NCT05282849

Brief Summary

Comparison between ultrasound guided transmuscular QL block and Fascia iliaca block in pediatric patients undergoing DDH surgery regarding the quality of pain control in the perioperative period..

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

April 4, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

2 months

First QC Date

March 8, 2022

Last Update Submit

April 8, 2022

Conditions

Keywords

ultrasoundquadratus lumborumfascia iliaca

Outcome Measures

Primary Outcomes (1)

  • Total 12 hours postoperative opioid consumption

    amount of morphine consumed as rescue analgesia in first 12 hours

    from the time of transfer of the patient to the pacu at one hour intervals for 12 hours

Secondary Outcomes (3)

  • Postoperative pain using Face, Legs, Activity, Cry, Consolability scale (FLACC ) pain rating scale

    from the time of transfer to the PACU, every hour for the first 24 hours postoperative]

  • Side effects

    from the time of transfer to the PACU, for the first 24 hours postoperative

  • Total 24 hours postoperative opioid consumption

    from the time of transfer of the patient to the pacu at one hour intervals for 24hours

Study Arms (2)

Group F: ultrasound guided fascia iliaca block group

ACTIVE COMPARATOR
Procedure: ultrasound guided fascia iliaca block

Group Q: ultrasound guided quadratus lumborum block group

ACTIVE COMPARATOR
Procedure: ultrasound guided quadratus lumborum block

Interventions

ultrasound guided fascia iliaca block anesthetizes variable combinations of the femoral nerve , lateral femoral cutaneous nerve , and obturator nerve, and is effective for many painful hip surgeries making it potentially useful for analgesia following Developmental Dysplasia of Hip (DDH) surgery.

Group F: ultrasound guided fascia iliaca block group

ultrasound-guided quadratus lumborum (QL) block provides perioperative somatic, even visceral analgesia for patients including pediatrics, undergoing abdominal or hip surgery. The local anesthetic injected adjacently into the quadrates lumborum muscle spreads in a medial and cranial direction under the crura and arcuate ligaments of the diaphragm, then into the thoracic paravertebral space anesthetizing the hip region

Group Q: ultrasound guided quadratus lumborum block group

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 2-12 years
  • Of both sexes
  • American society of anesthesiologist (ASA) physical status classification class I
  • Undergoing general anaesthesia for DDH surgery

You may not qualify if:

  • Parents' refusal of regional block
  • Duration of surgery over 120 min.
  • History of allergy to local anesthetics
  • Bleeding disorders (INR \>1.4, Platelet count\< 75000)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine Cairo university

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Developmental Dysplasia of the Hip

Condition Hierarchy (Ancestors)

Hip DislocationJoint DislocationsJoint DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

March 8, 2022

First Posted

March 16, 2022

Study Start

April 4, 2022

Primary Completion

June 1, 2022

Study Completion

June 15, 2022

Last Updated

April 15, 2022

Record last verified: 2022-04

Locations