PENG Block vs. ESP Block for Pediatric Hip Surgery

Sponsor

Poznan University of Medical Sciences (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06087549

Collaborator

(none)

150

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hip Dysplasia Hip Injuries Hip Fractures Hip Disease	Drug: Pericapsular nerve group block using 0.2% ropivacaine Drug: Erector Spinae Plane Block using 0.2% ropivacaine Other: Standard care	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Three groups: Group I -control Group II - PENG block Group III - ESP blockThree groups:Group I -control Group II - PENG block Group III - ESP block

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

PENG Block vs. ESP Block for Pediatric Hip Surgery. A Randomized, Prospective Double-blinded Clinical Trial.

Anticipated Study Start Date :

Nov 30, 2023

Anticipated Primary Completion Date :

Dec 20, 2023

Anticipated Study Completion Date :

Jan 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control group regional anesthesia: spinal anesthesia - 0,1ml/kg 0,5% ropivacaine	Other: Standard care No erector spinae block and no pericapsular nerve group block Other Names: No erector spinae block and no pericapsular nerve group block
Active Comparator: 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	Drug: Pericapsular nerve group block using 0.2% ropivacaine Unilateral ultrasound guided pericapsular nerve block using 0.5mL/kg 0.2% Ropimol (max 20mL)
Active Comparator: 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	Drug: Erector Spinae Plane Block using 0.2% ropivacaine Unilateral ultrasound guided erector spinae block using 0.5mL/kg 0.2% Ropimol (max 20mL)

Arm

Intervention/Treatment

Active Comparator: Control group

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

Other: Standard care

No erector spinae block and no pericapsular nerve group block

Other Names:

No erector spinae block and no pericapsular nerve group block

Active Comparator: 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

Drug: Pericapsular nerve group block using 0.2% ropivacaine

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

Active Comparator: 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

Drug: Erector Spinae Plane Block using 0.2% ropivacaine

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

Outcome Measures

Primary Outcome Measures

FLACC score [48 hours after surgery]
The FLACC scale or Face, Legs, Activity, Cry, Controllability Scale is used to assess pain for children between the ages of 2 months and seven years or individuals unable to communicate their pain. The scale is scored in a range of 0-10, with 0 representing no pain.

Secondary Outcome Measures

NLR [48 hours after surgery]
neutrophil-to-lymphocyte ratio
PLR [48 hours after surgery]
platelet-to-lymphocyte ratio
total opioid consumption [48 hours after surgery]
morphine equivalents in miligrams

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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