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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Scoliosis
• Scoliosis; Adolescence

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