Scoliosis Clinical Trial
Official title:
The Influence of Pharmacogenetics on Methadone Dose, Safety, and Outcomes After Spine Fusion
The overall objective is to develop a patient oriented research program to efficiently evaluate the effects of pharmacogenetic variants on the dose-response relationships and safety of opioids and non-opioid analgesics. If an opioid regimen can be created that produces excellent opioid analgesia with minimal toxicity related to supratherapeutic opioid concentrations (i.e., ventilatory depression), other non-opioid analgesics (i.e., gabapentin/pregabalin, ketamine, lidocaine, cyclooxygenase inhibitors, etc.) that may decrease preoperative opioid requirements can be more efficiently and safely evaluated. These interventions may limit the opioid related toxicities related to effect site concentrations that are below those required when opioids are the predominant analgesic, such as opioid related ileus. Methadone's slow elimination clearance and limited pharmacokinetic drug-drug interactions make it an attractive perioperative opioid. The first step towards personalized opioid analgesia is to determine the effect of common pharmacogenetic variants that affect either methadone metabolism (CYP2B6) or opioid elimination.
This study is being done to find the optimal dose of methadone (a long acting pain medication) that decreases the amount of pain that people have after spine surgery. Five different doses of methadone will be compared to each other, while keeping the remainder of the anesthetic routine for surgery. The investigators will determine the analgesic dose-response of methadone. The investigators will also determine the effect of methadone on the incidence of opioid related side effects, the quality of outcome of recovery, and the change in the 3-month opioid use. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04848376 -
Post-Market Clinical Follow-up Study of A-SPINE's Products
|
||
| Recruiting |
NCT05944393 -
Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery
|
N/A | |
| Recruiting |
NCT05888038 -
Virtual Reality's Effect on Decreasing Pain and Subsequent Opioid Use in Pediatric Patients in the Post-Operative Period Following Scoliosis Repair
|
N/A | |
| Completed |
NCT02890654 -
Scoliosis and Quality of Life of Adolescents
|
||
| Completed |
NCT02413788 -
Impact of Aerobic Training and Combined in Inflammatory Markers in Patients With Adolescent Idiopathic Scoliosis
|
N/A | |
| Completed |
NCT02558985 -
Pulmonary Compliance Changes During Manipulation of Early Onset Scoliosis and Cast Application
|
||
| Completed |
NCT02531945 -
Evaluation of the Surface Topography for Monitoring Scoliosis Patients Aged 10-13 Years
|
N/A | |
| Terminated |
NCT02134704 -
MOUVSCO: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis
|
N/A | |
| Completed |
NCT02609009 -
Back Pain and Spinal Manipulation in Adolescent Scoliosis
|
N/A | |
| Completed |
NCT02285621 -
Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis
|
N/A | |
| Withdrawn |
NCT00768313 -
Phase IV Comparing Rods of Yield Strengths to Correct Adolescent Idiopathic Scoliosis.
|
Phase 4 | |
| Completed |
NCT00155545 -
Influence of Leg Length Discrepancy on the Spinal Shape and Biomechanics in Functional and Idiopathic Scoliosis Patients
|
Phase 1 | |
| Completed |
NCT00154505 -
Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons
|
Phase 1 | |
| Completed |
NCT00320619 -
Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery
|
N/A | |
| Completed |
NCT00273598 -
Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis
|
Phase 2 | |
| Completed |
NCT03135665 -
Using Radiation-free Ultrasound for Screening Scoliosis Among School Children in Hong Kong to Reduce Unnecessary X-ray Exposure
|
N/A | |
| Recruiting |
NCT04423146 -
Anesthesiologic Management Effect on Perioperative Outcome in Scoliosis Surgery
|
||
| Completed |
NCT03814239 -
Blood and Fluid Management During Scoliosis Surgery
|
||
| Withdrawn |
NCT02058238 -
ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity
|
||
| Completed |
NCT02904421 -
6 Years Study on Changes in Bone Quality, Bone Turnover and Curve Severity in AIS With and Without Calcium and Vit-D Supplementation
|