Quadratus Lumborum Block (QLB) for Pain Relief After Caesarean Section
1 other identifier
interventional
90
1 country
1
Brief Summary
There is currently a gap in the literature with regards to the utility of the QLB performed in conjunction with intrathecal morphine (ITM) for Caesarean section. The aim of the study is to assess the efficacy of the QLB as part of a multi-modal analgesic approach in patients after caesarean section.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2018
CompletedFirst Posted
Study publicly available on registry
October 4, 2018
CompletedStudy Start
First participant enrolled
October 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 24, 2019
CompletedJuly 23, 2019
July 1, 2019
6 months
October 1, 2018
July 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IV PCA Morphine consumption up to 24 hours.
Intravenous PCA (patient controlled analgesia) morphine consumption up to 24 hours.
24 hours
Secondary Outcomes (7)
Pain scores at rest.
6, 12, 24, 48 hours
Pain scores on movement.
6, 12, 24, 48 hours
Nausea and vomiting.
24, 48 hours
IV PCA morphine bolus demands.
24 hours
Total opioid consumption at 48 hours.
48 hours
- +2 more secondary outcomes
Study Arms (2)
Quadratus lumborum block
ACTIVE COMPARATORBilateral posterior QLB with 20ml 0.25% L-Bupivacaine.
Sham QLB
SHAM COMPARATORSham QLB - Ultrasound identification of QLB followed by skin pressure with blunt needle. Patient blinded due to residual spinal anaesthetic block.
Interventions
Ultrasound guided Quadratus Lumborum block using a posterior approach. (QLB 2)
Sham QLB - Ultrasound identification of QLB followed by skin pressure with blunt needle.
Eligibility Criteria
You may qualify if:
- Elective Caesarean section under spinal anaesthesia.
- Age \> 18 years old.
- Singleton pregnancy.
You may not qualify if:
- Contraindication to spinal or regional anaesthesia.
- Allergy/sensitivity/contraindication to study medications.
- Unable to comprehend visual analogue scale.
- BMI \> 40.
- Booking weight \<40kg.
- History of chronic pain or regular opioid use.
- Pre-eclampsia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Coombe Women and Infants University Hospital
Dublin, 00000, Ireland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Terry Tan
Head of Department of Anaesthesia CWIUH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 1, 2018
First Posted
October 4, 2018
Study Start
October 30, 2018
Primary Completion
April 24, 2019
Study Completion
April 24, 2019
Last Updated
July 23, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share