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Showing 1-20 of 719 trials
NCT07139847
In this retrospective study, the effect of intraoperative magnesium sulfate infusion on the incidence of postoperative emergence agitation was evaluated in adult patients who underwent elective lumbar microdiscectomy under general anesthesia. The medical records of patients aged 18-70 years with an ASA physical status of I-II were retrospectively reviewed. Patients were evaluated according to whether they received intraoperative magnesium sulfate infusion as part of anesthetic management. The primary outcome measure was the incidence of emergence agitation in the post-anesthesia care unit; this assessment was based on Ramsay Sedation Scale scores recorded in the post-anesthesia care unit at admission and at 5, 10, 15, and 30 minutes. Secondary outcome measures included postoperative pain scores assessed using the Numeric Rating Scale, intraoperative remifentanil consumption, recovery and extubation times, tramadol requirement in the post-anesthesia care unit, and possible adverse events related to magnesium infusion.
NCT04096170
We aim to study the impact of perioperative IV lidocaine on postoperative pain control in patients undergoing paraesophageal hernia repair. This is in the context of an established ERAS protocol. We wish to study the effect of IV Lidocaine on postoperative short and long-term outcomes, including patients' length of stay postoperative mortality, morbidity, and quality of life. We will compare this to our standard pain management.
NCT07639671
This prospective single-center study aims to evaluate the clinical efficacy of fluoroscopy-guided cervical interlaminar epidural steroid injection (CIESI) in patients with unilateral, single-level cervical radiculopathy due to cervical disc herniation. Unlike previous studies that assessed neck and arm symptoms separately, this study uses the Cervical Radiculopathy Impact Scale (CRIS) as the primary outcome measure to simultaneously evaluate cervical and upper extremity symptoms and their functional impact. A total of 98 patients resistant to conservative treatment will be assessed at baseline, 3 weeks, and 3 months after CIESI using CRIS, Numeric Rating Scale (NRS), Neck Disability Index (NDI), and QuickDASH scores. The primary outcome is improvement in CRIS scores following the intervention, while secondary outcomes include changes in pain intensity and functional disability. The study seeks to determine whether CRIS provides a more comprehensive and clinically meaningful assessment of treatment response in cervical radiculopathy.
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.
NCT07608653
The goal of this clinical trial is to learn if a laparoscopic surgery called Transabdominal Preperitoneal (TAPP) repair is safe and works well for adults with a recurrent inguinal hernia (a groin hernia that has returned after a previous operation). The main questions it aims to answer are: Does the TAPP technique lower the number of complications after surgery? How well do participants recover during the early postoperative period and long-term follow-up? Fixing a hernia that has returned is hard because of old scar tissue. In this study, researchers will use the TAPP technique to work through a different layer of tissue to provide a stronger repair. Participants will: Undergo the TAPP laparoscopic surgery for their recurrent hernia. Visit the clinic for close health monitoring shortly after surgery. Complete regular follow-up checkups to track their long-term recovery.
NCT07602647
To evaluate the clinical characteristics, postoperative outcomes, and factors associated with Clavien-Dindo grade ≥II complications in nonagenarians undergoing elective inguinal hernia repair. Preoperative, intraoperative, and postoperative data of nonagenarians who underwent elective inguinal hernia repair were collected. The primary outcome was Clavien-Dindo grade ≥II complications. Univariable logistic regression was used to identify associated factors.
NCT06155253
The goal of this clinical trial is to compare the effects of single-level and bi-level erector spinae plane block in open inguinal hernia repair surgery. The main question it aims to answer are: * Whether bi-level ESP block will improve pain control after open inguinal hernia repair surgery * Whether bi-level ESP block will improve quality of recovery after open inguinal hernia repair surgery Participants will receive erector spinae plane block, and will be randomised into 2 groups, single-level ESP block and bi-level ESP block, before open hernia repair surgery. They will be followed up after operation for assessment of pain control and quality of recovery.
NCT05953428
This is a prospective randomized, double-blinded, controlled trial that will enroll 75 subjects undergoing laparoscopic hiatal hernia repair surgery. Participants who meet eligibility criteria will be randomized in a 1:1 ratio to receive either the opioid sparring anesthesia protocol (OSA) or the opioid based anesthesia protocol (OBA). The purpose of this study is to investigate if an opioid sparring protocol for laparoscopic hiatal hernia repair will reduce opioid consumption during discharge. Other outcomes include: postoperative VAS scores (PACU arrival, PACU discharge, hospital discharge), total in hospital opioid consumption, PACU length of stay, incidence of postoperative nausea and vomiting (PONV in PACU, postoperative day 1, during hospital stay), rehospitalization rate, rate of reoperation, rate of emergency room visit, surgeon satisfaction, and hospital cost differential.
NCT05424484
The purpose of this prospective, pivotal, multi-center, single-arm, pre-market, investigational clinical study is to assess the safety and performance of Deternia™ Self-Gripping Resorbable Mesh when used for suture line reinforcement after midline laparotomy in clean and clean-contaminated fields (CDC Classification I and II). Data from this study will be used to support market applications and European post-market clinical follow-up needs (PMCF). The indication under investigation is reinforcement of midline laparotomy to limit the rate of incisional hernia (IH) in clean and clean-contaminated surgeries (CDC Classification I and II).
NCT05444751
The purpose of this study is to determine the optimal anesthetic routine for lumbar decompression surgery. General Anesthesia is the standard of care in spine surgery. Spinal anesthesia in decompressive procedures can be the new standard of care. Recently, it has been found that regional analgesia is option that has been shown to improve pain and opioid-related outcomes after spine surgery, but has not yet been studied in combination with spinal anesthesia. This is study that consists of two groups: standard of care general anesthesia with a nerve block and a spinal anesthesia with nerve block. Patients are randomized to either of the two groups. There will be 71 patients enrolled in each group for this study.
NCT07544238
The participating researchers register all adult patients (who have given informed written consent) scheduled for elective repair of an abdominal wall hernia (NOT inguinal hernias) via minimally invasive operation technique (i.e.: laparoscopy or robotic repair) and perform a follow up of 5 years to analyze clinical outcome parameters. These parameters include recurrence of the hernia, intra- and postoperative complications, quality of live, esthetic outcome and pain. The patients will be reviewed in person by the participating researchers at 2-3 moths, 1 year, 3 years and 5 years after surgery. A computed tomography will be performed at 1 year after surgery and in case of suspicion of complications, for example hernia recurrence. The treatment and follow-up of the participating patients does not differ from the standard treatment protocol (and the not participating patients).
NCT07360691
This prospective, single-arm clinical study evaluates the safety, feasibility, and early clinical outcomes of High-Purity Type I Collagen (HPTC; Surgicoll-Mesh®) when used as a biologic reinforcement in selected hernia repair scenarios where permanent synthetic mesh placement is undesirable. Outcomes focus on early postoperative safety, wound healing, and complication profiles over an 8-week follow-up period.
NCT07166172
This registry study aims to confirm that FETO increases neonatal survival to discharge and reduces long-term morbidity in fetuses with isolated left CDH and o/e LHR \< 30%, or isolated right CDH and o/e LHR ≤ 45%, compared to those receiving standard care. This prospective registry plans to enroll 80 pregnant women (40 treatment/40 control) with fetuses diagnosed with isolated CDH, and the children will be followed for up to 24 months.
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.
NCT07509580
Lumbar radiculopathy caused by conditions such as lumbar disc herniation (LDH) and lumbar spinal stenosis (LSS) can lead to chronic pain and reduced quality of life. In patients who do not respond to conservative treatments, minimally invasive procedures such as transforaminal epidural steroid injection (TFESI) and pulsed radiofrequency (pRF) applied to the dorsal root ganglion (DRG) are commonly used. This study aims to compare treatment responses between patients with lumbar disc herniation and those with lumbar spinal stenosis who have undergone TFESI combined with dorsal root ganglion pulsed radiofrequency. Pain levels and clinical outcomes will be evaluated to determine whether the underlying condition affects treatment effectiveness. The results of this study may help guide clinicians in selecting the most appropriate treatment approach for patients with lumbar radiculopathy.
NCT05306496
The purpose of this study is to evaluate the safety and performance of the 4DMESH® used in (robot-assisted) laparoscopic inguinal and femoral hernia repair. The goal of the study will be achieved by assessing the prevalence of recurrences, pain, quality-of-life (QoL), return to daily activities and work and groin symptoms, and by reporting of peri- and postoperative complications in a prospectively maintained database.
NCT07531485
Before lumbosacral decompression surgery for radicular pain, selective nerve root block(SNRB) is a common procedure to identify the responsible compressed nerve root(RCNR) and predict surgical outcomes. However, the diagnostic accuracy of conventional SNRB is unsatisfactory, especially in terms of specificity. The main limitation is the uncontrolled distribution of anesthetics during injection: when anesthetics spread to surrounding soft tissues instead of acting directly on the RCNR, false-negative results may occur with persistent radicular pain; when anesthetics diffuse to two or more nerve roots including the RCNR, false-positive results may occur even if a normal nerve root is punctured, leading to misdiagnosis. This study aims to evaluate the diagnostic accuracy of a novel three-dimensional computed tomography multiplanar volume reconstruction (3D-CT MPVR) guided selective intraperineural nerve root block(SINRB) for identifying the RCNR in patients with lumbosacral radicular pain. The investigators hypothesize that this technique will achieve higher diagnostic specificity and overall accuracy than conventional SNRB, by ensuring anesthetics are delivered directly to the target nerve root. This improvement will help clinicians make more accurate surgical plans, achieve better targeted decompression, and ultimately improve postoperative pain relief and functional recovery for patients. The main research questions to be addressed in this study are: * What is the procedural success rate of SINRB? * Whether SINRB may cause clinically detectable nerve injury? * Whether sciatica is relieved after SINRB when only the responsible compressed nerve root is blocked? * Whether sciatica is relieved after SINRB when only a normal unaffected nerve root is blocked? Participants will: * Undergo one or two SINRB procedures and a single-level lumbar decompression surgery * Get assessment of pain, mobility disorder and neurological function
NCT07530159
This prospective observational study aims to evaluate the clinical outcomes and cost-effectiveness of retromuscular midline ventral hernia repair using open, laparoscopic and robotic approaches. Patients undergoing elective repair are included and followed to assess postoperative complications, length of hospital stay, recurrence and quality of life. In addition, a cost-effectiveness analysis will be performed from the perspective of the Spanish National Health System. The study is currently ongoing.
NCT04282720
Prospective, single-arm, open-label study to evaluate re-occurrence and quality of life in subjects undergoing primary Hiatal hernia repair using SurgiMend biological mesh. Up to 15, with a target of 10, subjects are planned to be enrolled at one site. All subjects will receive the SurgiMend mesh during surgery. Data collected will be compared to historical data. Subjects will complete a pre-operative visit. After surgery, in addition to any standard of care visits, subjects will complete 3- and 6-month follow-ups involving a phone QOL survey and will have an upper GI series at 6 months.
NCT07261189
This randomized controlled trial aims to compare postoperative pain between staples and polypropylene sutures used for mesh fixation in patients undergoing elective Lichtenstein tension-free inguinal hernia repair.