Ultrasound Guided Pericapsular Nerve Group Block Versus Ultrasound Guided Caudal Block for Postoperative Pain in Paediatric Hip Surgery

NCT05981781 | Unknown

• 1 other identifier: 0107623
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study is to evaluate postoperative analgesic effect of ultrasound guided PENG block in comparison to ultrasound guided caudal epidural anaesthesia for hip surgeries in paediatrics

Conditions

Postoperative Pain in Paediatric Hip Surgery; PENG Block; Caudal Block

Keywords

PENG block; caudal block; hip surgery; postoperative pain

Outcome Measures

Primary Outcomes (1)

• postoperative opioid consumption

  compare between both groups as regard postoperative opioid consumption

  24 hours

Secondary Outcomes (5)

• postoperative analgesia

  24 hours

• duration of postoperative analgesia

  24 hours

• heamodynamics

  24 hours

• incidence of complications

  24 hours

• parent satisfaction

  24 hours

Other Outcomes (1)

• heamodynamics

  24 hours

Study Arms (2)

ultrasound guided peng block in paediatric hip surgery

ACTIVE COMPARATOR

Patients will receive US-guided PENG block with 0.5 ml/kg of bupivacaine 0.25% after induction of general anaesthesia.

Procedure: ultrasound guided peng block in paediatric hip surgery

ultrasound guided caudal epidural block in paediatric hip surgery

ACTIVE COMPARATOR

Patients will receive US-guided caudal block with 0.5 ml/kg of bupivacaine 0.25% after induction of general anaesthesia.

Procedure: ultrasound guided caudal epidural block in paediatric hip surgery

Interventions

ultrasound guided peng block in paediatric hip surgery PROCEDURE

On the supine position, under strict aseptic technique, a linear, high-frequency transducer (5-13 MHz) of a Sonosite (M-Turbo; Sonosite Inc, Bothell, W, USA) portable US machine will be placed in the transverse plane along the anterior inferior iliac spine (AIIS) to identify the iliopsoas muscle, femoral artery, and femoral nerve. The probe will be then rotated, and aligned with the pubic ramus to visualize the AIIS, iliopubic eminence (IPE), femoral artery, psoas muscle, and the superior pubic ramus. Under direct visualization, a needle will be advanced in-plane, lateral to medial between the psoas tendon and pubic ramus until the needle contacts the IPE. The needle will be slightly withdrawn, and following negative aspiration, 0.5 ml/kg of bupivacaine 0.25% will be injected.

ultrasound guided peng block in paediatric hip surgery

ultrasound guided caudal epidural block in paediatric hip surgery PROCEDURE

On lateral decubitus position, under strict aseptic technique, the sacral hiatus will be visualized at the level of the sacral cornua by employing a linear, high-frequency transducer (5-13 MHz) of a Sonosite (M-Turbo; Sonosite Inc, Bothell, W, USA) portable US machine will be placed transversely at the midline to obtain a transverse view of the two cornua, sacrococcygeal ligament, sacral bone, and sacral hiatus. At this level, the ultrasound transducer will be rotated to 90 degree to obtain longitudinal views of the sacrococcygeal ligament and sacral hiatus and subsequently placed between the two cornua. A needle will be advanced toward the upper third of the sacrococcygeal ligament. The needle advancement will be terminated immediately after penetrating the sacrococcygeal ligament. (17) At this level, after confirming absence of blood or cerebrospinal fluid on aspiration, bupivacaine 0.25% (0.5 mL/kg) will be injected over 1 minute while observing an ultrasound longitudinal image.

ultrasound guided caudal epidural block in paediatric hip surgery

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• paediatric patients belonging to American society of anesthesiologists (ASA)class1 or 2, aged 2-8 years scheduled for hip surgery

You may not qualify if:

• parent refusal skin infection at site of injection bleeding disorder or receiving anticoagulants history of allergy or contraindicaion to local anaesthetics neurological disease as cerebral palsy

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine

Alexandria, Alexandria, Egypt, 21111, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Rabab Saber, professor

  Alexandria University

  STUDY DIRECTOR

• Aly Mahmoud, lecturer

  Alexandria University

  STUDY DIRECTOR

• Ahmed Mansour, professor

  Alexandria University

  STUDY DIRECTOR

• yomna Said, MBBCH

  Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yomna Said, MBBCH

CONTACT

01065677956; yomna.said7@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: the patients , outcome assessors and care providers are not informed with the block type done.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blinded randomized study

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: August 8, 2023
• Study Start: May 15, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2024
• Last Updated: August 8, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: before the start till publishing the study
• Access Criteria: not public only researchers who can access study information

Locations

EG (1)