Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202204798992849 Date of Approval: 19/04/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparing two different paediatric regional anesthesia techniques for postoperative analgesia after surgical correction of developmental dysplasia of the hip joint
Official scientific title Comparing the postoperative analgesic efficiency of trans-muscular Quadratus Lumborum Block Versus PENG Block for Hip Surgery in Pediatrics: A Randomized controlled clinical trial
Brief summary describing the background and objectives of the trial Orthopaedic interventions including open hip joint surgery for developmental dysplasia of the hip (DDH) after failed conservative management are one of the most frequently done paediatric surgeries in children and they are extremely painful due to the multiple osteotomies and tenotomies and associated with considerable postoperative pain despite the use of systemic opioids. The objective of the current trial is primarily to assess the analgesic efficacy of ultrasound-guided trans-muscular QL block versus ultrasound-guided PENG block in paediatric patients undergoing open hip surgery for DDH. The secondary aim is to assess the safety of both techniques and the ease of performance
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Orthopaedics,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial decrease pain after surgery and early ambulation
Anticipated trial start date 18/04/2022
Actual trial start date
Anticipated date of last follow up 02/01/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Transmuscular Quadratus lumborum TQL block 0.5 ml/kg of 0.25% bupivacaine single injection after induction of general anesthesia The participant will be placed in the lateral position with the side to be operated upon directed upward, then after sterilization of the area of the hip joint with chlorhexidine 0.5% in ethanol 82%, a high-frequency linear ultrasound probe (5-13 MHz) (FUJIFILM SonoSite, Bothell, Washington, USA) will be covered with a sterile cover and placed on the anterior iliac crest. The Petit’s triangle (formed of the iliac crest inferiorly and the borders of external abdominal oblique anteriorly and latissimus dorsi (LD) posteriorly) will be identified and then Tracing dorsally from Petit's triangle, the external oblique, and the internal oblique are seen disappearing into an aponeurosis as the QL appears beneath the LD (anteriorly), and going farther dorsally, the shamrock appearance of the QL, erector spinae, and psoas major muscles (the 3 leaves) around the transverse process of lumbar vertebra L4 (as the stem) are seen. A 22-gauge Quincke-type Sono-Plex needle (Pajunk, Geisingen, Germany) will be inserted using an in-plane technique along the posterior edge of the probe in the anteromedial direction. The needle tip will be placed between the QL muscle and the PM muscle. After confirming the correct position of the needle by injecting 2 ml of normal saline with a hydro-dissection image, 0.5 ml/kg of 0.25% bupivacaine will be injected. The injected local anesthetic bolus then will be seen pushing the PM away from the QL 20
Experimental Group Pericapsular Nerve Group PENG block 0.5 ml/kg of 0.25% bupivacaine single injection after induction of general anesthesia The regional block will be performed with the participant in the supine position. A linear high-frequency ultrasound probe (5–13MHz) was initially placed in a transverse plane over the anterior inferior iliac spine (AIIS) and then aligned with the pubic ramus by rotating the probe counter clockwise approximately 45 degrees; In this view, the ilio-pubic eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed. A 22-gauge, 80-mm 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. Following negative aspiration, the local anesthetic solution of 0.25% bupivacaine will be injected in 5-mL increments while observing for an adequate fluid spread in this plane for a total volume of 0.5 ml/kg 20
Control Group no control group not done not done 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American society association (ASA) physical status class I - II Participants who will be scheduled for an elective unilateral open hip surgery for correction of DDH under general anesthesia Respiratory disease, renal or hepatic insufficiency. Infection of the skin in the puncture area. Coagulopathy. Allergy against any of the drugs to be used (bupivacaine). Neuromuscular disease. Obesity (body mass index, BMI >30). Bilateral hip surgery or previous hip surgery. Recent previous analgesic medication intake or chronic pain on regular treatment. Previously known neurological pathologies or central nervous system disorders Preschool Child: 2 Year-5 Year 1 Year(s) 6 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/02/2022 scientific ethical committee
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine Alexandria University, 17 Champollion street, El Messalah Alexandria 21568 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the time until the first rescue analgesic requirement postoperatively During the first 48 hours postoperatively
Secondary Outcome Face, Leg, Activity, Cry, and Consolability FLACC score 2hrs, 4hrs, 8hrs, 12hrs, 24hrs, 48hrs postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria university hospitals Alhadra university orthopaedic hospital Alhadra, Italian hospital street Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria University Hospitals 17 Champollion Street, El Messalah Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Faculty of Medicine Alexandria University Hospitals El Messalah, 17 Champollion street Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hisham Gamal Eldine hesham.gamal@alexmed.edu.eg +201006665018 Bolkly
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of anesthesia and surgical intensive care faculty of medicine Alexandria University
Role Name Email Phone Street address
Scientific Enquiries Ahmed Elnaggar a_elnajjar00@alexmed.edu.eg +201005101836 Smouha
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of anesthesia and surgical intensive care faculty of medicine Alexandria University
Role Name Email Phone Street address
Public Enquiries Hisham Gamal Eldine hesham.gamal@alexmed.edu.eg +201006665018 Bolkly
City Postal code Country Position/Affiliation
Alexandria Egypt lecturer of anesthesia Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol Beginning 9 months and ending 36 months following article publication For individual participant meta-analysis
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information