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Postoperative Pain in Adolescent Idiopathic Scoliosis Surgery

Primary Purpose

Scoliosis; Adolescence

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Vertebral Body Tethering
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis; Adolescence

Eligibility Criteria

9 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ASA score 1-3 patients
  • Adolescent idiopathic scoliosis patients
  • Patients who accepted to be included in the study and received written parental consent

Exclusion Criteria:

  • Patients with vertebral anomaly due to a secondary reason
  • Patients with a diagnosed syndrome
  • Patients with a Cobb angle below 40.
  • Patients who undergoing reoperation

Sites / Locations

  • Istanbul University Istanbul Medical Faculty

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Posterior Spinal Instrumentation

Vertebral Body Tethering

Arm Description

Outcomes

Primary Outcome Measures

Comparison in terms of postoperative pain
Opioid consumption and VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable) for measurement of postoperative pain

Secondary Outcome Measures

Full Information

First Posted
January 30, 2021
Last Updated
November 18, 2021
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04822935
Brief Title
Postoperative Pain in Adolescent Idiopathic Scoliosis Surgery
Official Title
Evaluation of Surgical Methods in Terms of Postoperative Pain in Adolescent Idiopathic Scoliosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
November 7, 2021 (Actual)
Study Completion Date
November 17, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Scoliosis is a 3-dimensional, structural deformity of the spine. Idiopathic scoliosis is the most common type and it constitutes 75-80% of all scoliosis. Surgical methods are the most effective way to correct the deformity in patients who cannot achieve adequate improvement with supportive therapy. Adolescent idiopathic scoliosis surgeries are among the most invasive surgeries performed on children and adolescents. Large surgical incision and massive tissue damage cause severe postoperative pain. In this study, we aim to compare posterior instrumentation (PE) and vertebral body tethering (VBT) surgeries performed in adolescent idiopathic scoliosis patients in terms of anesthetic management and postoperative pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis; Adolescence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Posterior Spinal Instrumentation
Arm Type
No Intervention
Arm Title
Vertebral Body Tethering
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Vertebral Body Tethering
Intervention Description
VBT surgery is a surgery performed by thoracotomy in adolescent idiopathic scoliosis patients.
Primary Outcome Measure Information:
Title
Comparison in terms of postoperative pain
Description
Opioid consumption and VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable) for measurement of postoperative pain
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA score 1-3 patients Adolescent idiopathic scoliosis patients Patients who accepted to be included in the study and received written parental consent Exclusion Criteria: Patients with vertebral anomaly due to a secondary reason Patients with a diagnosed syndrome Patients with a Cobb angle below 40. Patients who undergoing reoperation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irem Basaran, MD
Organizational Affiliation
Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University Istanbul Medical Faculty
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
35793183
Citation
Canbolat N, Basaran I, Altun D, Akgul T, Buget MI. Postoperative Pain in Adolescent Idiopathic Scoliosis Surgery: A Randomized Controlled Trial. Pain Physician. 2022 Jul;25(4):E589-E596.
Results Reference
derived

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Postoperative Pain in Adolescent Idiopathic Scoliosis Surgery

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