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Tundra lists 4 Patient Outcome Assessment clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.
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NCT07510269
Investigation of the Effects of Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block on Perioperative Analgesia Management in Patients Scheduled for Mastectomy
This study aims to evaluate and compare the analgesic efficacy of two ultrasound-guided regional anesthesia techniques, the serratus anterior plane (SAP) block and the serratus posterior superior intercostal plane (SPSIP) block, in patients undergoing elective mastectomy surgery. Postoperative pain following mastectomy is a common and significant clinical problem that negatively affects patient comfort, delays mobilization, and may prolong hospital stay. Although systemic analgesics are commonly used, they are associated with adverse effects such as sedation, constipation, and potential dependency. In this randomized clinical study, female patients aged 18-75 years with ASA physical status I-III scheduled for elective mastectomy will be included after obtaining informed consent. Patients will be allocated into two groups to receive either SAP block or SPSIP block under ultrasound guidance prior to surgery. Standardized general anesthesia and perioperative analgesia protocols will be applied to all patients. The primary objective is to compare postoperative pain scores between the two groups using the Numeric Rating Scale (NRS). Secondary outcomes include time to first analgesic requirement, total analgesic consumption, intraoperative opioid use, and hemodynamic parameters. By comparing these two interfascial plane blocks, this study aims to identify a more effective analgesic technique that improves postoperative pain control, enhances patient comfort, and facilitates early mobilization following mastectomy.
Gender: FEMALE
Ages: 18 Years - 75 Years
Updated: 2026-04-03
1 state
NCT07452627
Comparison of the Efficacy of Combined Transversus Thoracic Plane Block and Serratus Anterior Plane Block Versus Erector Spinae Plane Block in the Management of Sternotomy Pain
Background and Purpose: Median sternotomy is the standard surgical approach for cardiac procedures, yet it is associated with significant postoperative pain. Inadequate pain management can lead to pulmonary complications and chronic pain syndromes. While opioids are a cornerstone of multimodal analgesia, their side effects-such as sedation, respiratory depression, and nausea-can delay recovery. Furthermore, neuraxial techniques like epidural analgesia are often avoided in cardiac surgery due to the risks associated with systemic heparinization. This study aims to compare the efficacy of two non-neuraxial regional anesthesia techniques: the combination of Transversus Thoracic Plane Block (TTPB) and Serratus Anterior Plane Block (SAPB) versus the Erector Spinae Plane Block (ESPB). Study Design and Population: This prospective, randomized study includes 50 patients (ASA I-III, aged 18-80) undergoing elective cardiac surgery via median sternotomy. Patients are randomized into two groups: TTPB + SAPB Group: Patients receive ultrasound-guided blocks targeting the anterior and lateral chest wall. ESPB Group: Patients receive ultrasound-guided blocks targeting the paravertebral and intercostal spaces from a posterior approach. Intervention and Procedures: Following standardized anesthesia induction and invasive monitoring, the respective blocks are performed under ultrasound guidance. Intraoperative hemodynamic data are recorded at key surgical stages (incision, sternotomy, CPB). In the postoperative period in the intensive care unit (ICU), all patients will receive a standardized multimodal analgesia protocol including intravenous (IV) paracetamol and IV tenoxicam. While patients are intubated, pain will be assessed using the Behavioral Pain Scale (BPS). If the BPS score is above 3, IV fentanyl will be administered as rescue analgesia. Following extubation, pain levels will be evaluated using the Visual Analog Scale (VAS) at rest and during coughing at specific time points (0, 1, 2, 4, 8, 12, 16, and 24 hours). If the post-extubation VAS score is 4 or higher, intramuscular meperidine will be given as rescue analgesia. Additionally, IV ondansetron will be administered in case of nausea or vomiting. The study will also evaluate the time to extubation, time to clinical transport, and patient/surgeon satisfaction using a 5-point Likert scale. Primary and Secondary Outcomes: The primary objective of this study is to compare postoperative pain intensity between the study groups using the Visual Analog Scale (VAS) (0-10) and the Behavioral Pain Scale (BPS) (3-12). Secondary objectives include: Opioid Consumption: Comparison of total intraoperative and postoperative opioid (IV fentanyl and IM meperidine) consumption within the first 24 hours. Recovery Milestones: Measurement of time to extubation, time to first mobilization, and time to clinical transport to the surgical ward. Clinical Satisfaction and Safety: Assessment of patient and surgeon satisfaction using a 5-point Likert scale, and monitoring the incidence of opioid-related side effects, specifically postoperative nausea and vomiting (PONV) requiring ondansetron. Expected Impact: By identifying the most effective regional anesthesia technique (TTPB+SAPB vs. ESPB) in conjunction with a standardized multimodal analgesia protocol (IV paracetamol and tenoxicam), this study seeks to maximize postoperative pain control and patient comfort. The results aim to achieve superior analgesia with lower pain scores, thereby facilitating earlier mobilization, reducing the incidence of postoperative complications, and enhancing the overall recovery process for patients undergoing cardiac surgery via median sternotomy. This approach ultimately contributes to the development of more effective, pain-centered recovery protocols in the intensive care unit.
Gender: All
Ages: 18 Years - 80 Years
Updated: 2026-03-10
1 state
NCT05851989
Study on Prognosis of Acutely Ruptured Intracranial Aneurysms
The SPARTA study is a prospective multicenter observational trial in the Netherlands with the aim of identifying the best clinical care in patients with aneurysmal subarachnoidal haemorrhage. Differences in outcome between surgical treatment and endovascular treatment will be explored. Furthermore, cost effectiveness and radiological prognostic factors will be examined.
Gender: All
Ages: 18 Years - Any
Updated: 2025-03-25
NCT06434220
Effect of Predictive Model on ED Physician Assessments of Patient Disposition
The goal of this study is to measure the impact of fairness-aware algorithms on physician predictions of ED patient admission. Using an experimentally validated machine learning model tuned for equitable outcomes, the investigators quantify the impact of model recommendations on ED physician assessments of admission risk in a silent, prospective study. The investigators survey ED physicians who are not currently caring for patients using live site data. To quantify the impact of the model on ED physician assessments of admission risk, the investigators collect physician assessments before and after consulting the (original or updated) model prediction. The investigators measure ED physician adherence to model suggestions, along with the predictive accuracy and equity of downstream patient outcomes. The outcome of this study is an empirical measure of the extent to which fair ML models may influence admission decisions to mitigate health care disparities.
Gender: All
Ages: 18 Years - 65 Years
Updated: 2024-08-09