Quadratus Lumborum Block for Pediatric Hip Surgery

NCT ID: NCT04292782

Last Updated: 2024-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-31

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hip Dislocation, Congenital Postoperative Pain Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

caudal block

Intervention Type PROCEDURE

ultrasound guided caudal block with 1 ml/kg 0.2% ropivacaine

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,

Group Type EXPERIMENTAL

anterior Quadratus lumborum block

Intervention Type PROCEDURE

ultrasound anterior quadratum lumborum block with 1 ml/kg 0.2% ropivacaine

Interventions

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anterior Quadratus lumborum block

ultrasound anterior quadratum lumborum block with 1 ml/kg 0.2% ropivacaine

Intervention Type PROCEDURE

caudal block

ultrasound guided caudal block with 1 ml/kg 0.2% ropivacaine

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Kassab d'Orthopédie

OTHER

Sponsor Role collaborator

University Tunis El Manar

OTHER

Sponsor Role lead

Responsible Party

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Olfa kaabachi, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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khaireddine Raddaoui, MD

Role: PRINCIPAL_INVESTIGATOR

Tunis El Manar University

Locations

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Institut Kassab D'Orthopedie

Tunis, , Tunisia

Site Status

Countries

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Tunisia

Other Identifiers

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CE-IMKO 104/2019

Identifier Type: -

Identifier Source: org_study_id

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