Clinical trials: Spine Surgeries
Adolescent Idiopathic Scoliosis, Multimodal Analgesia
Propofol + Remifentanil vs. Propofol + Dexmedetomidine in Adolescent Idiopathic Scoliosis Patients Having Spine Surgery
Patients with Adolescent Idiopathic Scoliosis may need surgery to correct their scoliosis. General anesthesia is required for this surgery, and a multimodal analgesic regimen using combinations of opioid and non-opioid…
- Conditions
- Adolescent Idiopathic Scoliosis, Multimodal Analgesia, Opioid Induced Hyperalgesia, Remifentanil
- Trial name
- NCT06096181
- Testing
- Remifentanil TIVA, Dexmedetomidine TIVA, Propofol TIVA
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Cedars-Sinai Medical Center
Degenerative Disc Disease, Trauma (Including Fractures)
BIO4 Clinical Case Study: Cervical Spine
The goal of this study is to investigate the efficacy of BIO4 bone matrix in patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery.
- Conditions
- Degenerative Disc Disease, Trauma (Including Fractures), Spondylolisthesis
- Trial name
- NCT03077204
- Testing
- 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window)., Aviator Anterior Cervical Plating System
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Seton Healthcare Family
Spinal Diseases
Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions
There is a clear need in spine surgery to place pedicle screws in the right place in the spine with good accuracy to avoid damage to important structures (spinal cord, nerve roots or vertebral arteries).
- Trial name
- NCT03015142
- Testing
- New image-guidance software
- Where
- Sweden
- Volunteers
- 21 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Postoperative Pain Management
Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries
Primary Objective: The primary objective of this study is to compare postsurgical opioid consumption through 72 hours postsurgery in patients receiving local infiltration analgesia (LIA) with EXPAREL and bupivacaine HCl (EXPAREL…
- Trial name
- FUSION (NCT03927911)
- Testing
- EXPAREL and Bupivacaine, Standard of Care
- Where
- 12 sites in United States
- Volunteers
- 65 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Spine Surgery, Wounds Vac
Prophylactic Application of an Incisional Wound Vac to Prevent Wound Complications in Obese Spine Surgery Patients
This is a prospective randomized study evaluating the use of a prophylactic incision wound vac dressing, applied in the OR, on patients undergoing posterior spine surgery with a BMI>35.
- Trial name
- NCT02926924
- Testing
- Wound Vac, Standard Dressing
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- University of Michigan
Pain, Postoperative
Safety and Efficacy Study of Fentanyl Iontophoretic Transdermal System (ITS) for Management of Moderate to Severe Acute Pain in Participants Who Have Undergone Elective Spine or Orthopedic Surgery
The purpose of this study is to evaluate in daily clinical practice the safety and efficacy of fentanyl Iontophoretic Transdermal (through the skin) System (ITS) for management of moderate (medium level of seriousness) to severe…
- Trial name
- NCT00779038
- Testing
- Fentanyl ITS
- Where
- 3 sites in Belgium
- Volunteers
- 13 people
- Sponsor
- Janssen Cilag N.V./S.A.
Pain Control
A Study of Intrathecal Hydromorphone for Pediatric Idiopathic Scoliosis Repair
The purpose of this study is to identify a dose of intrathecal hydromorphone (opioid pain medicine) that optimizes pain control but minimizes side effects historically seen with this class of pain medications.
- Trial name
- NCT05552443
- Testing
- Hydromorphone 2.5 mcg/kg, Hydromorphone 2.75 mcg/kg, Hydromorphone 3 mcg/kg
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Mayo Clinic
Adult Spinal Deformity
Tranexamic Acid Dosing in Adult Spinal Deformity Surgery
The purpose of this study is to evaluate two dosing protocols for tranexamic acid (TXA), an anti-fibrinolytic used to decrease blood loss in adult patients undergoing complex, reconstructive spinal fusion surgeries.
- Trial name
- NCT02053363
- Testing
- Tranexamic Acid (Cyklokapron)
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Washington University School of Medicine
Spinal Surgery, Vascular Surgery
Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis
The purpose of this study is to evaluate the safety and immune system response to recombinant thrombin when used to control bleeding in spinal and vascular surgery.
- Trial name
- NCT00491608
- Testing
- rThrombin
- Where
- United States
- Volunteers
- 234 people
- Sponsor
- ZymoGenetics
Lumbar Degenerative Disc Disease
Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery
Adjunct therapy for increasing posterolateral fusion success following single level posterior instrumented lumbar surgery.
- Trial name
- EXO-SPINE (NCT00744861)
- Testing
- Exospine, Exogen 4000+
- Volunteers
- 328 people
- Sponsor
- Bioventus LLC
Lumbar Spinal Stenosis, Thoracic Spinal Stenosis
Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery
Hypothesis: Topical application of Tranexamic acid into the surgical wound during spine surgery will decrease the overall blood loss post-operatively. This reduction in blood loss will reduce the need for transfusion.
- Trial name
- NCT02063035
- Testing
- Tranexamic Acid
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Massachusetts General Hospital
Lumbar Spine Surgery
Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients
The purpose of the study is to help determine the appropriate dose of DepoDur for use in spinal surgery. The study will also assess the safety of this drug in this patient population.
- Trial name
- DepoDur (NCT00335517)
- Testing
- DepoDur
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- University of Rochester
Pain, Postoperative, Spine Injuries and Disorders
An Analysis of the Efficacy of a Pre-Emptive Multimodal Pain Regimen in Reducing Acute Post-Operative Pain and Narcotic Pain Medication Requirements in Spine Surgery
The aim of this study is to investigate the hypothesis that multimodal pain regimen (consisting of acetaminophen, celecoxib, gabapentin, and oxycodone) administered pre-operatively before elective spine surgery significantly…
- Conditions
- Pain, Postoperative, Spine Injuries and Disorders, Narcotic Use
- Trial name
- NCT04522206
- Testing
- Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- NYU Langone Health
Chronic Low-back Pain, Postsurgical Pain
Postoperative Telehealth Mindfulness Intervention After Spine Surgery
Lumbar spine pain is the leading cause of years lived with a disability and affects over 50 million individuals in the United States.
- Conditions
- Chronic Low-back Pain, Postsurgical Pain, Opioid Use, Lumbar Spine Surgery
- Trial name
- NCT04648683
- Testing
- Individual telehealth mindfulness, Group telehealth mindfulness
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Vanderbilt University Medical Center
Bone Diseases, Spine Cancer
Custom Pack in Spine Surgery
Recent evidence suggests the efficacy of "custom pack" procedure on the operators reduction time and on the contamination risk due to the opening of many sterile packs.
- Conditions
- Bone Diseases, Spine Cancer, Spine Osteoarthritis
- Trial name
- kit (NCT03050203)
- Testing
- custom pack, standard care
- Where
- Italy
- Volunteers
- 37 people
- Sponsor
- Istituto Ortopedico Rizzoli
Intervertebral Disc Degeneration
Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery
Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation with fentanyl demand controlled by the patient.
- Trial name
- Duloxetine (NCT02535000)
- Testing
- Duloxetine
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Serviço de Anestesiologia de Joinville
Postoperative Delirium
Comparison of Postoperative Delirium in Patients Anaesthetised With Isoflurane and Desflurane During Spinal Surgery
Postoperative delirium (POD) is a known complication of inhalational agents used to anaesthetise patients for surgery with potential long term implications.The incidence of postoperative delirium in spine surgery is 3.3% to…
- Trial name
- NCT02925611
- Testing
- Isoflurane, Desflurane
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Lumbar Spine Injury
The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery
The purpose of this study is to determine whether administration of a non-centrally acting muscle relaxants will improve the Overall Benefit of Analgesia Score (OBAS), and Richmond Agitation Sedation Scale (RASS) scores in…
- Trial name
- NCT03762109
- Testing
- Dantrolene
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- Beth Israel Deaconess Medical Center
Evoked Potentials, Visual
A Novel Method for Capturing the Visual Evoked Potential During Spine Surgery Under Total Intravenous Anesthesia
Spine surgery in the prone position (which involves lying face down) is associated with various visual changes, ranging from temporary changes in acuity (or sharpness) to permanent blindness.
- Trial name
- VEP (NCT02563028)
- Testing
- SightSaver Visual Stimulator
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Hospital for Special Surgery, New York
Spine Deformity
A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains
The examination of the ability of the OrthoPAT® blood collection device to decrease the transfusion rate and volume of adults undergoing posterior spine surgery for deformity correction of 6 levels or more.
- Trial name
- NCT02286102
- Testing
- OrthoPAT, Constavac
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Hospital for Special Surgery, New York