Quadratus Lumborum Block for Congenital Hip Dislocation Surgery

NCT04212832 | Completed

• 1 other identifier: AUTFANESTHESIAHIPQLB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Developmental dysplasia of the hip (DDH) is one of the major disorder of the pediatric population with an incidence of 3 to 5 per 1000 children. Open surgical reduction of congenital hip dislocation (CHD) is typically performed after an ineffective closed reduction or older than 18 months. Multiple femoral or pelvic osteotomies and tenotomies are performed during this surgical treatment and cause severe postoperative pain.Since initial description for abdominal surgery, the quadratus lumborum block has experienced several surgeries for postoperative pain management in adults and pediatrics. One of these indication is the hip surgery and described for adult hip arthroplasty. In addition we reported two pediatric cases that single dose transmuscular quadratus lumborum block is an affective analgesia for CHD surgery. The aim of this study was to evaluate the analgesic effect of ultrasound guided transmuscular quadratus lumborum block in pediatric patients undergoing CHD surgery.

Conditions

Congenital Hip Dislocation

Outcome Measures

Primary Outcomes (1)

• Face, Legs, Activity, Cry and Consolability Score (FLACC)

  FLACC scale will be used. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.

  Postoperative first 24hour

Secondary Outcomes (2)

• Need for rescue analgesic

  2 hour

• Need for analgesic

  24 hour

Study Arms (2)

ultrasound guided quadratus lumborum block

ACTIVE COMPARATOR

ultrasound guided quadratus lumborum block with 0.5 ml/kg % 0.25 bupivacaine

Drug: Bupivacaine

No intervention

OTHER

Standard Pain Followup and Monitorization

Other: Standard pain

Interventions

Bupivacaine DRUG

0.5 ml/kg %0.25 bupivacaine

ultrasound guided quadratus lumborum block

Standard pain OTHER

Standard pain follow up and monitorization

No intervention

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- American Society of Anesthesiologist's physiologic state I-II patients undergoing hip dislocation surgery

You may not qualify if:

• chronic pain
• bleeding disorders
• renal or hepatic insufficiency
• patients on chronic non-steroidal anti-inflammatory medications
• emergency cases
• Incomplete patient forms
• infection of the skin at the site of needle puncture area
• patients with known allergies to any of the study drugs
• American Society of Anesthesiologist's III-IV

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, Yakutiye, 25100, Turkey (Türkiye)

Location

Related Publications (4)

• Ahiskalioglu A, Yayik AM, Alici HA, Ezirmik N. Ultrasound guided transmuscular quadratus lumborum block for congenital hip dislocation surgery: Report of two pediatric cases. J Clin Anesth. 2018 Sep;49:15-16. doi: 10.1016/j.jclinane.2018.05.018. Epub 2018 May 26. No abstract available.

  PMID: 29807213 BACKGROUND

• Ahiskalioglu A, Yayik AM, Alici HA. Response to Ince et al.: Ultrasound-guided quadratus lumborum plane block for congenital hip dislocation surgery: Dermatomes and osteotomes 'J Clin Anesth. 2018;54:140'. J Clin Anesth. 2019 Sep;56:39-40. doi: 10.1016/j.jclinane.2019.01.022. Epub 2019 Jan 23. No abstract available.

  PMID: 30684924 BACKGROUND

• Yayik AM, Cesur S, Ozturk F, Ahiskalioglu A, Celik EC. [Continuous quadratus lumborum type 3 block provides effective postoperative analgesia for hip surgery: case report]. Braz J Anesthesiol. 2019 Mar-Apr;69(2):208-210. doi: 10.1016/j.bjan.2018.06.007. Epub 2018 Sep 6.

  PMID: 30195631 BACKGROUND

• Tulgar S, Ermis MN, Ozer Z. Combination of lumbar erector spinae plane block and transmuscular quadratus lumborum block for surgical anaesthesia in hemiarthroplasty for femoral neck fracture. Indian J Anaesth. 2018 Oct;62(10):802-805. doi: 10.4103/ija.IJA_230_18.

  PMID: 30443064 BACKGROUND

MeSH Terms

Conditions

Hip Dislocation, Congenital

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 25, 2019
• First Posted: December 30, 2019
• Study Start: June 15, 2018
• Primary Completion: December 15, 2018
• Study Completion: April 15, 2019
• Last Updated: December 30, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)