- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03733769
A Novel Approach for Transmuscular Quadratus Lumborum Block
January 16, 2019 updated by: Ahmad Samir Alabd, Alexandria University
A Novel Approach for Transmuscular Quadratus Lumborum Block for Peri-operative Analgesia in Hip Surgery
a novel approach for TQL (anterior Q.L) block aiming mainly for terminal branches of lumbar plexus.
The technique is described as Para-Spinous Saggital Shift Q.L block, done at L4 transverse process level in saggital orientation.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
With this approach, we think it has advantages of easy identification, better caudal LA spread till under fascia iliaca, with the psoas major muscle provides a better protective barrier against accidental needle entry into the peritoneal cavity, the endpoint is injection within a fascial plane, rather than a specific motor response contact where the lumbar plexus stimulation is not sought, so there is minimal risk of nerve injury, inadvertent dural cuff puncture and intrathecal spread of local anesthetic.
And finally optimal insertion of catheter in long axis of Q.L and psoas major if continuous analgesia is planned.
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Alexandria, Egypt, 21131
- Alexandria Faculty of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Orthopaedic patients, American Society of Anesthesiologists (ASA) physical status I-III, scheduled to undergo unilateral hip surgery.
Exclusion Criteria:
- History of neurological/neuromuscular, psychiatric disease, dementia preventing proper comprehension.
- Patients with Body Mass Index (BMI) <18.5 or >30 kg/m2.
- Coagulation disturbances (INR>1.4, platelet count<100 000).
- History of opioid dependence (opioid use within the last 4 weeks).
- History of allergies to study medications.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TQL group
transmuscular quadratus lumborum block as an alternative to lumbar plexus block for peri-operative analgesia in hip Surgery
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transmuscular quadratus lumborum block as an alternative to lumbar plexus block for peri-operative analgesia in hip Surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
peri-operative analgesia in hip Surgery
Time Frame: one month
|
post-operative VAS score
|
one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Emad A Abdelmonem, Alexandria Faculty of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Carline L, McLeod GA, Lamb C. A cadaver study comparing spread of dye and nerve involvement after three different quadratus lumborum blocks. Br J Anaesth. 2016 Sep;117(3):387-94. doi: 10.1093/bja/aew224.
- Adhikary SD, Short AJ, El-Boghdadly K, Abdelmalak MJ, Chin KJ. Transmuscular quadratus lumborum versus lumbar plexus block for total hip arthroplasty: A retrospective propensity score matched cohort study. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):372-378. doi: 10.4103/joacp.JOACP_335_17.
- Adhikary SD, El-Boghdadly K, Nasralah Z, Sarwani N, Nixon AM, Chin KJ. A radiologic and anatomic assessment of injectate spread following transmuscular quadratus lumborum block in cadavers. Anaesthesia. 2017 Jan;72(1):73-79. doi: 10.1111/anae.13647. Epub 2016 Oct 12.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 6, 2018
Primary Completion (Actual)
January 15, 2019
Study Completion (Actual)
January 15, 2019
Study Registration Dates
First Submitted
November 6, 2018
First Submitted That Met QC Criteria
November 6, 2018
First Posted (Actual)
November 7, 2018
Study Record Updates
Last Update Posted (Actual)
January 17, 2019
Last Update Submitted That Met QC Criteria
January 16, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- TQL block in hip surgery
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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