- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03526731
Analgesic Efficacy of Trans-muscular Quadratus Lumborum Block After Unilateral Inguinal Hernia Repair
Quadratus Lumborum Block for Postoperative Pain Control in Patients Undergoing Unilateral Inguinal Hernia Repair, a Comparative Study Between Two Approaches
A significant component of pain experienced after abdominal surgery is related to incision of the abdominal wall and adequate analgesia can be a challenge.
The ultrasound-guided (USG) quadratus lumborum block QLB was first described by Rafael Blanco in a presentation at ESRA 2007 at the XXVI Annual ESRA Congress in Valencia, Spain. Blanco described a potential space posterior to the abdominal wall muscles and lateral to the quadratus lumborum muscle where Local anesthetics can be injected. This technique provide analgesia after abdominal surgery due to spread of LA from its lumbar deposition cranially into the thoracic paravertebral space where lateral and anterior cutaneous branches from Th7 to L1 can be blocked . This was proved by Carney et al. who found traces of contrast agent in the TPVS following application of this block A novel USG QL block is the transmuscular approach which relies on clearly identifiable sonographic bony landmarks, Where the needle is advanced through the QL muscle, penetrating the ventral proper fascia of the QL muscle and LA is finally injected between the QL and Psoas major (PM) muscle. The transmuscular QL block does not result in redundant antero-lateral spread of the injectate. This may indicate that lower volumes of LA potentially can be used and yet provide extensive thoracolumbar anesthesia.
This study was designed to compare the duration of analgesia provided by the original QLB and transmuscular QLB in patients undergoing surgical repair of unilateral inguinal hernia.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Cairo, Egypt, 002211
- Abeer Ahmed
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ASA physical status I or II, scheduled for unilateral inguinal hernia repair
Exclusion Criteria:
- Patients with systemic hypertension, cardiovascular disease, cerebrovascular insufficiency, coagulation abnormities, renal or hepatic insufficiency, infection at the injection site, strangulated hernia and hypersensitivity to the local anesthetics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group A (original QLB-2):
Local anesthetic will be injected between the quadratus lumborum muscle and the latissimus dorsi muscle guided by ultrasound.
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ultrasound guided quadratus lumborum block for post operative pain control after unilateral inguinal hernia repair.
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EXPERIMENTAL: Group B (trans-muscular OLB-3)
Local anesthetic will be injected between quadratus lumborum and psoas major after passing through the quadratus lumborum muscle guided by ultrasound.
|
ultrasound guided quadratus lumborum block for post operative pain control after unilateral inguinal hernia repair.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
duration of block
Time Frame: immediately after the end of LA injection till patients pain complaint (VAS > 3) over a period of 24 hours postoperative.
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immediately after the end of LA injection till patients pain complaint (VAS > 3) over a period of 24 hours postoperative.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Abeer Ahmed, MD, Faculty of Medicine - Cairo University _ Egypt
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N-13-2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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