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NCT04822935 Clinical Trial

Postoperative Pain in Adolescent Idiopathic Scoliosis Surgery

Scoliosis; Adolescence Clinical Trial

Official title:
Evaluation of Surgical Methods in Terms of Postoperative Pain in Adolescent Idiopathic Scoliosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04822935
Other study ID # 2020/1561
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 30, 2021
Est. completion date November 17, 2021

Study information
Verified date November 2021
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date November 17, 2021
Est. primary completion date November 7, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Vertebral Body Tethering
VBT surgery is a surgery performed by thoracotomy in adolescent idiopathic scoliosis patients.

Locations
Country Name City State
Turkey Istanbul University Istanbul Medical Faculty Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 48 hours
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