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Postoperative Pain in Adolescent Idiopathic Scoliosis Surgery

NCT ID: NCT04822935

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2021-11-17

Brief Summary

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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.

Detailed Description

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Conditions

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Scoliosis; Adolescence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Posterior Spinal Instrumentation

Group Type NO_INTERVENTION

No interventions assigned to this group

Vertebral Body Tethering

Group Type EXPERIMENTAL

Vertebral Body Tethering

Intervention Type PROCEDURE

VBT surgery is a surgery performed by thoracotomy in adolescent idiopathic scoliosis patients.

Interventions

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Vertebral Body Tethering

VBT surgery is a surgery performed by thoracotomy in adolescent idiopathic scoliosis patients.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Nur Canbolat

Principal Investigator, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Irem Basaran, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

Locations

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Istanbul University Istanbul Medical Faculty

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 35793183 (View on PubMed)

Other Identifiers

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2020/1561

Identifier Type: -

Identifier Source: org_study_id