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Erector Spinae Plane Block for Congenital Hip Dislocation Surgery

Primary Purpose

Congenital Hip Dysplasia

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

About this trial

This is an interventional treatment trial for Congenital Hip Dysplasia focused on measuring Postoperative Analgesia, Ultrasound guided erector spinae plane block

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
  • ASA III-IV

Sites / Locations

  • Ataturk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Saline + Placebo

ultrasound guided erector spinae plane block

Arm Description

Ultrasound guided 0.5 ml/kg saline injection to erector spinae plane

Ultrasound guided 0.5 ml/kg % 0.250 bupivacaine injection to erector spinae plane

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
May 9, 2019
Last Updated
July 21, 2020
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT03949686
Brief Title
Erector Spinae Plane Block for Congenital Hip Dislocation Surgery
Official Title
Erector Spinae Plane Block for Congenital Hip Dislocation Surgery: Randomized Controlled Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 22, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
February 1, 2020 (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. The aim of this study was to evaluate the analgesic effect of ultrasound guided erector spinae plane block (ESP) 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 Dysplasia
Keywords
Postoperative Analgesia, Ultrasound guided erector spinae plane block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saline + Placebo
Arm Type
Sham Comparator
Arm Description
Ultrasound guided 0.5 ml/kg saline injection to erector spinae plane
Arm Title
ultrasound guided erector spinae plane block
Arm Type
Active Comparator
Arm Description
Ultrasound guided 0.5 ml/kg % 0.250 bupivacaine injection to erector spinae plane
Intervention Type
Drug
Intervention Name(s)
Saline Solution
Other Intervention Name(s)
saline
Intervention Description
0.5 ml/kg saline
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
0.5 ml/kg %0.25 bupivacaine
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 ASA III-IV
Facility Information:
Facility Name
Ataturk University
City
Erzurum
ZIP/Postal Code
25100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30139214
Citation
Elkoundi A, Bentalha A, Kettani SEE, Mosadik A, Koraichi AE. Erector spinae plane block for pediatric hip surgery -a case report. Korean J Anesthesiol. 2019 Feb;72(1):68-71. doi: 10.4097/kja.d.18.00149. Epub 2018 Aug 24.
Results Reference
background
PubMed Identifier
30662115
Citation
Tulgar S, Kose HC, Selvi O, Senturk O, Thomas DT, Ermis MN, Ozer Z. Comparison of Ultrasound-Guided Lumbar Erector Spinae Plane Block and Transmuscular Quadratus Lumborum Block for Postoperative Analgesia in Hip and Proximal Femur Surgery: A Prospective Randomized Feasibility Study. Anesth Essays Res. 2018 Oct-Dec;12(4):825-831. doi: 10.4103/aer.AER_142_18.
Results Reference
background

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Erector Spinae Plane Block for Congenital Hip Dislocation Surgery

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