Postoperative Pain in Adolescent Idiopathic Scoliosis Surgery

Sponsor

Istanbul University (Other)

Overall Status

Completed

CT.gov ID

NCT04822935

Collaborator

(none)

Enrollment

Location

Arms

4.6

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Scoliosis; Adolescence	Procedure: Vertebral Body Tethering	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 30, 2021

Actual Primary Completion Date :

Nov 7, 2021

Actual Study Completion Date :

Nov 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Posterior Spinal Instrumentation
Experimental: Vertebral Body Tethering	Procedure: Vertebral Body Tethering VBT surgery is a surgery performed by thoracotomy in adolescent idiopathic scoliosis patients.

Arm

Intervention/Treatment

No Intervention: Posterior Spinal Instrumentation

Experimental: Vertebral Body Tethering

Procedure: Vertebral Body Tethering

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

Outcome Measures

Primary Outcome Measures

Comparison in terms of postoperative pain [48 hours]
Opioid consumption and VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable) for measurement of postoperative pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul University Istanbul Medical Faculty	Istanbul		Turkey

Sponsors and Collaborators

Istanbul University

Investigators

Principal Investigator: Irem Basaran, MD, Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nur Canbolat, Principal Investigator, M.D., Istanbul University

ClinicalTrials.gov Identifier:

NCT04822935

Other Study ID Numbers:

2020/1561

First Posted:

Mar 30, 2021

Last Update Posted:

Nov 19, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Scoliosis

Pain, Postoperative

Study Results

No Results Posted as of Nov 19, 2021