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NCT Number: NCT05157516

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

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

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kasr Alaini hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

erector spinea block

Procedure

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

Caudal Epidural Block

Procedure

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

Primary outcomes

  1. Pain score

    Time frame: 2 hours post-operatively

    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

Secondary outcomes

  1. pain scores

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

    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

  2. Block failure rate

    Time frame: First hour postoperatively

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

    Time frame: UP to 48 hours postoperatively

    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%)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 15, 2021
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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