Clinical trials: Lumbar Surgery
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
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
Degenerative Disc Disease
Study of an Expandable Interbody Device for the Lumbar Spine
The primary objective of this study is to evaluate the safety and efficacy of CALIBER expandable spacer for the treatment of degenerative disc disease.
- Trial name
- CALIBER (NCT02075554)
- Testing
- CALIBER
- Where
- 2 sites in United States
- Volunteers
- 58 people
- Sponsor
- Globus Medical Inc
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
Pain
Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery
Postoperative analgesia following spine surgery is difficult to manage. Current treatment modalities rely heavily on opioid analgesics with all of the inherent limitations and side effects.
- Trial name
- NCT03115151
- Testing
- Bupivacaine, Hydromorphone, Fentanyl
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- University of Texas Southwestern Medical Center
Lumbar Spinal Stenosis
Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (Mild®) in Patients With Symptomatic Lumbar Central Canal Stenosis
This is a single-center, randomized, prospective, double-blind clinical study to assess the clinical application and outcomes with MILD® devices versus epidural steroid injection in patients with symptomatic moderate to severe…
- Trial name
- NCT00995371
- Testing
- MILD® (Minimally Invasive Lumbar Decompression), Epidural Steroid Injection
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Coastal Orthopedics & Sports Medicine
Spinal Stenosis
Neurogenic Intermittent Claudication Evaluation Study
The objective of the NICE study is to provide clinical evidence proving that the Aperius™ PercLID™ System is safe and non-inferior to standalone decompressive surgery with regards to clinical outcomes in patients suffering from…
- Trial name
- NICE (NCT00905359)
- Testing
- Aperius™ PercLID™ System, Standalone Decompressive Surgery
- Where
- 19 sites in Australia, Belgium and 8 more
- Volunteers
- 163 people
- Sponsor
- Medtronic Spinal and Biologics
Lumbar Spine Surgery, Chronic Low-back Pain
Telehealth Mindfulness After Spine Surgery
The goal of this pilot clinical trial is to compare two behavioral interventions for patients who are recovering from lumbar spinal surgery for a degenerative spine condition. The study aims to answer the following questions: 1.
- Conditions
- Lumbar Spine Surgery, Chronic Low-back Pain, Postsurgical Pain
- Trial name
- NCT05698914
- Testing
- Telehealth mindfulness-based intervention (MBI), Telehealth Education
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- Vanderbilt University Medical Center
Spinal Injuries, Adhesions
DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery
To evaluate the safety and effectiveness of DuraGen Plus® Adhesion Barrier Matrix as an adhesion barrier in spinal surgery to reduce the extent of peridural fibrosis formation and radicular pain in comparison to a control group…
- Trial name
- NCT00387829
- Testing
- DuraGen Plus Adhesion Barrier Matrix
- Where
- 36 sites in United States
- Volunteers
- 347 people
- Sponsor
- Integra LifeSciences Corporation
Neuropathy; Radicular, Lumbar, Lumbosacral, Failed Back Surgery Syndrome
Efficacy of Pregabalin in Patients With Radicular Pain
The purpose of this study is to evaluate whether pregabalin is effective in reducing the pain in patients who present with radicular pain due to a herniated disc, spinal stenosis or failed back surgery syndrome.
- Conditions
- Neuropathy; Radicular, Lumbar, Lumbosacral, Failed Back Surgery Syndrome, Spinal Stenosis, Herniated Disc
- Trial name
- NCT00908375
- Testing
- Pregabalin, Sugar Pill
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Northwestern University
Lumbar Spine Degeneration
A Randomized Trial of Exparel vs Saline in Opioid Reduction of Pain Management Following Lumbar Spine Surgeries.
The purpose of this study is to establish a relationship between liposomal bupivacaine surgical site injection and postop opioid utilization.
- Trial name
- Exparel (NCT04644796)
- Testing
- saline 0.9%, Liposomal bupivacaine
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- University of Missouri-Columbia
Opioid Dependence, Chronic Pain
Perioperative Ketamine in Opioid-Tolerant Patients Undergoing Lumbar Spine Surgery
The goal of this study is to determine whether comprehensive perioperative administration of the N-methyl-D-aspartate (NMDA) receptor antagonist ketamine can increase postoperative pain tolerance and reduce opiate consumption in…
- Trial name
- NCT04220489
- Testing
- Ketamine
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Jacques E. Chelly
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
Pain, Intractable, Pain, Chronic
Comparison of DTM™ SCS Therapy Combined With Conventional Medical Management (CMM) to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Spine Surgery
The purpose of this investigational study is to document the safety, clinical effectiveness and health economic analytics of DTM™ SCS programming delivered through the Intellis™ neurostimulator in subjects with chronic…
- Trial name
- NCT06442410
- Testing
- DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system, Conventional Medical Management (CMM)
- Where
- 12 sites in Belgium, Germany and 2 more
- Volunteers
- 115 people
- Sponsor
- MedtronicNeuro
Back Pain
Spinal Cord Stimulation for Chronic and Intractable Back Pain
The purpose of this study is to evaluate the efficacy of spinal cord stimulation (SCS) using the Precision implantable neurostimulation device for chronic and intractable back pain in subjects who are not candidates for surgery…
- Trial name
- NCT00370695
- Testing
- Precision Spinal Cord Stimulation System
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
Lumbar Spinal Stenosis
MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
This is a multi-center, prospective, patient outcomes assessment of Minimally Invasive Lumbar Decompression with the Mild® devices in patients with symptomatic central canal spinal stenosis.
- Trial name
- NCT01082159
- Testing
- lumbar decompression
- Where
- 8 sites in United States
- Volunteers
- 55 people
- Sponsor
- Vertos Medical, Inc.
Surgical Sponge, Retained
Intraoperative Radiographic Detection of Retained Surgical Sponges
This prospective study will determine the efficacy of intraoperative x-ray to identify retained surgical sponges. The recommended practice for finding a retained sponge is by radiography.
- Trial name
- NCT04097678
- Testing
- Retained Surgical Sponge
- Where
- United States
- Volunteers
- 146 people
- Sponsor
- Twin Cities Spine Center
Hip Osteoarthritis
Lumbar Plexus vs Quadratus Lumborum Block in Post-operative Pain Following Total Hip Replacement
The Lumbar Plexus (LP) block is currently used as the standard-of-care regional anesthesia technique to provide postoperative pain management after primary hip replacement surgery at UPMC Shadyside Hospital.
- Trial name
- NCT03801265
- Testing
- Lumbar plexus block, Quadratus lumborum type 3 block, Ropivacaine injection
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Sharad Khetarpal
Hip Surgery, Post Operative Pain Control
Post Operative Pain Control After Pediatric Hip Surgery
Hip surgery in children is painful and the optimal modality for managing post-operative pain has not been established. This prospective randomized controlled trail compares lumbar plexus catheter (LPC), lumbar epidural catheter…
- Trial name
- NCT03435692
- Testing
- Lumbar Plexus Catheter, Lumbar Epidural Catheter, Patient Controlled Analgesia
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Seattle Children's Hospital
Spinal Stenosis, Lumbar Region, Spondylolisthesis
Evaluation of 3D Machine-vision Image Guided Surgery Spine Navigation
This study assesses clinical outcomes following the use of the MvIGS spine navigation system for treatment of spinal stenosis and degenerative spondylolisthesis of the lumbar spine in adults.
- Trial name
- NCT03968965
- Testing
- 3D MvIGS Spine Navigation, 2D Fluoroscopy
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- 7D Surgical Inc.