Ultrasound Guided Pericapsular Nerve Group Block Versus Quadratus Lumborum Block

NCT05444309 | Completed

• 1 other identifier: 22-6-2022
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Hip surgeries in pediatrics consider as one of the common nowadays surgeries with sever postoperative pain so pain management is essential to decrease postoperative complications, early mobilization and hospital discharge. Traditional use of opioids is associated with many adverse effects such as sedation, dizziness, nausea, vomiting, constipation and respiratory depression. Previous studies reported that Quadratus Lumborum (QL) Block and Pericapsular Nerve Group (PENG) Block are effective postoperative analgesia in hip surgeries. In this study we will compare between QL block and PENG Block for effective postoperative analgesia to reduce opioids consumption and subsequently avoid opioid-related adverse effects, early mobilization and early hospital discharge.

Conditions

Pediatric Postoperative Pain

Keywords

Pericapsular Nerve Group Block; Quadratus Lumborum Block; postoperative analgesia; pediatric hip surgeries

Outcome Measures

Primary Outcomes (1)

• duration of sensory block

  It is the time from the end of block performance till the first patient's complain of pain

  within 24 hour postoperative

Secondary Outcomes (2)

• Pain assessment

  immediately postoperative and then at 2, 4, 6, 12 & 24 hours after surgery

• total amount of post-operative rescue analgesia needed

  in the first postoperative 24 hours

Study Arms (3)

Quadratus lumborum block group

ACTIVE COMPARATOR

The child will be positioned in the lateral position, with the operative side non-dependent. Under complete aseptic precautions, QL block will be given by anterior approach at the level of L4. A linear high-frequency probe of Sonosite M Turbo ultrasonography will be applied vertically above the iliac crest, and a 22G, 80 mm spinal needle will be inserted in the plane from the posterior edge of the probe through the QL muscle in an anteromedial direction. The needle tip will be placed between the Psoas major (PM) muscle and the QL muscle. After negative aspiration, injection of 0.5 mL of normal saline to the space between PM and QL muscles . An injection of 0.5 mg/kg of 0.25% bupivacaine into the fascial plane and the local anesthetic appears to press down the PM muscle in the ultrasound image, the patients will be repositioned to a supine position immediately after the block.

Procedure: Quadratus lumborum (QL) block group

Pericapsular Nerve Group (PENG) block group

ACTIVE COMPARATOR

PENG block will be done while the child in supine position. Then, a high-frequency (8-15 MHz) ultrasound linear probe of Sonosite M Turbo ultrasonography (FUJIFILM Sonosite, Inc., Bothell, WA, USA) will be placed over the anterosuperior iliac spine and then rotating it 45 degrees to acquire images from lateral to medial of the anterior inferior iliac spine, iliopubic eminence, psoas tendon, and the femoral artery. Then, a 22G, 80 mm spinal needle will be inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. After negative aspiration and a test does (0.5 mL of normal saline), an injection of 0.5 mg/kg of 0.25% bupivacaine into the space between the psoas tendon and the iliopubic eminence.

Procedure: Pericapsular Nerve Group (PENG) block group

control group

NO INTERVENTION

The child will not receive any block.

Interventions

Quadratus lumborum (QL) block group PROCEDURE

patient will receive 0.5 mg/kg of bupivacaine 0.25% through the quadratus lumborum block approach

Also known as: Group Q

Quadratus lumborum block group

Pericapsular Nerve Group (PENG) block group PROCEDURE

patient will receive 0.5 mg/kg of bupivacaine 0.25% through the Pericapsular Nerve Group (PENG) block

Also known as: Group P

Pericapsular Nerve Group (PENG) block group

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Physical status: ASA I-II
• Scheduled for open unilateral hip surgery

You may not qualify if:

• Parent's refusal
• Allergy to local anesthetics drugs
• Psychological, mental disorders or metabolic disease
• Patients with bleeding disorder, liver disease or sepsis
• Local infection or pervious surgery at site of anesthetic injection procedures.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

faculty of medicine, Zagazig university

Zagazig, Elsharqya, 44519, Egypt

Location

Related Publications (8)

• Bialik V, Bialik GM, Blazer S, Sujov P, Wiener F, Berant M. Developmental dysplasia of the hip: a new approach to incidence. Pediatrics. 1999 Jan;103(1):93-9. doi: 10.1542/peds.103.1.93.

  PMID: 9917445 BACKGROUND

• Gurkan Y, Aksu C, Kus A, Toker K, Solak M. One operator's experience of ultrasound guided lumbar plexus block for paediatric hip surgery. J Clin Monit Comput. 2017 Apr;31(2):331-336. doi: 10.1007/s10877-016-9869-x. Epub 2016 Mar 31.

  PMID: 27033707 BACKGROUND

• Kikuchi M, Mihara T, Mizuno Y, Fujimoto H, Arai S, Nomura T, Goto T. Anterior quadratus lumborum block for postoperative recovery after total hip arthroplasty: a study protocol for a single-center, double-blind, randomized controlled trial. Trials. 2020 Feb 5;21(1):142. doi: 10.1186/s13063-020-4090-0.

  PMID: 32024551 BACKGROUND

• Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.

  PMID: 28154824 BACKGROUND

• Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.

  PMID: 30688787 BACKGROUND

• Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.

  PMID: 30063657 BACKGROUND

• Merella F, Canchi-Murali N, Mossetti V. General principles of regional anaesthesia in children. BJA Educ. 2019 Oct;19(10):342-348. doi: 10.1016/j.bjae.2019.06.003. Epub 2019 Aug 24. No abstract available.

  PMID: 33456856 BACKGROUND

• Orozco S, Munoz D, Jaramillo S, Herrera AM. Pediatric use of Pericapsular Nerve Group (PENG) block for hip surgical procedures. J Clin Anesth. 2019 Nov;57:143-144. doi: 10.1016/j.jclinane.2019.04.010. Epub 2019 Apr 22. No abstract available.

  PMID: 31022606 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and surgical intensive care

Model Details: The patients will be divided randomly by a computer-generated randomization table into three equal groups

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: August 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: July 10, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: planned after the completion of the study and publication
• Access Criteria: principal investigator

Locations

EG (1)