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Pain, PostoperativeTQLNCT05349656

Efficacy and Safety of Quadratus Lumborum Block Versus Pericapsular Nerve Group Block in Pediatric Hip Surgery

A study testing TQL block and PENG block in people with Pain, Postoperative and Developmental Dislocation of Hip, run by Alexandria University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Surgical procedure including hip joint surgery is extremely painful and associated with considerable postoperative pain in children despite the use of systemic opioids. Caudal block is a common method used for perioperative pain relief in pediatric lower limb surgeries but carries some complications. Read more about this study

Who is it for?
Ages 1 year to 6 years
What is being tested?
TQL block and PENG block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
6 May 2022to 25 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • Participants with 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).
Show all 9Show fewer
  • Previous hip surgery.
  • Previous analgesic medication, chronic pain.
  • Previously known neurological pathologies or central nervous system disorders

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Alexandria University

    Alexandria

Other trials in Egypt

About this study

Official 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

Surgical procedure including hip joint surgery is extremely painful and associated with considerable postoperative pain in children despite the use of systemic opioids.

Caudal block is a common method used for perioperative pain relief in pediatric lower limb surgeries but carries some complications.

Read more

Some novel techniques of regional anesthesia were explored including the quadratus lumborum block (QLB), lumbar plexus block, and recently Pericapsular nerve group (PENG) block.

The objective of the current trial is primarily to assess the analgesic efficacy of ultrasound-guided trans-muscular QLB versus ultrasound-guided PENG block in pediatric patients undergoing open hip surgery for developmental dysplasia of the hip (DDH)

Read the detailed description

During the pre-anesthesia check-up visit, the proposed intervention will be discussed with the eligible participant's parents or caregivers including data about the aim, the advantages, and the expected side effects, and then detailed informed consent will be obtained before recruitment and randomization.

All participants will be premedicated with 0.5mg/kg oral midazolam about 30min before being admitted to the operating room. The routine standard monitoring including electrocardiography (ECG), non-invasive blood pressure (NIBP, oxygen saturation (SpO2), temperature probe, and end-tidal CO2 (EtCO2) will be applied to all participants. Induction of anesthesia will be performed using a face mask with sevoflurane inhalation in oxygen starting with 2% up to 8% till complete loss of consciousness after that peripheral intravenous (IV) line will be secured where fentanyl 1 μg/kg and followed by cisatracurium 0.15mg/kg to facilitate orotracheal intubation. Anesthesia will be maintained by using isoflurane 1.2-1.5% in oxygen air mixture 50%:50% in addition to incremental cisatracurium 0.03mg/kg.

After induction of general anesthesia, the eligible participants will be randomly assigned to one of two equal groups using an allocation sequence which will be generated using permuted block randomization technique and the block size will be variable.

In both interventional groups of participants, the assigned block will be performed after induction of general anesthesia by the same investigator who will have no further role in the study. Surgery will be started about 15 minutes after performing the block.

Fentanyl 1μg/ kg will be administrated in the case of inadequate analgesia which is defined as an increase of heart rate (HR) and/or mean arterial blood pressure (MAP) more than 20% above the pre-operative values. At the end of the surgery, isoflurane will be switched off and extubation will be done after reversal of muscle relaxant with neostigmine 0.05 mg/kg and atropine 0.02 mg/kg where the participants will be transferred to the Post-Anesthesia Care Unit (PACU). Paracetamol (15 mg/kg) will be administered IV every 6 hours in all patients. Postoperative pain will be assessed by FLACC score (Face, leg, activity, cry, consolability). Morphine 0.1 mg /kg IV will be given as rescue analgesia if the FLACC score will be > 3. Postoperative HR and MAP will be recorded postoperatively at 2 h, 4, 8, 12, 24, and 48 hours.

Being tested
TQL block, PENG block
Keywords
quadratus lumborum block, pericapsular nerve group block, developmental dysplasia of the hip, postoperative analgesia, pediatric, hip surgery
Medical subject headings
Pain, Postoperative, Hip Dislocation, Developmental Dysplasia of the Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQL blockProcedure or surgery

    Also called transmuscular quadratus lumborum block

    Ultrasonography-guided quadratus lumborum block (QLB) where we will infiltrate local anesthetic solution adjacent to the anterolateral aspect of the quadratus lumborum muscle

  • PENG blockProcedure or surgery

    Also called pericapsular nerve group block

    Ultrasound-guided local anesthetic infiltration will be injected in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly

Study groups in NCT05349656
Study groupRoleWhat they receive
trans muscular quadratus lumborum (TQL) blockExperimentalafter induction of general anesthesia (GA), the participant will be placed in the lateral position, and a high-frequency linear ultrasound probe (5-13 MHz) will be 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 quadratus lumborum (QL) appears beneath the LD (anteriorly), and going farther dorsally, the QL, erector spinae, and psoas major (PM) muscles around the transverse process of lumbar vertebra L4 are seen. A 22-gauge needle 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, then 0.5 ml/kg of 0.25% bupivacaine will be injected.
Receives: Procedure: TQL block
Pericapsular nerve group (PENG) blockExperimentalAfter induction of GA, the participant will be in the supine position. A linear high-frequency ultrasound probe (5-13MHz) will be initially placed in a transverse plane over the anterior inferior iliac spine (AIIS) and then aligned with the pubic ramus by rotating the probe counterclockwise 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.
Receives: Procedure: PENG block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the time until the first rescue analgesic requirement postoperatively

    Postoperative pain will be assessed by Face, leg, activity, cry, consolability (FLACC) score at different time points with a minimum score of zero (relaxed \& comfortable) to a maximum of 10 (severe discomfort \& pain). This will be done by the attending physician either in the PACU or in the ward. If FLACC will come > 3, morphine 0.1 mg/kg will be given as rescue analgesia

    Measured: During the first postoperative 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2022
  2. Study start6 May 2022
  3. Primary completion25 Jul 2023
  4. Study completion25 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05349656
Sponsor's protocol ID
IRB NO: 00012098 SN: 0305475
Acronym
TQL
Status last verified
May 2022
First submitted
1 Apr 2022
Last updated
2 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27033707
  • Andreae MH, Andreae DA. Regional anaesthesia to prevent chronic pain after surgery: a Cochrane systematic review and meta-analysis. Br J Anaesth. 2013 Nov;111(5):711-20. doi: 10.1093/bja/aet213. Epub 2013 Jun 28.

    PubMed 23811426
  • Kao SC, Lin CS. Caudal Epidural Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:9217145. doi: 10.1155/2017/9217145. Epub 2017 Feb 26.

    PubMed 28337460
  • Auroy Y, Benhamou D, Bargues L, Ecoffey C, Falissard B, Mercier FJ, Bouaziz H, Samii K. Major complications of regional anesthesia in France: The SOS Regional Anesthesia Hotline Service. Anesthesiology. 2002 Nov;97(5):1274-80. doi: 10.1097/00000542-200211000-00034.

    PubMed 12411815
  • Huang C, Zhang X, Dong C, Lian C, Li J, Yu L. Postoperative analgesic effects of the quadratus lumborum block III and transversalis fascia plane block in paediatric patients with developmental dysplasia of the hip undergoing open reduction surgeries: a double-blinded randomised controlled trial. BMJ Open. 2021 Feb 4;11(2):e038992. doi: 10.1136/bmjopen-2020-038992.

    PubMed 33542037
  • Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.

    PubMed 27755488
  • Aksu C, Cesur S, Kus A. Pericapsular nerve group (PENG) block for postoperative analgesia after open reduction of pediatric congenital dysplasia of the hip. J Clin Anesth. 2020 May;61:109675. doi: 10.1016/j.jclinane.2019.109675. Epub 2019 Dec 1. No abstract available.

    PubMed 31796372
  • 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.

    PubMed 31022606
  • 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.

    PubMed 30063657
  • Sauter AR. The "Shamrock Method"-a new and promising technique for ultrasound guided lumbar plexus blocks. BJA: British Journal of Anaesthesia. 2013; 111(eLetters Supplement).

  • Sato M, Hara M, Uchida O. An antero-lateral approach to ultrasound-guided lumbar plexus block in supine position combined with quadratus lumborum block using single-needle insertion for pediatric hip surgery. Paediatr Anaesth. 2017 Oct;27(10):1064-1065. doi: 10.1111/pan.13208. No abstract available.

    PubMed 28888083
  • Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.

    PubMed 9220806
  • Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.

    PubMed 24049221
  • Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

    PubMed 17695343

Questions about this trial

What is this clinical trial studying?

A study testing TQL block and PENG block in people with Pain, Postoperative and Developmental Dislocation of Hip, run by Alexandria University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the time until the first rescue analgesic requirement postoperatively (time frame: During the first postoperative 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05349656, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.

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