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

Pain, Postoperative Clinical Trial

— TQL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05349656
• Other study ID #: IRB NO: 00012098 SN: 0305475
• Status: Completed
• Phase: N/A
• Start date: May 6, 2022
• Est. completion date: July 25, 2023

Study information

• Verified date: May 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 25, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

• Previous hip surgery.

• Previous analgesic medication, chronic pain.

• Previously known neurological pathologies or central nervous system disorders

Related Conditions & MeSH terms

• Developmental Dysplasia of the Hip
• Hip Dislocation
• Hip Dislocation, Congenital
• Pain, Postoperative

Intervention

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

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (14)

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 abstra — View Citation

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. — View Citation

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: 10.1097/00000542-200211 — View Citation

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.000000 — View Citation

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. — View Citation

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. — 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

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 do — View Citation

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. — View Citation

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. — 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

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. d — View Citation

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).

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	During the first postoperative 48 hours