- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04292782
Quadratus Lumborum Block for Pediatric Hip Surgery
Caudal Epidural Block Compared to Anterior Quadratus Lumborum Block for Pediatric Hip Surgery
Caudal blockade (CB) is one of the most frequently performed regional anaesthetic techniques in children. It's an efficient way to offer perioperative analgesia for painful sub-umbilical interventions but with high incidence of motor block and urinary retention. In one study, psoas compartment block was associated with less morphine comsumption and prolonged duration of analgesia compared to single-shot caudal Block in small children undergoing open hip reduction/osteotomies. Ultasound guided anterior Quadratus lumborum block (AQLB) provides unilateral analgesia to the nerves between the psoas muscle (PM) and the quadratus lumborum muscle (QLM). The first pediatric study evaluating Quadratus lumborum block is encouraging .
The first pediatric study evaluating Quadratus lumborum block is encouraging. To the best of the investigator's knowledge, there are no previously published data comparing the AQLB with other regional techniques in infants undergoing hip surgery.
Study Overview
Status
Intervention / Treatment
Detailed Description
The aim of this prospective randomized study was to compare the analgesic effects between AQLB and CB in children undergoing unilateral open hip reduction/osteotomies for hip dislocation.
Patients were randomly assigned, into 1 of 2 groups, namely, group CB (n = 20) and group AQLB (n = 20).
Preoperatively all children were premedicated by using oral midazolam (0 .5mg/kg).
anesthesia was induced with 3 to 4% sevoflurane and 50% with 60% nitrous oxide in oxygen.Then fentanyl 3 μg/kg and Propofol 1 - 2mg/Kg were administered for anesthesia induction. Airway was secured with endotracheal tube placed in the mouth facilited by 0.15 mg/kg cistracurium. Anesthesia maintenance was performed with sevoflurane 2% in 50% nitrous oxide.
AQLB and CB were done with 1 ml/kg, 0.25% Ropivacaine (maximum dose limited to 20 ml)
Postoperative follow-up:
All patients received 15 mg/kg paracetamol before extubation. Tramadol 2 mg/kg intravenous was planned as rescue analgesia when CHEOPS score was more than 3. Supplemental IV tramado, 1 mg/kg could be added if necessary every 6 hours.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Olfa kaabachi, MD
- Phone Number: +21698317381
- Email: olfa.kaabachi@gnet.tn
Study Locations
-
-
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Tunis, Tunisia, 2010
- Institut Kassab D'Orthopedie
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 2 to 7 years old
- Weight ≤ 20 Kg
- American Society of Anesthesiologists (ASA) physical status I or II
- Planned to undergo unilateral open hip reduction/osteotomies
Exclusion Criteria:
- Cerebral palsy with severe intellectual disability
- Coagulation disorders
- Local or general infection
- Allergy to amide local anesthetics.
- Progressive neurological disorders
- Parenteral refusal
- Spinal dysraphism
- Cutaneous anomalies (angioma, hair truft, naevus or a dimple)near to the puncture
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CAUDAL BLOCK
Sonosite machine (M-Turbo) equipped with a large bandwidth, a multifrequency linear probe (6-19 MHz) and needle of diameter and length respectively between 22G and 25G, 35mm and 40mm according to the child's size (Braun).The patient is positioned laterally with their hips flexed to 90°.
The sacral hiatus is forming with the two posterior superior iliac spines an equilateral triangle.
The puncture is performed between the two sacral cornuae.
The sacrococcygeal ligament gives a perceptible 'pop' when crossed.
After crossing the sacro-coccygeal ligament, the needle is redirected 30° to the skin surface, and then advanced a few millimeters into sacral canal.
After verifying absence of spontaneous reflux of blood or cerebrospinal fluid, slowly injection of Ropivacaine 0.25% 1ml/ kg
|
ultrasound guided caudal block with 1 ml/kg 0.2% ropivacaine
|
Experimental: anterior Quadratus lumborum block
Sonosite machine (M-Turbo) equipped with a large bandwidth, a multifrequency linear probe (6-19 MHz) and a 22G, 50-mm, insulated facet type needle (BBraun Stimuplex Ultra 360°).
Patients were placed in the lateral position, a probe was placed transversely to the abdominal flank.
The needle was inserted using an in-plane technique and was preceded further into the fascia between the QLM and PM.
Following confirmation of the correct space with the administration of 0.5-1 ml local anesthetic, block was induced with 1 ml/kg, 0.25% Ropivacaine,
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ultrasound anterior quadratum lumborum block with 1 ml/kg 0.2% ropivacaine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
analgesics consumption
Time Frame: day one
|
total tramadol consumption
|
day one
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative pain score
Time Frame: day one
|
Children's Hospital Eastern Ontario Pain Scale (CHEOPS) [4=no pain ; 13=worst pain]
|
day one
|
analgesic rescue
Time Frame: Day one
|
time to first analgesic rescue
|
Day one
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: khaireddine Raddaoui, MD, Tunis El Manar University
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE-IMKO 104/2019
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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