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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04292782
Other study ID # CE-IMKO 104/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 31, 2020
Est. completion date December 31, 2021

Study information

Verified date February 2024
Source University Tunis El Manar
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 31, 2021
Est. primary completion date March 30, 2021
Accepts healthy volunteers No
Gender All
Age group 2 Years to 7 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
anterior Quadratus lumborum block
ultrasound anterior quadratum lumborum block with 1 ml/kg 0.2% ropivacaine
caudal block
ultrasound guided caudal block with 1 ml/kg 0.2% ropivacaine

Locations

Country Name City State
Tunisia Institut Kassab D'Orthopedie Tunis

Sponsors (2)

Lead Sponsor Collaborator
University Tunis El Manar Institut Kassab d'Orthopédie

Country where clinical trial is conducted

Tunisia, 

Outcome

Type Measure Description Time frame Safety issue
Primary analgesics consumption total tramadol consumption day one
Secondary postoperative pain score Children's Hospital Eastern Ontario Pain Scale (CHEOPS) [4=no pain ; 13=worst pain] day one
Secondary analgesic rescue time to first analgesic rescue Day one
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