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CompletedNCT05157516Updated Jul 18, 2022

Ultrasound-Guided Lumbar Erector Spinae Plane Block Versus Caudal Block for Postoperative Analgesia in Hip and Proximal Femur Surgery in Pediatric Patients

A Phase 3 interventional study of erector spinea block and Caudal epidural block in Post Operative Pain, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 1 Year to 7 Years. Per ClinicalTrials.gov, last updated 2022-07-18.

Sponsored by Cairo University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
1 Year to 7 Years
Sex
All
01

Study summary

The study will compare Ultrasound-Guided Lumbar Erector Spinae Plane Block and caudal block for Postoperative Analgesia in Hip and Proximal Femur Surgery in pediatric patients

02

Conditions studied

  • Post Operative Pain

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 76 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

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Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ASA I-II.
  • Scheduled to undergo hip or proximal femur surgeries.

Exclusion criteria

Exclusion Criteria:

  • Refusal of participation by parents or caregivers
  • Known local anesthetic (LA) drug sensitivity
  • Bleeding disorders with INR > 1.5 and/or platelets \< 100,000/mm3.
  • Skin lesions or wounds at the site of proposed needle insertion.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
76 participants (actual)

Study arms

  • Active comparator
    group ESPB

    Erector Spinae Plane Block

    Procedure: erector spinea block

  • Active comparator
    In group CEA

    Caudal epidural block

    Procedure: Caudal epidural block

Interventions

  • Procedureerector spinea block

    the patients will receive a single injection erector spinea block after induction of general anesthesia

  • ProcedureCaudal epidural block

    the patients will receive caudal epidural block after induction of general anesthesia

06

What researchers measure

Primary outcomes

  1. Pain score

    By using face, legs, activity, and cry consolability scale \[FLACC \] FLACC scale will be measured as following: Each category (face,legs,activity, and cry consolability) is scored on the 0-2 scale which results in a total score of 0-10. Assessment of the final score: 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain

    Time frame: 2 hours post-operatively

Secondary outcomes

  1. pain scores

    By using face, legs, activity, and cry consolability scale \[FLACC \] FLACC scale will be measured as following: Each category (face,legs,activity, and cry consolability) is scored on the 0-2 scale which results in a total score of 0-10. Assessment of the final score: 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain

    Time frame: at 2 hour intervals during the first 24 hours postoperatively

  2. Block failure rate

    The block will be considered a failed block if the patient required more than two doses of rescue analgesia in the first hour postoperatively

    Time frame: First hour postoperatively

  3. Block performance time

    Time frame: Preoperative

  4. The incidence of adverse effects

    Time frame: Up to one week after the block

  5. Duration of the block

    Time frame: UP to 48 hours postoperatively

  6. Degree of contralateral motor blockage and lower limb weakness

    By using modified bromage scale as following: Grade I : Free movement of legs and feet Degree of block :Nil (0%) Grade II :Just able to flex knees with free movement of feet Degree of block :Partial (33%) Grade III :Unable to flex knees, but with free movement of feet Degree of block: Almost complete (66%) Grade IV :Unable to move legs or feet Degree of block: Complete (100%)

    Time frame: UP to 48 hours postoperatively

07

Study locations

1 site
  • Kasr Alaini hospital
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05157516
Lead sponsor
Cairo University
Responsible party
AbdElKhalik Mahmoud Shaban (Lecturer of anaesthesia, Cairo University) — Principal investigator
First posted
Dec 15, 2021
Start date
Dec 21, 2021
Primary completion
Jun 2, 2022
Completion
Jun 28, 2022
Last update
Jul 18, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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