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Quadratus Lumborum Block for Pediatric Hip Surgery

Primary Purpose

Hip Dislocation, Congenital, Postoperative Pain, Anesthesia

Status
Unknown status
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
anterior Quadratus lumborum block
caudal block
Sponsored by
University Tunis El Manar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Dislocation, Congenital focused on measuring hip dislocation, regional anesthesia, surgery

Eligibility Criteria

2 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Kassab D'OrthopedieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CAUDAL BLOCK

anterior Quadratus lumborum block

Arm Description

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

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,

Outcomes

Primary Outcome Measures

analgesics consumption
total tramadol consumption

Secondary Outcome Measures

postoperative pain score
Children's Hospital Eastern Ontario Pain Scale (CHEOPS) [4=no pain ; 13=worst pain]
analgesic rescue
time to first analgesic rescue

Full Information

First Posted
February 23, 2020
Last Updated
June 16, 2020
Sponsor
University Tunis El Manar
Collaborators
Institut Kassab d'Orthopédie
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1. Study Identification

Unique Protocol Identification Number
NCT04292782
Brief Title
Quadratus Lumborum Block for Pediatric Hip Surgery
Official Title
Caudal Epidural Block Compared to Anterior Quadratus Lumborum Block for Pediatric Hip Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 31, 2020 (Actual)
Primary Completion Date
March 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Tunis El Manar
Collaborators
Institut Kassab d'Orthopédie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Dislocation, Congenital, Postoperative Pain, Anesthesia
Keywords
hip dislocation, regional anesthesia, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAUDAL BLOCK
Arm Type
Active Comparator
Arm Description
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
Arm Title
anterior Quadratus lumborum block
Arm Type
Experimental
Arm Description
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,
Intervention Type
Procedure
Intervention Name(s)
anterior Quadratus lumborum block
Intervention Description
ultrasound anterior quadratum lumborum block with 1 ml/kg 0.2% ropivacaine
Intervention Type
Procedure
Intervention Name(s)
caudal block
Intervention Description
ultrasound guided caudal block with 1 ml/kg 0.2% ropivacaine
Primary Outcome Measure Information:
Title
analgesics consumption
Description
total tramadol consumption
Time Frame
day one
Secondary Outcome Measure Information:
Title
postoperative pain score
Description
Children's Hospital Eastern Ontario Pain Scale (CHEOPS) [4=no pain ; 13=worst pain]
Time Frame
day one
Title
analgesic rescue
Description
time to first analgesic rescue
Time Frame
Day one

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olfa kaabachi, MD
Phone
+21698317381
Email
olfa.kaabachi@gnet.tn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
khaireddine Raddaoui, MD
Organizational Affiliation
Tunis El Manar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Kassab D'Orthopedie
City
Tunis
ZIP/Postal Code
2010
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olfa kaabachi
Phone
98317381

12. IPD Sharing Statement

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Quadratus Lumborum Block for Pediatric Hip Surgery

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