PENG Block vs. ESP Block for Pediatric Hip Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-17

Study Completion Date

2024-02-23

Brief Summary

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The study compares the effectiveness and safety of the pericapsular nerve blockade vs. ESPB in pediatric patients who underwent hip surgeries.

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Detailed Description

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The study compares the effectiveness and safety of the pericapsular nerve blockade vs. ESPB in pediatric patients who underwent hip surgeries. In addition, we aim to determine the optimal volume of local anesthetics needed to achieve a satisfactory level of analgesia.

Conditions

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Hip Dysplasia Hip Injuries Hip Fractures Hip Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three groups:

Group I -control Group II - PENG block Group III - ESP block

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Patients will be randomly allocated to receive ultrasound-guided PENG block, ESP block, or only spinal anesthesia by computer software 1:1:1. A researcher who will not involve in the study will prepare the randomization list and concealed group assignments in consecutively numbered, sealed, opaque envelopes. A consultant anesthesiologist will follow management to open the envelopes shortly before the nerve block performance to reveal the group allocation and perform the procedure according to the assignment. The patients and their anesthesia team, surgeon, operating room staff, and parents will be masked to the study group allocation. Group blinding unmasking will only occur once the statistical analysis is complete.

Study Groups

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Control group

regional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type OTHER

No erector spinae block and no pericapsular nerve group block

Pericapsular nerve group block (PENG) group

regional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine + PENG block - 0.5mL/kg 0.2% ropivacaine, max. 20mL

Group Type ACTIVE_COMPARATOR

Pericapsular nerve group block using 0.2% ropivacaine

Intervention Type DRUG

Unilateral ultrasound guided pericapsular nerve block using 0.5mL/kg 0.2% Ropimol (max 20mL)

Erector Spinae Plane Block (ESPB) group

regional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine + ESP block - 0.5mL/kg 0.2% ropivacaine, max. 20mL

Group Type ACTIVE_COMPARATOR

Erector Spinae Plane Block using 0.2% ropivacaine

Intervention Type DRUG

Unilateral ultrasound guided erector spinae block using 0.5mL/kg 0.2% Ropimol (max 20mL)

Interventions

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Pericapsular nerve group block using 0.2% ropivacaine

Unilateral ultrasound guided pericapsular nerve block using 0.5mL/kg 0.2% Ropimol (max 20mL)

Intervention Type DRUG

Erector Spinae Plane Block using 0.2% ropivacaine

Unilateral ultrasound guided erector spinae block using 0.5mL/kg 0.2% Ropimol (max 20mL)

Intervention Type DRUG

Standard care

No erector spinae block and no pericapsular nerve group block

Intervention Type OTHER

Other Intervention Names

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No erector spinae block and no pericapsular nerve group block

Eligibility Criteria

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Inclusion Criteria

\- pediatric patients aged between 0-12 years who will undergo hip surgery

Exclusion Criteria

* a history of chronic pain use of gabapentin/pregabalin for \> 3 months opioid use \> 1 repeated opioid prescription in the last three months
* morbid obesity (BMI \> 99th percentile)
* Infection at block application area
* coagulopathy

Minimum Eligible Age

2 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No