Postoperative Pain Relief After Cesarean Section: Is There a Role for the Quadratus Lumborum Block?
1 other identifier
interventional
50
1 country
1
Brief Summary
The Quadratus Lumborum block (QLB) was first described by Blanco in 2007. The main advantage of QLB compared to the Transversus Abdominis Plane block (TAP) is the extension of local anesthetic agent beyond the TAP plane to the thoracic paravertebral space. The wider spread of the local anesthetic agents produces extensive analgesia and prolonged action of the injected local anesthetic solution. Previous studies showed that TAP block may not be effective in improving postoperative analgesia in patients who had cesarean section under spinal anaesthesia. The aim of this randomised controlled, double blinded study is to examine the effect of QLB on the postoperative pain management in patients who had cesarean section under spinal anesthesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable postoperative-pain
Started Sep 2014
Shorter than P25 for not_applicable postoperative-pain
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
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 25, 2014
CompletedFirst Posted
Study publicly available on registry
December 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedMay 24, 2016
May 1, 2016
6 months
December 25, 2014
May 22, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Total morphine used in the first 48 hours after surgery
Total cumulative morphine dose in mg used in the first 48 hours after surgery
48 hours
Secondary Outcomes (3)
Nausea or vomiting
48 hours
Sedation score in the first 48 hours
48 hours
Severity of postoperative pain via visual analogue pain scale
48 hours
Study Arms (2)
Quadratus Lumborum block group (QL)
ACTIVE COMPARATORpatients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.125%
Control Group
PLACEBO COMPARATORpatients will receive a bilateral placebo block
Interventions
Patients will receive a bilateral Quadratus Lumborum block using 0.125% Bupivacaine in a dose of 0.2ml/kg body weight, after the end of surgery.
Eligibility Criteria
You may qualify if:
- Elective caesarean sections
- ASA 1 to 3
- Written informed consent.
You may not qualify if:
- Patient refusal
- Local infection at the site of injection
- Allergy to study medications
- Sepsis
- Anatomic abnormalities
- Systemic anticoagulation or coagulopathy
- Inability to comprehend or participate in pain scoring system
- Inability to use intravenous patient controlled analgesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dr. Tarek Ansarilead
Study Sites (1)
Corniche Hospital
Abu Dhabi, 3788, United Arab Emirates
Related Publications (1)
Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
PMID: 26225500DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rafa Blanco, FRCA
Corniche Hospital
- PRINCIPAL INVESTIGATOR
Tarek Ansari, FFARCSI
Corniche Hospital
- PRINCIPAL INVESTIGATOR
Emad Girgis, MD
Corniche Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Consultant Anesthetist
Study Record Dates
First Submitted
December 25, 2014
First Posted
December 31, 2014
Study Start
September 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
May 24, 2016
Record last verified: 2016-05