Clinical trials: Spinal Surgery
Pain, Postoperative
Analgesic Efficacy of Repeated Doses of Intravenous (IV) Acetaminophen in Post-operative Pediatric Spine Fusion Patients
This is a prospective, randomized, double-blinded, placebo controlled trial Potential subjects will be identified from the Pre-Surgical Anesthesia Clinic visit.
- Trial name
- IV APAP SF (NCT01394718)
- Testing
- Intravenous Acetaminophen
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- Children's Hospital of Philadelphia
Idiopathic Scoliosis
Methadone vs Magnesium in Spinal Fusion
Significant pain may occur following posterior spinal fusion despite the use of conventionally accepted techniques including patient controlled analgesia.
- Trial name
- NCT01795495
- Testing
- Methadone hydrochloride, Magnesium Sulfate, Remifentanil
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Nationwide Children's Hospital
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
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
Intracranial Aneurysm, Brain Edema
Goal-Directed Intraoperative Fluid Management Using FloTrac© Monitoring in High-Risk Neurosurgical Patients
This is a prospective, randomized controlled trial to determine if using FloTrac/EV1000 system in neurosurgical patients undergoing craniotomies for aneurysm repair or tumor resection complicated by cerebral edema, or complex…
- Conditions
- Intracranial Aneurysm, Brain Edema, Scoliosis, Surgery
- Trial name
- NCT02701582
- Testing
- Phenylephrine, Epinephrine, Albumin
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- NYU Langone Health
Scoliosis
Tranexamic Acid (TXA) Versus Epsilon Aminocaproic Acid (EACA) Versus Placebo for Spine Surgery
Tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) have been reported to reduce blood loss in the cardiac surgery literature but they have not been reported in use head-to-head in the orthopedic surgery literature.
- Trial name
- NCT00958581
- Testing
- Tranexamic Acid, Normal Saline, Epsilon aminocaproic acid
- Where
- United States
- Volunteers
- 177 people
- Sponsor
- NYU Langone Health
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
Systemic Lidocaine Improves Pain Control After Surgery by Attenuating the Systemic Inflammatory Response to Surgery
IV Lidocaine in Pediatric AIS
This study addresses the focus areas of Post-Operative Pain Management. We propose a randomized, triple-blind, placebo-controlled trial to investigate the efficacy of a systemic infusion of intravenous lidocaine as a non-opioid…
- Trial name
- PEDS LIDO (NCT03893318)
- Testing
- IV lidocaine
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Washington University School of Medicine
Pain, Postoperative, Postoperative Nausea and Vomiting
Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery
There will be two groups in this study: one group will be given the standard infusion of naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the other group will receive a higher dose.
- Conditions
- Pain, Postoperative, Postoperative Nausea and Vomiting, Scoliosis
- Trial name
- NCT01531439
- Testing
- Naloxone
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- Children's Mercy Hospital Kansas City
Pain
Methadone in Pediatric Anesthesiology II
Three arm randomized controlled trial to evaluate the efficacy of a single dose of intraoperative methadone in reducing post-operative pain and opioid consumption in adolescents undergoing posterior spinal fusion.
- Trial name
- MEPAII (NCT01990573)
- Testing
- 0.3mg/kg IV methadone HCl, 0.4mg/kg IV methadon HCl, control no methadone
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Washington University School of Medicine
Neuromuscular Diseases, Neuromuscular Scoliosis
Efficacy of Surgical Treatment by Different Pedicle Screw Systems in Pediatric Neuromuscular Spinal Deformity
This study was sponsored by Federal state budgetary institution "Russian scientific center for traumatology and orthopedics" n.a. acad. G.A. Ilizarov" of the Ministry of Health of Russian Federation.
- Trial name
- NCT03863496
- Testing
- Scoliosis surgery
- Where
- Russia
- Volunteers
- 71 people
- Sponsor
- Ilizarov Center
Idiopathic Scoliosis
Skeletal Muscle and Adipose Tissue Study
The purpose of this research study is to compare the current standard of care for prophylactic Cefazolin administered every 3 hours intravenously with continuous infusion of Cefazolin during pediatric spinal surgery.
- Trial name
- NCT03190668
- Testing
- Bolus dose of Cefazolin, Continuous Cefazolin drip, Paraspinal muscle microdialysis catheters
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of Florida
Surgical Site Infection
Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery
This study will evaluate the safety of povidone-iodine irrigation in pediatric spinal patients by collecting pre- and post-operative safety labwork.
- Trial name
- NCT02527512
- Testing
- Povidone-Iodine, Normal Saline
- Where
- 2 sites in United States
- Volunteers
- 173 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Spinal Deformity
Spinal Deformity Intraoperative Monitoring.
A multicenter, international prospectively collected patient cohort undergoing high-risk spinal cord level surgery or spinal osteotomy procedures will be enrolled to establish the incidence of intraoperative alerts in high-risk…
- Trial name
- NCT03880292
- Testing
- Document intraoperative Maneuvers
- Where
- 24 sites in United States, Australia and 12 more
- Volunteers
- 592 people
- Sponsor
- AO Foundation, AO Spine
Adolescent Idiopathic Scoliosis
MESA Rail™ AIS Study - Preservation of Curve Correction
To evaluate the restoration and maintenance of thoracic kyphosis and coronal curve correction demonstrated through the surgical implantation of the K2M MESA Rail™ Deformity System as compared to literature reported outcomes for…
- Trial name
- NCT02062606
- Testing
- MESA Rail™ Deformity System
- Volunteers
- 188 people
- Sponsor
- K2M, Inc.
Hemostasis
Safety and Efficacy of Topical Thrombin (Human) Grifols as an Adjunct to Hemostasis During Surgery
This purpose of this clinical trial was to study the safety and efficacy of Topical Thrombin (Human) Grifols as an add-on treatment to help stop bleeding during vascular, liver, soft tissue, and spinal surgical procedures.
- Trial name
- NCT02014402
- Testing
- Human thrombin, Bovine thrombin
- Where
- 20 sites in United States
- Volunteers
- 181 people
- Sponsor
- Instituto Grifols, S.A.
Juvenile; Scoliosis, Scoliosis Idiopathic
Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery
This is a randomized controlled trial to test effectiveness of the SurgeryPal intervention vs. education control to improve acute and chronic pain and health outcomes in youth undergoing major musculoskeletal surgery.
- Conditions
- Juvenile; Scoliosis, Scoliosis Idiopathic, Scoliosis; Adolescence, Scoliosis;Congenital
- Trial name
- SurgeryPal (NCT04637802)
- Testing
- CBT (SurgeryPal), Education
- Where
- United States
- Volunteers
- 433 people
- Sponsor
- Seattle Children's Hospital
Infants Undergoing Surgery
Changes in Tissue and Cerebral Oxygenation Following Spinal Anesthesia in Neonates, Infants, and Children
Investigators have started an awake spinal anesthesia program in conjunction with pediatric surgical colleagues. Patients are offered the option of awake spinal anesthesia instead of general anesthesia for appropriate surgical…
- Trial name
- NCT02840253
- Testing
- NIRS
- Volunteers
- 23 people
- Sponsor
- Joseph D. Tobias
Spinal Fusion, Cardiopulmonary Bypass
Point of Care Testing in Pediatric Patients Undergoing Major Surgery
The current study proposes to investigate Point of Care Testing (POCT) (Coagcheck®) and compare obtained results versus standard laboratory coagulation parameters prothrombin time (PT) and partial thromboplastin time (PTT).
- Trial name
- NCT01742936
- Testing
- CoaguChek, Hospital Laboratory
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Nationwide Children's Hospital