208 Clinical Trials for Various Conditions
To determine if a pre-operative ketamine infusion would provide a similar decrease in post-operative analgesic and opioid consumption as intra-operative ketamine, but expand the monitoring period through the post-operative phase up to 90 days. Hypothesis is that pre-operative ketamine infusion will lead to a decrease in narcotic consumption from baseline following an elective cervical or lumbar fusion, leading to increased functionality and quality of life for these patients.
Revision Spine Surgery, Fusion of Spine, Cervical Fusion, Lumbar Fusion
The purpose of this research is to compare two outpatient pain management strategies in patients undergoing spinal surgeries such as microdiscectomies, foraminotomies, and spinal decompressions.
Spinal Disorder
Spinal surgeries are generally associated with intense pain in the postoperative period, especially for the initial few days. The aim of this study is to examine the effect of intraoperative intravenous acetaminophen in spine surgery on postoperative analgesic requirements, pain scores, patient satisfaction, and clinical recovery. Enrolled patients are randomized to receive either intravenous acetaminophen or placebo at the time of surgical closure. It is hypothesized that patients receiving intravenous acetaminophen will have improved pain scores, require less opiate medication, and have better patient satisfaction than those receiving placebo.
Lumbar; Injury
PAULA aims to collect data on the safety, performance, and effectiveness of iFuse Bedrock Granite (GRANITE) in patients who have spinal fusion surgery with pelvic fixation/ fusion.
Spinal Fusion, Deformity of Spine
Postoperative delirium is one of the most frequent adverse events following elective non-cardiac surgery and is associated with cognitive impairment at discharge, as well as in-hospital and long-term mortality, however, despite being a well-recognized problem there is a dearth of effective interventions for prevention and management. A modifiable risk factor associated with postoperative delirium is poor postoperative pain control, and by improving the pain regimen the investigators may be able to decrease the incidence and/or severity of postoperative delirium. In this study, the investigators seek to study whether a postoperative intravenous infusion of lidocaine, known to improve pain control in other contexts, can decrease the risk of postoperative delirium and other opioid-related side effects, following major reconstructive spinal surgery.
Postoperative Delirium, Postoperative Pain, Spinal Fusion
This is a Phase 2, multicenter study in subjects undergoing an open lumbar decompression surgery.
Post-Operative Pain, Lumbar Laminectomy
The investigators are looking to recruit patients into a study demonstrating the effectiveness of a superficial nerve block involving the thoracolumbar interfascial plane (TLIP) in reducing postoperative pain in those undergoing spinal surgery
Pain, Postoperative
The Researchers are trying to evaluate whether using a blood test called thromboelastogram (TEG) to manage patients undergoing multi-level spinal fusion surgery will reduce complications after surgery compared with the standard practices.
Spinal Fusion
* To demonstrate the feasibility of integrating holographic technology as a heads-up display for navigated cranial and spinal neurosurgical procedures. This entails simply displaying the navigation screen currently used by Medtronic Stealth or Brainlab systems as a holographic image that can be positioned closer to the operative field. * To develop a systematic, efficient communication and registration process allowing holographic technology to be potentially utilized as a navigation tool in cranial and spinal neurosurgery. This entails developing software, optimizing connection parameters, and devising registration techniques incorporating line-of-sight fiducial markers to allow the holographic device to function as a navigation instrument.
Surgery
STRATAFIX Symmetric PDS Plus sutures will reduce the time required for fascial closure following spinal surgery. A pilot study will aide in the design of a larger randomized controlled trial to compare suture closure time of the STRATAFIX Symmetric PDS Plus sutures versus traditional Vicryl sutures.
Fusion of Spine
This is a randomized, prospective, double-blind , placebo-controlled trial examining the effects of intraoperative dexmedetomidine infusion on pain in patients undergoing lumbar spinal fusion surgery. One hundred ten subjects (55 in each arm) will be enrolled. Subjects, over the age of 18, undergoing lumbar spinal fusion will be considered eligible for enrollment. Subjects will receive either intraoperative dexmedetomidine or placebo of normal saline infusion. They will be followed for approximately six weeks postoperatively.
Chronic Pain
The proposed research will utilize electroacupuncture, a type of needleless acupuncture that uses electrostimulation, in a randomized, double blind study, to evaluate the incidence of post-operative nausea and vomiting (PONV) in patients undergoing spinal surgeries with the transcutaneous electrical acupoint stimulation (TEAS) compared to patients without TEAS.
PONV
Constipation is a known complication of the postoperative period after spinal surgery, where prescription pain medicines called opioids are traditionally used in high doses for the treatment of surgery-related pain. The goal of this study is to determine the effectiveness of Movantik (naloxegol)-a FDA-approved drug used to treat constipation that is caused by opioids-in preventing constipation in patients undergoing spinal fusion surgery at MGH.
Constipation
The objectives of this study are to determine whether identifying patients with baseline cognitive deficits or frailty predict postoperative delirium.
Cognitive Impairment, Frail Elderly Syndrome
Patients undergoing major spinal surgery continue to experience moderate-to-severe pain during the first 2-3 days following the operative procedure. Several factors contribute to postoperative pain in this patient population. Many patients present to surgery dependent on relatively high doses of oral opioids; this daily administration leads to tolerance to the effects of these drugs as well as hyperalgesia (exposure to opioids makes subsequent pain worse). In addition, surgical procedures on the spine are very painful. Furthermore, most of the opioids used after surgery only produce analgesia (pain relief) for 2-4 hours, which leads to fluctuations in levels of pain control (patients have to push a button to deliver pain medication when they begin to feel discomfort). Recent data suggest that the use of a long-acting opioid like methadone in the operating room, which provides analgesia for 24-36 hours, may improve pain control after spinal fusion surgery. However, other pain treatment modalities are required in this patient population. Studies have demonstrated that ketamine, a drug that prevents pain by a mechanism different from opioids, is effective in reducing pain medication requirements when given in the perioperative period. Small-dose infusions not only provide analgesia, but also prevent opioid tolerance and hyperalgesia. In particular, the combination of methadone and ketamine may be especially effective in controlling pain in patients following major operations. The aim of this randomized clinical trial is to examine the effect of a low-dose perioperative infusion of ketamine, when given with methadone in the operating room, on postoperative pain medication requirements, pain scores, and clinical recovery characteristics after spinal fusion surgery.
Pain
The purpose of this study is to evaluate the effect of pharmacogenetic (PGx) guided treatment when implemented into the pre-operative process for patients undergoing an elective spinal surgical procedure and requiring post-operative acute pain management, as compared to a group of subjects with the same attributes without the guidance of PGx testing for their post-surgery pain management. This study will also evaluate whether PGx testing can reduce narcotic consumption, opioid-related adverse effects, time to mobilization, medical visits and costs.
Acute Pain, Surgery
This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in neurosurgery patients.
Deformity of Spine
The specific aim of this prospective, randomized controlled trial is to compare the effect of chewing gum on the return of bowel function in a group of patients undergoing spinal surgery with a group of matched controls that do not receive any chewing gum. A 24-hour reduction in time to passage of first flatus will be considered an important clinical difference. The research questions are: 1. Does providing chewing gum post-operatively hasten the return of bowel function? 2. Does providing chewing gum post-operatively reduced overall length of stay? 3. Does providing chewing gum post-operatively have any associated complications? 4. Does providing chewing gum post-operatively result in higher objective outcomes scores? The secondary aims are: 1. To compare hospital length of stay between the groups with a mean of ½ day considered clinically important. 2. To compare time until tolerating regular diet as defined as two consecutive meals with no complications with 24 hours considered statistically significant. 3. To compare incidence and nature of complications between the two groups. 4. To compare the time until completion of rehab milestones with 1 day being considered clinically important. 5. To compare the requirement for nutrition evaluations 6. To compare SF-12 scores as a marker of patient satisfaction with a difference of 10 points or more measured between the two groups upon discharge from hospital and at six-weeks after surgery.
Return of Bowel Function Following Spinal Surgery
Patients undergoing major spinal surgery continue to experience moderate-to-severe pain during the first 2-3 days following the operative procedure. Pain complicates the recovery process, despite the routine practice of using potent opioid analgesics. The primary reason that pain is poorly controlled in patients undergoing major surgery is that most commonly-used opioids only produce analgesia for 2-4 hours. The intermittent use of these drugs results in periods of time when a patient will experience discomfort (at which time a nurse administers more drug or the button on a patient-controlled analgesic (PCA) system is pressed to deliver more medication). The use of a long-acting opioid may be advantageous in the perioperative setting. Methadone is an opioid that has a median duration of analgesia of 24-36 hours. Therefore, a single dose administered in the operating room may reduce the need for pain medication and improve pain control for the first few postoperative days. The aim of this randomized clinical trial is to examine the effect of methadone (compared to hydromorphone) on postoperative pain management in patients undergoing major spine surgery
Hydromorphone Use, Acute Postoperative Pain, Patient Satisfaction, Chronic Persistent Surgical Pain
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. In addition it will also significantly reduce the cost of the surgical procedure. Specific Aim 1: The goal of this study is to quantitatively assess whether topical application of tranexamic acid placed into the surgical wound during lumbar spine surgery will decrease post-operative blood loss, thus lowering the need for blood transfusions. By reducing the number of transfusions participants can avoid the well-known complications associated with them. The investigators do not plan on measuring serum tranexamic acid levels. Several meta-analyses and level I studies have shown that intravenous (IV) administration of tranexamic acid is effective in reducing postoperative blood loss and the need for transfusion.
Lumbar Spinal Stenosis, Thoracic Spinal Stenosis
To quantify potential short- and long-term benefits of robotically-guided minimally invasive spine surgery (MIS) for adult patients with lower back degeneration, in comparison a matching group of control patients operated in a minimally invasive approach whether freehand or with image guidance or navigation techniques.
Degenerative Spine Disease, Spondylolisthesis, Spondylosis
This study is being done to compare people who had a standard of care spinal fusion using part of their local bone graft (a small amount of bone from the region of the spine where the fusion is occurring) to correct an adult spinal deformity and people who will have a standard of care spinal fusion using a mixture of Actifuse ABX® (a market approved bone graft substitute) and a local bone graft (a small amount of bone from the region of the spine where the fusion is occurring). This study will compare the outcomes of both groups to help the Orthopaedic surgeon conducting spinal fusions in the future. Investigators expect that Actifuse ABX® will be as good if not better than just a local bone graft.
Scoliosis, Kyphosis, Lordosis
Corrective surgery for scoliosis can result in prolonged operating room time and significant blood loss. The investigators goal is to determine what the transfusion requirements are for young adults undergoing spinal surgery for scoliosis and what other intra-operative factors influence the amount of blood and blood products used. The investigators will used the information obtained to improve the management of patients undergoing corrective surgery for scoliosis.
Scoliosis
Clinician directed use of bone morphogenetic proteins (BMPs) in ways other than FDA approved, has increased recently due to the morbidity associated with harvest of iliac crest bone graft in spinal arthrodesis procedures. FDA approved for the use in anterior lumbar fusions with LT Cage, other clinical applications of these proteins is becoming widely adopted due to their effectiveness in forming bone and facilitating fusion. Clinicians have realized while these proteins are potent stimulators of bone formation there have been anecdotal reports of increased rates of radicular pain in the postoperative period when used in interbody arthrodesis procedures. Speculation as to the mechanism of this radiculitis is postulated to be due to the inflammatory effects of these proteins. Excess bone overgrowth around the spinal nerves in proximity to the fusion cage has been reported. No prospective studies have been performed assessing the incidence and etiology of this complication. The investigators propose a prospective study evaluating the incidence of this complication as well as postoperative imaging studies to help determine whether bony overgrowth is indeed occurring adjacent to the effected spinal nerves.
Lumbar Degenerative Disease
Total intravenous anesthesia(TIVA) is a commonly used anesthetic technique. Although TIVA can be accomplished with a variety of drug combinations, infusions of Propofol and Remifentanil are often used with dosage adjusted manually by the anesthesia provider.The pharmacokinetics of these drugs are well understood, and that knowledge has led to the development of computer controlled infusion pumps that can administer the drugs based upon pharmacokinetic models. Computer controlled infusion schemes automatically adjust the drug administration based upon pharmacokinetic models which typically dictate a tapering infusion scheme. When one considers the dosage of a computer controlled infusion it is obvious that manually imitating a similar scheme may be difficult.This study will evaluate manually controlled infusion schemes using the models built into the Applied Medical Visualizations (Medvis) display and compare the manual dosage schemes to the predicted effect site concentrations and pharmacodynamic effect.
Spinal Fusion
1. To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain watertight dural closure intraoperatively in patients undergoing spinal surgery. 2. To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain watertight dural closure in patients undergoing spinal surgery up to 90 days post-procedure.
Spine Surgery, Excessive Repair, Spinal Cord Injuries, Complication of Surgical Procedure
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 receiving standard care.
Spinal Injuries, Adhesions
Postoperative visual loss resulting from surgical procedures not performed on the eye is a devastating outcome for the patient and poorly understood by the medical community. It is potentially a preventable complication. Diminished blood supply to the optic nerve, affecting both the anterior or posterior portions of the optic nerve, is the most common cause of postoperative visual loss. Other, less common causes include occlusion of the retinal artery and vein, a retinal embolism and cortical blindness. The incidence of postoperative visual loss increases in patients undergoing cardiopulmonary bypass and prone spinal surgery. Although the etiology of postoperative visual loss is unknown, it is thought to be multifactorial, and several potential risk factors have been identified, including degree of low blood pressure, preoperative hematocrit, external compression of the eye, amount of blood loss, prolonged duration of surgical time and lying in the face down position. The investigators believe this study is a unique opportunity to examine the mechanisms responsible for the antecedents to postoperative visual loss (POVL) and ischemic optic neuropathy (ION), a devastating complication of (usually) an elective surgical procedure. The purpose of this research is to try and determine the potential variables responsible for postoperative visual loss which will assist the medical community in devising methods for its prevention.
Spine Surgery, Vision Impairment
Radiostereometric Analysis (RSA) is a new imaging technique used to measure motions in the spine. It provides more accurate measurements that could help in diagnosing problems in the spine earlier than standard xray techniques.
Spinal Fusion, Lumbar Discectomy
This trial is conducted in the United States of America (USA). The purpose of this clinical research trial is to understand how safe and effective Recombinant Activated FVII is for reducing bleeding and blood transfusions in patients undergoing spinal fusion surgery.
Acquired Bleeding Disorder, Spinal Fusion