsors

Sunshine Coast Hospital and Health Service
CollaboratorOTHER
Dr Willem Basson
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double blinded

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
24 hours total intravenous morphine usage via a PCA pump24 hoursPost operative intravenous morphine use will be noted at 24 hours post cesarean section

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026