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

Ultrasound-Guided Lumbar Erector Spinae Plane Block Versus Caudal Block for Postoperative Analgesia in Hip and Proximal Femur Surgery in Pediatric Patients: A Prospective Randomized Controlled Study

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05157516
Enrollment
76
Registered
2021-12-15
Start date
2021-12-21
Completion date
2022-06-28
Last updated
2022-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

Brief 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

Interventions

PROCEDUREerector spinea block

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

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
No

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain score2 hours post-operativelyBy 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

Secondary

MeasureTime frameDescription
Block failure rateFirst hour postoperativelyThe block will be considered a failed block if the patient required more than two doses of rescue analgesia in the first hour postoperatively
Block performance timePreoperative
pain scoresat 2 hour intervals during the first 24 hours postoperativelyBy 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
Duration of the blockUP to 48 hours postoperatively
Degree of contralateral motor blockage and lower limb weaknessUP to 48 hours postoperativelyBy 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%)
The incidence of adverse effectsUp to one week after the block

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026