NCT04292782

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 23, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

March 31, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

12 months

First QC Date

February 23, 2020

Last Update Submit

February 11, 2024

Conditions

Keywords

hip dislocationregional anesthesiasurgery

Outcome Measures

Primary Outcomes (1)

  • analgesics consumption

    total tramadol consumption

    day one

Secondary Outcomes (2)

  • postoperative pain score

    day one

  • analgesic rescue

    Day one

Study Arms (2)

CAUDAL BLOCK

ACTIVE COMPARATOR

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

Procedure: caudal block

anterior Quadratus lumborum block

EXPERIMENTAL

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,

Procedure: anterior Quadratus lumborum block

Interventions

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

anterior Quadratus lumborum block
caudal blockPROCEDURE

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

CAUDAL BLOCK

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Kassab D'Orthopedie

Tunis, 2010, Tunisia

Location

MeSH Terms

Conditions

Hip Dislocation, CongenitalPain, PostoperativeHip Dislocation

Condition Hierarchy (Ancestors)

Developmental Dysplasia of the HipMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsJoint DislocationsJoint DiseasesWounds and InjuriesHip Injuries

Study Officials

  • khaireddine Raddaoui, MD

    Tunis El Manar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 23, 2020

First Posted

March 3, 2020

Study Start

March 31, 2020

Primary Completion

March 30, 2021

Study Completion

December 31, 2021

Last Updated

February 13, 2024

Record last verified: 2024-02

Locations