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OpenTrials
Completed

NCT Number: NCT04822935

Postoperative Pain in Adolescent Idiopathic Scoliosis Surgery

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.

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Key information

Conditions

Scoliosis; Adolescence Bone Diseases Musculoskeletal Diseases Scoliosis Spinal Curvatures Spinal Diseases

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Istanbul Medical Faculty

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vertebral Body Tethering

Procedure

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

Primary outcomes

  1. Comparison in terms of postoperative pain

    Time frame: 48 hours

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

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Evaluation of Surgical Methods in Terms of Postoperative Pain in Adolescent Idiopathic Scoliosis

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 30, 2021
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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