Clinical trials: Spine Surgery
Opioid Use, Pain, Postoperative
Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery
Enhanced recovery pathways (ERPs) emphasize evidence-based, multimodal anesthetic and analgesic choices to minimize opioid consumption while providing adequate pain control after surgery.
- Trial name
- ESPB-Spine (NCT04156581)
- Testing
- Bupivacaine, Dexamethasone, Saline
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Hospital for Special Surgery, New York
Digital Block
Comparison of Three Methods of Hemoglobin Monitoring
This study will further investigate the Masimo SpHb [FDA Approved] continuous non-invasive hemoglobin monitor in spine surgery patients.
- Trial name
- NCT01284296
- Testing
- Lidocaine digital block, Masimo SpHb continuous hemoglobin monitor
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, San Francisco
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
Surgery
A Pilot Trial to Determine the Effective N-acetylcysteine Dose for Opioid Reduction for Spine Surgery.
Determine the optimal dose of IV N-acetylcysteine (NAC) to produce opioid reduction following spine surgery and estimate the difference in opioid consumption between placebo and the selected optimal dose.
- Trial name
- NCT04562597
- Testing
- Dose Response Curve N-acetylcysteine 50 mg/kg, Dose Response Curve N-acetylcysteine 100 mg/kg, Dose Response Curve N-acetylcysteine 150 mg/kg
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
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
Hereditary Breast and Ovarian Cancer Syndrome, Osteoporosis
Zoledronate or Observation in Maintaining Bone Mineral Density in Patients Who Are Undergoing Surgery to Remove Both Ovaries
This randomized phase II trial is studying zoledronate to see how well it works compared to observation in maintaining bone mineral density in patients who are undergoing surgery to remove both ovaries.
- Conditions
- Hereditary Breast and Ovarian Cancer Syndrome, Osteoporosis, Ovarian Carcinoma
- Trial name
- NCT00305695
- Testing
- Laboratory Biomarker Analysis, Zoledronic Acid
- Where
- 95 sites in United States
- Volunteers
- 160 people
- Sponsor
- Gynecologic Oncology Group
Spine Diseases
Awakening in Spine Surgery: A Comparison Between Clinical Signs and Bispectral Index
BIS is one of several equipments used to monitor depth of anesthesia.Some studies found BIS can reduce total propofol dose when being used with target controlled infusion (TCI).The objective is to compare awakening time after…
- Trial name
- NCT02174913
- Testing
- bispectral index, Target controlled infusion of propofol, Fentanyl
- Where
- Thailand
- Volunteers
- 34 people
- Sponsor
- Mahidol University
Low Back Disorder
MMG vs. EMG for Cortical Breach Detection
The purpose of this study is to determine how well mechanomyography (MMG) and electromyography (EMG) prevent cortical bone breaches, or the pinching of a nerve from screw placement, in patients having lower back surgery requiring…
- Trial name
- NCT05352048
- Testing
- Triggered Electromyography, Mechanomyography
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Francis Farhadi
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
Surgical Site Infections, Post Operative Complication
2% Chlorhexidine Gluconate Skin Cloths to Prevent SSI in Spine Surgery Patients
Surgical site infection (SSI) following spinal surgery is a frequent complication and results in higher morbidity, mortality and healthcare costs.
- Trial name
- DeSSI (NCT02490631)
- Testing
- 2% chlorhexidine gluconate cloths
- Where
- United States
- Volunteers
- 158 people
- Sponsor
- Vanderbilt University
Anesthesia, Airway
Comparison of 3 Direct Laryngoscopes for Tracheal Intubation in Patients Undergoing Lumbar Spine Surgery
Hypothesis The use of Macintosh blade sized #3.5 (vs Macintosh size #3) would reduce the time required to achieve successful tracheal intubation and improve the glottic view.
- Trial name
- NCT02955511
- Testing
- Blade MAC size 3, Blade MAC size 3.5, Inscope Blade size 3.5
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Cedars-Sinai Medical Center
Scoliosis
Value of 3D Modeling in Spine Surgery
Adults (18 years and over) and children (10-17 years of age) scheduled for surgery to correct scoliosis will be included in this study, for which participation will last 6 months.
- Trial name
- NCT02771899
- Testing
- spineEOS software, EOS
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Columbia University
Lumbar Radiculopathy
Erector Spinae Block for Spine Surgery
This study is to determine whether or not the addition of liposomal bupivacaine in an ESP block will have long term benefits for patients undergoing lumbar spinal fusion surgery.
- Trial name
- NCT05417113
- Testing
- Liposomal bupivacaine, Bupivacaine
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Low Back Pain
TissueLink Study During Multi-Level Spine Surgery
The overall objective of the investigators research is to test the clinical efficacy of the TissueLink™ (Salient Surgical Technologies, Inc.) coagulation system in minimizing hemoglobin loss intraoperatively.
- Trial name
- NCT01300559
- Testing
- Tissuelink device
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Duke University
Pain
Pain Relief at Iliac Crest Bone Harvest Sites in Spine Surgery Using Bupivacaine
The use of iliac crest bone graft (ICBG) remains the gold-standard in spinal reconstructive surgery for achieving fusion. Major complications from the harvesting of ICBG are rare, but chronic pain has been reported in 10-39%.
- Trial name
- NCT01087931
- Testing
- Bupivacaine, Normal Saline
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Vanderbilt University
Infection, Spinal Injuries
The Value of Home Chlorhexidine Pre-Surgical Wash Before Spine Surgery
The study team hypothesizes that at-home cleansing of the surgical site with chlorhexidine wipes provide no added benefit to decreasing microbial activity or preventing surgical site infections.
- Trial name
- NCT02767427
- Testing
- Chlorhexidine Wipes, No intervention
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Columbia University
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.
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
Pain, Opioid Use
Comparison of Quadratus Lumborum Block Types
This study will compare the quality of analgesia and reduction of opioid use, between standard of care and two groups of local anesthetic blocks in different location in the quadratus lumborum plane, for postoperative pain…
- Conditions
- Pain, Opioid Use, Lumbar Disc Herniation
- Trial name
- NCT04588389
- Testing
- Ropivacaine injection Location 1, Ropivacaine injection Location 2, Multimodal Pharmacological Management
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Massachusetts, Worcester
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