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Quadratus Lumborum Block for Congenital Hip Dislocation Surgery

Primary Purpose

Congenital Hip Dislocation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacaine
Standard pain
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Hip Dislocation

Eligibility Criteria

1 Year - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ataturk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

ultrasound guided quadratus lumborum block

No intervention

Arm Description

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

Standard Pain Followup and Monitorization

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Need for rescue analgesic
Number of patients who required rescue analgesia in postoperative care unit in the first 2 hour
Need for analgesic
Number of patients who required analgesic in the first 24 hour

Full Information

First Posted
December 25, 2019
Last Updated
December 25, 2019
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT04212832
Brief Title
Quadratus Lumborum Block for Congenital Hip Dislocation Surgery
Official Title
Transmuscular Quadratus Lumborum Block Block for Congenital Hip Dislocation Surgery: Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
December 15, 2018 (Actual)
Study Completion Date
April 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Hip Dislocation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ultrasound guided quadratus lumborum block
Arm Type
Active Comparator
Arm Description
ultrasound guided quadratus lumborum block with 0.5 ml/kg % 0.25 bupivacaine
Arm Title
No intervention
Arm Type
Other
Arm Description
Standard Pain Followup and Monitorization
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
0.5 ml/kg %0.25 bupivacaine
Intervention Type
Other
Intervention Name(s)
Standard pain
Intervention Description
Standard pain follow up and monitorization
Primary Outcome Measure Information:
Title
Face, Legs, Activity, Cry and Consolability Score (FLACC)
Description
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.
Time Frame
Postoperative first 24hour
Secondary Outcome Measure Information:
Title
Need for rescue analgesic
Description
Number of patients who required rescue analgesia in postoperative care unit in the first 2 hour
Time Frame
2 hour
Title
Need for analgesic
Description
Number of patients who required analgesic in the first 24 hour
Time Frame
24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ataturk University
City
Erzurum
State/Province
Yakutiye
ZIP/Postal Code
25100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29807213
Citation
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.
Results Reference
background
PubMed Identifier
30684924
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. No abstract available.
Results Reference
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PubMed Identifier
30195631
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]. Braz J Anesthesiol. 2019 Mar-Apr;69(2):208-210. doi: 10.1016/j.bjan.2018.06.007. Epub 2018 Sep 6.
Results Reference
background
PubMed Identifier
30443064
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.
Results Reference
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Quadratus Lumborum Block for Congenital Hip Dislocation Surgery

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