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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04212832
Other study ID # AUTFANESTHESIAHIPQLB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2018
Est. completion date April 15, 2019

Study information

Verified date December 2019
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date April 15, 2019
Est. primary completion date December 15, 2018
Accepts healthy volunteers No
Gender All
Age group 1 Year to 5 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- 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

Study Design


Intervention

Drug:
Bupivacaine
0.5 ml/kg %0.25 bupivacaine
Other:
Standard pain
Standard pain follow up and monitorization

Locations

Country Name City State
Turkey Ataturk University Erzurum Yakutiye

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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]. Rev Bras Anestesiol. 2019 Mar - Apr;69(2):208-210. doi: 10.1016/j.bjan.2018.06.007. Epub 2018 Sep 6. Portuguese. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Need for rescue analgesic Number of patients who required rescue analgesia in postoperative care unit in the first 2 hour 2 hour
Secondary Need for analgesic Number of patients who required analgesic in the first 24 hour 24 hour
See also
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Recruiting NCT04117685 - Global Hip Dysplasia Registry
Completed NCT02900482 - Research for Genetic Factors Involved in Congenital Dislocation of Hip: Genome-wide Association Study in Grand West France