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Showing 1-20 of 110 trials
NCT07545733
This randomized controlled clinical trial aims to compare the effects of two different positive end-expiratory pressure (PEEP) levels (5 cmH₂O and 8 cmH₂O) on respiratory mechanics in patients undergoing lumbar spine surgery in the prone position under total intravenous anesthesia (TIVA). Prone positioning may adversely affect lung compliance and gas exchange, making optimal ventilatory strategies essential. Driving pressure and mechanical power are considered key determinants of ventilator-induced lung stress. This study will evaluate the impact of different PEEP levels on respiratory parameters and intraoperative physiological changes.
NCT07319156
There is no study in the current literature that systematically investigates the extent of upper-extremity proprioceptive impairment in patients with radicular neuropathic symptoms secondary to cervical disc herniation, nor its association with clinical findings. Although existing reviews emphasize proprioceptive deficits in populations with neck pain or cervical spondylosis, no studies specifically address the subgroup of cervical disc-related radiculopathy. This gap in knowledge hinders the integration of proprioceptive assessments with upper-extremity functional outcome measures in diagnostic and rehabilitative processes, suggesting a need for more specific data to guide sensory-motor training approaches. The primary aim of the present study is to assess upper-extremity proprioception in patients with cervical radiculopathy by comparing them with a healthy control group. The secondary aim is to examine the relationship between upper-extremity proprioception and clinical outcomes, including parameters such as pain and functional status.
NCT07429708
Laminectomy is a routine procedure for patients with lumbar spinal stenosis, offering significant benefits such as reduced low back pain, alleviation of radiculopathy, and improved motor strength 1 23. Despite these advantages, postoperative pain remains a challenge for anesthesiologists. According to Davin et al., approximately 80% of patients undergoing lumbar laminectomy experience postoperative discomfort, with 20% developing persistent postsurgical pain (PPSP). The application of erector spinae plane (ESP) block in lumbar laminectomy surgery significantly reduces postoperative pain and hospital length of stay. However, ESP block without adjuvants has limitations in duration. Adjuvants are thus required to optimize the effects of ESP block 4. Dexamethasone is a glucocorticoid that is widely used in the perioperative setting. Interfascial administration of dexamethasone has been shown to prolong the duration of analgesia provided by the peripheral nerve blocks. Pehora et al (2017) reported that perineural dexamethasone with local anesthetics prolongs sensory blockade, effectively reducing postoperative pain intensity and opioid consumption. Its analgesic effects likely stem from anti-inflammatory mechanisms, including supression of proinflammatory cytokines, induction of anti-inflammatory cytokines, reduced prostaglandin synthesis, and decreased neuronal excitability 5 6. Adjuvant dexamethasone provides additional benefits, including prolonged analgesia, reduced pain scores, lower postoperative opioid requirements, and decreased inflammation in patients undergoing lumbar laminectomy. Prior literature has not examined the benefits of dexamethasone as an adjuvant for lumbar ESP block, nor measured and compared inflammatory biomarkers with its use. Therefore, this study investigates the efficacy of dexamethasone adjuant in ESP block for lumbar laminectomy surgery by assessing postoperative prostaglandin E2 levels, analgesia duration, pain scores (VAS) at 8, 12, 16, and 24 hours postoperatively, and patient-controlled analgesia (PCA) fentanyl requirements at the same intervals.
NCT07413302
Lumbar disc herniations may result in lower limb weakness. In such cases, there is a strong indication for surgical intervention through microdiscectomy. This clinical study aims to investigate preoperative factors that may influence the postoperative outcomes of patients undergoing this procedure.
NCT05029726
Opioid overuse is a widespread public health crisis in the United States with increasing rates of addiction and overdose deaths from prescription opioids. Reducing the need for opiate analgesics in the post-operative setting has become a high priority in minimizing long-term opioid use in surgical patients. This study will serve to demonstrate the efficacy of the addition of regional analgesic techniques in reducing post-operative opioid requirements in patients undergoing common lumbar spinal surgical procedures.
NCT07400068
This prospective observational study aims to evaluate the clinical outcomes of patients with single-level lumbar disc herniation who undergo routine percutaneous laser disc decompression (PLDD). In routine clinical practice, some patients receive an additional transforaminal anterior epidural steroid injection during the same session without an extra puncture. This study will prospectively follow patients who receive PLDD alone and those who receive PLDD combined with epidural steroid injection. Pain intensity, functional status, analgesic use, need for additional interventions, and complications will be assessed over time. The results may help to clarify whether adding epidural steroid injection to PLDD improves clinical outcomes in patients with lumbar disc herniation.
NCT07397286
The study is designed as a double-blind, prospective, randomized controlled trial. Blindness is ensured by having different researchers performing the interventional procedures and monitoring the pain diaries, thus preventing them from knowing which procedure is performed on which patient. Patient randomization will be performed using computer assistance. After obtaining approval from the hospital ethics committee, clinical trials will be initiated. Patients who present to the Department of Neurology, Algology Division, ADÜTF between 2025-2026 and undergo DRG-PRF and TFAESI for radicular pain due to cervical disc herniation will be divided into two groups. Patients in Group 1 will undergo DRG-PRF and TFAESI with the addition of local anesthetic. Patients in Group 2 will undergo DRG-PRF and TFAESI without the addition of local anesthetic. During the study, NRS score measurements will be taken to assess pain intensity in patients in both Group 1 and Group 2 before the procedure and at 1, 3, and 6 months post-procedure follow-ups. Neurological and musculoskeletal examinations will be performed during routine check-ups before the procedure and at 1, 3, and 6 months after the procedure, and any developing side effects will be recorded.
NCT06763224
Chronic neuropathic pain following lumbar spine surgery is often under-diagnosed and difficult to relieve. It can persist long after the operation, sometimes for months or even years, and has a major impact on the quality of life of patients who suffer from it. However, the scientific literature on the subject remains relatively poor, as evidenced by the absence of scientific studies on the prevalence of neuropathic pain after lumbar spinal surgery, whether instrumented or not. The main aim of this study is to determine whether lumbar spine surgery has an impact on the prevalence of neuropathic pain. Participants will be followed up and complete a quality-of-life questionnaire for one year after surgery.
NCT07349719
Postoperative pulmonary complications are a frequent cause of morbidity following lumbar stabilization surgery. Conventional ventilation strategies may not adequately reflect intraoperative changes in respiratory mechanics, potentially leading to impaired postoperative pulmonary function. Dynamic compliance-guided ventilation provides a real-time, individualized approach by adjusting ventilatory parameters according to lung compliance. This prospective randomized controlled study aims to evaluate the effects of dynamic compliance-guided ventilation compared with standard ventilation strategies on postoperative pulmonary function in patients undergoing lumbar stabilization surgery. Eligible patients will be randomly assigned to either the compliance-guided group or the conventional ventilation group. In this study, the investigators aim to prospectively compare ventilation with the dynamic compliance (Cdyn) approach-one of the lung-protective ventilation strategies-with conventional ventilation methods in patients undergoing surgery in the prone position. The primary outcome will be evaluated using a modified lung ultrasound scoring system based on the most severely affected regions of aeration loss. Secondary objectives include the assessment of intraoperative hemodynamics, respiratory mechanics, and the effects on postoperative pulmonary function.
NCT07367191
Transforaminal epidural steroid injection (TFESI) is a commonly used minimally invasive procedure for the treatment of lumbar radicular pain secondary to disc herniation. Although TFESI has been shown to provide significant pain relief in a substantial proportion of patients, the onset, duration, and temporal pattern of pain relief after the procedure vary considerably among individuals. The relationship between early pain response patterns and long-term treatment success remains poorly understood. This prospective observational study aims to evaluate whether temporal changes in pain intensity following TFESI, particularly during the early post-procedural period, are associated with clinical treatment success at mid- and long-term follow-up. Pain intensity will be assessed using the Numeric Rating Scale (NRS) at predefined time points following the procedure, and treatment success will be defined as a ≥50% reduction in NRS score compared with baseline.
NCT06023719
The goal of this clinical investigation is to learn about DISC Care, an Hernia Blocking System, in patients who have undergone lumbar disc hernia surgery. The main questions it aims to answer are: * if the implant (DISC Care) prevents disc herniation recurrence * if DISC Care is a safe device Participants will be implanted with DISC Care and followed up for two years (7 visits).
NCT07312747
\- To compare the clinical outcomes of bilateral straight cages and unilateral banana cage insertion in lumbar interbody fusion surgery, assess radiological outcomes, including intervertebral disc height, lumbar lordosis angle, and radiographic evidence of fusion, evaluate the rate of complications, such as cage migration, subsidence, pseudoarthrosis, and adjacent segment degeneration and analyze differences in operative time, blood loss, and length of hospital stay between the two techniques
NCT05066711
The primary objective of this study is to evaluate the safety and performance of anterior cervical spine surgery using the NuVasive anterior cervical plate (ACP) System as measured by reported complications, radiographic outcomes, and patient-reported outcomes (PROs).
NCT05808140
In endoscopic spinal nerve root decompression surgery, the intraoperative nerve exploration is time-consuming and critical. According to statistics, the incidence of nerve root injury under spinal endoscope is 1.8-2.5%. Damage to nerve roots may lead to postoperative sensory retardation and motor weakness, thereby impairing the physical function of patients. A real-time auxiliary intraoperative nerve identification technology is necessary. In this prospective, open-label, randomized, parallel controlled trial, 40 patients who undergo endoscopic spinal surgery are included. Subjects are randomly divided into control group and low, medium and high Indocyanine green(ICG) preoperative administration experimental group. Standard endoscopic spinal surgery is performed in the control group. Patients in the experimental group received an intravenous injection of ICG before surgery, and a standard endoscopic spinal surgery is performed with the use of a fluoroscopic endoscopic surgical imaging system to assist the surgeon in identifying and protecting the nerve roots. The main objectives of this experiment are (i) to explore the safety and feasibility of ICG fluorescence imaging to assist in nerve root identification during endoscopic spinal surgery and (ii) the effectiveness of this technique for endoscopic search for nerve roots. The secondary objective is to explore the optimal ICG dosing regimen.
NCT07139847
This randomized, double-blind, controlled trial investigates the effect of intraoperative magnesium sulfate infusion on the incidence of postoperative emergence agitation in adult patients undergoing elective lumbar microdiscectomy under general anesthesia. Eligible participants (ASA physical status I-II, aged 18-70 years) will be randomly assigned to receive either magnesium sulfate or 0.9% saline during surgery. The primary outcome is the incidence of emergence agitation in the post-anesthesia care unit (PACU), assessed at admission and at 5, 10, 15, and 30 minutes using the Ramsay Sedation Scale. Secondary outcomes include postoperative pain scores (Numeric Rating Scale), intraoperative remifentanil consumption, recovery and extubation times, tramadol use in the PACU, and any adverse events related to magnesium infusion.
NCT07250581
The goal of this study is to explore the indications and application scope of spinal endoscopy combined with annulus fibrosus repair technology, with a focus on verifying the effectiveness of annulus fibrosus suture technology and evaluating its safety, so as to further support the promotion of annulus fibrosus repair technology in patients with lumbar disc herniation.
NCT06853132
The purpose of this study is to improve symptoms of Lumbar Disc Herniation (LDH) and Osteoporosis (OP) by implementing an evidence-based Baduanjin exercise to reduce pain and increase muscle strength and quality of life in Chinese patients. This study will provide new sights of exercise of elderly patients with LDH and OP for elderly patients.
NCT06615518
The goal of this clinical trial is to compare the clinical effectiveness of Full Endoscopic Lumbar Discectomy (FELD) and Microdiscectomy (MD) in patients aged 18-85 with single-level lumbar disc herniation who have not undergone prior lumbar surgery. This study also aims to perform a radiological analysis of MRI scans before and after treatment to optimize patient selection and surgical strategies. The main questions it aims to answer are: * Does FELD provide superior early postoperative pain relief (measured by VAS) compared to MD? * Does FELD offer better functional recovery (measured by COMI and ODI scores) postoperatively compared to MD? * Can radiological analysis of pre- and post-operative MRI images help optimize patient qualification and guide surgical strategies? Researchers will compare patients undergoing FELD to those undergoing MD to see if endoscopic techniques result in faster recovery and lower early postoperative pain while maintaining similar long-term outcomes. The study will also analyze how MRI findings correlate with clinical outcomes to refine operative decision-making. Participants will: * Undergo either FELD or MD surgery * Complete VAS, COMI, and ODI questionnaires at pre-specified follow-up intervals (1, 3, 6, and 12 months post-surgery) * Have MRI scans 24 hours before surgery, 24 hours after surgery, and at each follow-up to assess disc recurrence, residual pathology, and to optimize surgical strategies.
NCT07203560
The objective of this randomized controlled trial was to investigate the effects of neurodynamic mobilization on pain intensity, normal joint motion, neurodynamics, functional level, and disability in patients with lumbar disc herniation.
NCT07204197
The goal of this clinical trial is to evaluate the effectiveness of virtual reality-assisted physical therapy in the acute postoperative period after lumbar disc surgery. The main questions it aims to answer are: * Does virtual reality-assisted physical therapy reduce pain more effectively than conventional physical therapy? * Does it improve functional recovery, pain threshold, and blood biomediator levels? * Does it reduce anxiety and kinesiophobia in the early rehabilitation period? Researchers will compare virtual reality-assisted physical therapy with standard physical therapy to determine whether virtual reality provides additional therapeutic benefits. Participants will: * Undergo standard postoperative physical therapy after lumbar disc surgery. * Some participants will additionally perform virtual reality-based rehabilitation exercises. * Be evaluated for pain severity, functional improvement, blood biomediators, pain threshold, and psychological outcomes.