Ultrasound Guided Pericapsular Nerve Group Block Versus Quadratus Lumborum Block

NCT ID: NCT05444309

Last Updated: 2023-07-14

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-07-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Developmental dysplasia of the hip (DDH) is a common disease of the pediatrics patients with a rate of incidence 3 to 5 per 1000 children and open surgical reduction of congenital hip dislocation (CHD) is commonly done in paediatrics.

One of the most important challenges in pediatric hip surgeries is postoperative pain management which may result in impaired patient rehabilitation and prolonged hospitalizations.

Opioids are commonly used for postoperative analgesia in various surgeries but their use is associated with many complications such as sedation, dizziness, nausea, vomiting, constipation and respiratory depression. Many types of peripheral nerve blocks, such as the femoral nerve block (FNB) and the lumbar plexus block (LPB), are used for lower limb surgeries as well as anterior quadratus lumborum block (QLB) and Pericapsular nerve group (PENG) block that provide effective postoperative analgesia in lower limb surgeries.

Quadratus Lumborum (QL) block was first described by Rafael Blanco at the 2007 annual meeting of the European Society of Regional Anesthesia (ESRA). The basic concept of the QL block is the deposition of a local anesthetic solution adjacent to the anterolateral aspect of the QL muscle. The spread pattern obtained is similar to that of the landmark-based TAP block, in that there is subsequent extension into the thoracic paravertebral space. Borglum et al. originally described placing the needle tip anterior to the QL muscle using their transmuscular approach.

This technique was later refined by applying a posterior approach, named the "Shamrock method" (with the erector spinae, QL, and psoas muscles as the leaves and the L4 transverse process as the stem). Administering local anesthesia between the QL and psoas muscles ensures a reliable spread into the thoracic paravertebral space.

There are different quadratus lumborum blocks (anterior, posterior and lateral blocks) with different mechanisms of action according to injectate spread. However, there is insufficient evidence to recommend one approach and transducer positioning over another for individual patient populations and specific surgical types.

Pericapsular nerve group (PENG) block is relatively a recent regional technique based on blocking the articular branches to the hip joint with a single injection and is used for perioperative analgesia in hip surgery.

The pericapsular nerve group block (PENG) is a regional anesthetic technique described in 2018, developed primarily in total hip arthroplasties (THA) for postoperative analgesia with motor sparing benefits. The block is thought to provide more complete analgesia to the hip by depositing local anesthetic within the myofascial plane of the psoas muscle and superior pubic ramus.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pediatric Postoperative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients will be divided randomly by a computer-generated randomization table into three equal groups
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Quadratus lumborum block group

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.

Group Type ACTIVE_COMPARATOR

Quadratus lumborum (QL) block group

Intervention Type PROCEDURE

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

Pericapsular Nerve Group (PENG) block group

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.

Group Type ACTIVE_COMPARATOR

Pericapsular Nerve Group (PENG) block group

Intervention Type PROCEDURE

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

control group

The child will not receive any block.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quadratus lumborum (QL) block group

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

Intervention Type PROCEDURE

Pericapsular Nerve Group (PENG) block group

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

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Group Q Group P

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rehab Abd-Allah Wahdan

lecturer of anesthesia and surgical intensive care

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

faculty of medicine, Zagazig university

Zagazig, Elsharqya, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 9917445 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27033707 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32024551 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28154824 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30688787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30063657 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33456856 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31022606 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

22-6-2022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.