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8 clinical studies listed.

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Sternotomy

Tundra lists 8 Sternotomy clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.

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RECRUITING

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

Postoperative Pain
Sternotomy
Nerve Block
+1
RECRUITING

NCT07315308

Preoperative Deep Parasternal Intercostal Plane Block and Intraoperative Opioid Use in Cardiac Surgery

Median sternotomy is commonly used in cardiac surgery and is associated with significant intraoperative and postoperative pain, often requiring substantial opioid administration. High opioid use during cardiac surgery may contribute to adverse effects such as respiratory depression, delayed extubation, postoperative nausea and vomiting, and prolonged intensive care unit stay. Therefore, effective opioid-sparing strategies are an important component of modern perioperative care. The deep parasternal intercostal plane (DPIP) block is a regional anesthesia technique that targets the anterior cutaneous branches of the intercostal nerves, which are responsible for transmitting pain from the sternum and adjacent tissues. When performed under ultrasound guidance, this block allows precise local anesthetic deposition while minimizing the risk of pleural or vascular injury. The purpose of this randomized controlled study is to evaluate whether a preoperative ultrasound-guided DPIP block reduces intraoperative opioid consumption in adult patients undergoing elective cardiac surgery via median sternotomy. Patients will be randomly assigned to receive either a bilateral DPIP block in addition to standard general anesthesia or standard general anesthesia alone. The primary outcome of the study is total intraoperative opioid consumption. Secondary outcomes include time to extubation, postoperative opioid consumption within the first 24 hours, postoperative pain scores, and the incidence of opioid-related adverse effects. The results of this study may help define the role of the DPIP block as part of a multimodal, opioid-sparing analgesic strategy in cardiac surgery.

Gender: All

Ages: 18 Years - 65 Years

Updated: 2026-03-04

1 state

Postoperative Pain
Sternotomy
Opioid Consumption
+1
NOT YET RECRUITING

NCT07251881

SuperCable vs. Conventional Steel Wire for Closure After a Median Sternotomy

During certain heart surgeries, the sternum is opened and must then be closed securely. The study compares two closure methods - steel wires and SuperCable - in terms of stability, healing, and patient satisfaction. This investigation aims to demonstrate that the iso-elastic properties of the SuperCable Sternal Closure System result in faster sternal bone healing, reduced postoperative pain, shorter hospital stay, and improved physical recovery compared to conventional steel wire sternal closure. Eighty-six patients are participating and are randomly assigned to one of the two groups. After the operation, pain, healing, and possible complications are checked. The patients are examined 3 and 6 months after the operation.

Gender: All

Ages: 18 Years - Any

Updated: 2025-11-26

Sternotomy
ACTIVE NOT RECRUITING

NCT04985500

ESP/PIF for Sternotomy

This is a randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of two types of peripheral nerve blocks, specifically erector spinal plane (ESP) block and pecto-intercostal fascial (PIF) plane block. 90 subjects, from 18-85 years of age, undergoing cardiac surgery with median sternal incision will be enrolled at Mount Sinai Morningside Hospital Center. Study participation will last from the time of pre-operative evaluation to 72 hours after surgery. Subjects will be randomly assigned to receive 1 of the 3 different regimens at the beginning of surgery. Opioid consumption and pain scores after surgery will be evaluated. Though unlikely, risks include systemic absorption of local anesthetic, which can result in both central nervous system and cardiac toxicity.

Gender: All

Ages: 18 Years - 85 Years

Updated: 2025-07-15

1 state

Cardiac Surgery
Sternotomy
ACTIVE NOT RECRUITING

NCT06418100

Recto-intercostal Block for Coronary Artery Bypass Grafting

This interventional study aims to learn about the postoperative analgesic efficacy of a new fascial plane block, recto-intercostal fascial plane block, at coronary artery bypass grafting with sternotomy. There will be two groups, one of which will be the control group, and the other will be the study group randomly receiving postoperative recto-intercostal fascial plane block. The main questions it aims to answer are the effect of this new block on postoperative opioid consumption and pain scores. Also, postoperative outcomes related to respiratory ( postoperative oxygenation and atelectasis score), hemodynamic functions ( newly developed arrhythmias), total postanesthesia care unit stay, and hospital stay will be questioned.

Gender: All

Ages: 18 Years - 80 Years

Updated: 2025-03-19

1 state

Coronary Artery Disease
Peripheral Nerve Blocks
Sternotomy
RECRUITING

NCT06115759

RCT on T-REX Twente Regimen Effects on Quality of Life and Mobilisation for Cardiac Surgery Patients After Sternotomy

The goal of this study is whether the T-REX Twente precautions have a positive impact on the quality of life (MAcNew QLMI), level of physical activity, and reduction of fear of movement in heart patients after a total median sternotomy compared to the (current) standard precautions? Do these precautions also have no adverse effects on pain, wound healing, and/or postoperative complications? Participants will be instructed by the physiotherapist to both groups immediately postoperatively and are constantly repeated by the involved disciplines during the hospital stay. The control group is not allowed to lift, push, or pull for the first 6 weeks. There is little to no evidence for the current strict precautions currently implemented in the department. The intervention group receives the new T-REX Twente precautions, allowing for more independent activities through the use of the tube model (keeping elbows close to the sides). All patients receive three questionnaires (MacNew QLMI, Numeric Pain Rating Scale, and Tampa Scale for Kinesiophobia) preoperatively, on the 4th day postoperatively, on the first day of cardiac rehabilitation, and at the end of cardiac rehabilitation, taking approximately 10 minutes each time. Additionally, during the clinical admission immediately postoperatively, two AX3 accelerometers are placed on the patient, one lateroproximal on the right upper arm and one anterodistal on the right upper leg. Researchers will compare heart patients after a total median sternotomy with T-REX Twente precautions (intervention group) to the (current) standard precautions (control group).

Gender: All

Ages: 18 Years - Any

Updated: 2025-02-07

1 state

Sternotomy
Cardiovascular Diseases
Physical Inactivity
+2
RECRUITING

NCT06534372

Affecting Factors for Chronic Pain After Sternotomy

Chronic pain is common complication of surgery procedures. Rates of mortalits is getting lower in cardiac surgery. This situation has brought us to focus morbidity and long term life quality. Previous study show that chronic pain after cardiac surgery is experienced 11-40% patient. Multifactorial causes play a role in chronic pain etiology. The aim of our study is to determine the causes of chronic pain in patients who underwent sternotomy.

Gender: All

Ages: 18 Years - 80 Years

Updated: 2025-01-29

2 states

Cardiac Surgery
Sternotomy
Pain, Acute
+1
RECRUITING

NCT06476756

Combined Effects of Active Cycle Breathing Technique and Buteyko Technique in Post Sternotomy Patients

This randomized clinical trial seeks to compare the efficacy of the Active Cycle of Breathing Technique (ACBT) and Buteyko breathing techniques in sternotomy patients undergoing coronary artery bypass graft (CABG) surgery, aged 30 to 60. Data will be collected from Surgical Intensive Care Unit (ICU) in selected hospitals. Participants will be assigned to intervention to receiving ACBT and Buteyko breathing techniques standard protocol including chest percussion , tissue blowing exercises, incentive spirometer , cough technique, breathing control, deep breathing, and deep breathing techniques.

Gender: All

Ages: 40 Years - 60 Years

Updated: 2024-06-26

1 state

Sternotomy