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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05444309
Other study ID # 22-6-2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2022
Est. completion date July 10, 2023

Study information

Verified date July 2023
Source Zagazig University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date July 10, 2023
Est. primary completion date May 1, 2023
Accepts healthy volunteers No
Gender All
Age group 2 Years to 6 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Quadratus lumborum (QL) block group
patient will receive 0.5 mg/kg of bupivacaine 0.25% through the quadratus lumborum block approach
Pericapsular Nerve Group (PENG) block group
patient will receive 0.5 mg/kg of bupivacaine 0.25% through the Pericapsular Nerve Group (PENG) block

Locations

Country Name City State
Egypt faculty of medicine, Zagazig university Zagazig Elsharqya

Sponsors (1)

Lead Sponsor Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: BJA Educ. 2020 Jan;20(1):32. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Pain assessment using Modified Objective Pain Scale (MOPS) a scale of 0-10, where 0= No pain and 10= Maximum worst pain. immediately postoperative and then at 2, 4, 6, 12 & 24 hours after surgery
Secondary total amount of post-operative rescue analgesia needed total amount of post-operative rescue analgesia in the form of ibuprofen syrup needed in the first postoperative 24 hours
See also
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Completed NCT01015053 - Postoperative Pain After Pediatric Umbilical Hernia Repair N/A