Scoliosis; AdolescenceNCT04822935
Postoperative Pain in Adolescent Idiopathic Scoliosis Surgery
A study testing Vertebral Body Tethering in people with Scoliosis; Adolescence, run by Istanbul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis; Adolescence
- What is being tested?
- Vertebral Body Tethering
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2021to 17 Nov 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- ASA score 1-3 patients
- Adolescent idiopathic scoliosis patients
- Patients who accepted to be included in the study and received written parental consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Medical Faculty
Istanbul
About this study
Official title: Evaluation of Surgical Methods in Terms of Postoperative Pain in Adolescent Idiopathic Scoliosis
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.
- Conditions
- Scoliosis; Adolescence
- Being tested
- Vertebral Body Tethering
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertebral Body TetheringProcedure or surgery
VBT surgery is a surgery performed by thoracotomy in adolescent idiopathic scoliosis patients.
| Study group | Role | What they receive |
|---|---|---|
| Posterior Spinal Instrumentation | No intervention | Not described |
| Vertebral Body Tethering | Experimental | Not described Receives: Procedure: Vertebral Body Tethering |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start30 Jun 2021
- Primary completion7 Nov 2021
- Study completion17 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scoliosis; AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur Canbolat, Istanbul University
- Investigators
- Irem Basaran, MD, Principal investigator, Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822935
- Sponsor's protocol ID
- 2020/1561
- Status last verified
- Nov 2021
- First submitted
- 30 Jan 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35793183