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Sternotomy clinical trials

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NCT ID: NCT06418100 Recruiting - Clinical trials for Coronary Artery Disease

Recto-intercostal Block for Coronary Artery Bypass Grafting

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06153550 Completed - Sternotomy Clinical Trials

The Benefit of Preparation in Respiratory Physiotherapy Before a Sternotomy in the Context of Cardiac Surgery

Start date: September 1, 2021
Phase:
Study type: Observational

The sternotomy has some influence on the respiratory system after cardiac surgery, considerably increasing the risk of perioperative and postoperative breathing. There is respiratory preparation before cardiac surgery using local physiotherapeutic guidelines.

NCT ID: NCT06115759 Recruiting - Clinical trials for Cardiovascular Diseases

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

T-REX Twente
Start date: May 21, 2024
Phase: N/A
Study type: Interventional

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).

NCT ID: NCT05784532 Recruiting - Sternotomy Clinical Trials

Sternal Fixation With STERN FIX After Medial Sternotomy

Start date: April 1, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this single arm observational registry is to evaluate the safety and performance of the STERN FIX device in normal conditions of use, in patients treated with medial sternotomy according to the instructions for use. The main goal of this registry is to evaluate the sternal stability in patients who had their sternum fixed with the STERN FIX system. Participants will have their sternotomy closed with the STERN FIX device at the end of their cardiothoracic surgery and will be followed up as per standard of care. At discharge and at the 1 month FU visit the sternal stability will be assessed using the sternal instability scale (SIS).

NCT ID: NCT05676814 Completed - Analgesia Clinical Trials

Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients

Start date: March 24, 2023
Phase: Phase 4
Study type: Interventional

The purpose of this randomized, triple-blinded, prospective, feasibility study is to compare postoperative analgesia provided by Pecto-intercostal Fascial Block (PIFB) when performed with local anesthetic solution with or without perineural adjuvants in patients following cardiac surgery involving sternotomy. The study team hypothesizes that the patients receiving PIFB with bupivacaine with epinephrine, clonidine, and dexamethasone will have lower dynamic pain over the first 36 hours compared to those receiving PIFB with just bupivacaine and epinephrine.

NCT ID: NCT05357963 Recruiting - Postoperative Pain Clinical Trials

Incidence of Chronic Pain After Sternotomy

Start date: April 20, 2022
Phase:
Study type: Observational

Chronic postoperative pain is a well-known problem. Chronic postoperative pain is defined as pain that begins following a surgical procedure and persists for more than 2 months without other obvious causes such as infection or underlying disease. Sternotomy causes significant postoperative pain, and patients with chronic pain after sternotomy are often referred to pain clinics. The incidence of chronic pain after sternotomy ranges from 17% to 56%; In approximately one-third of these patients, chronic pain after sternotomy can compromise their quality of life by affecting their sleep patterns and impairing their ability to work. However, epidemiological studies on chronic pain after sternotomy are scarce. The aim of this study is to examine the incidence and possible risk factors of chronic pain following sternotomy operations. In this study, it was aimed to analyze the chronic pain findings of the patients who underwent sternotomy in the postoperative 3rd month.

NCT ID: NCT05356715 Completed - Postoperative Pain Clinical Trials

Erector Spinae Plane Block in Post-operative Recovery in Cardiac Surgery With Median Sternotomy.

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

This study aim is to measure the time of extubation in patients receiving ultrasound guided bilateral Erector Spinae Plane (ESP) block after cardiac surgery .

NCT ID: NCT05054179 Recruiting - Acute Pain Clinical Trials

Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain

Start date: September 7, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

One of the most painful aspects of open heart surgery is the incision made through the skin and the sternum to access the heart (a "sternotomy"). Post-sternotomy pain is a potentially debilitating complication of surgery that slows recovery immediately after surgery and can lead to issues with chronic pain. Previous research has shown that by injecting local anesthesia in the pecto inter-fascial plane, the space between the pectoralis major and the intercostal muscles, pain relief can be provided. The investigators aim to assess if repeated injections of local anesthesia via catheters is a useful adjunct compared to routine care.

NCT ID: NCT04985500 Recruiting - Cardiac Surgery Clinical Trials

ESP/PIF for Sternotomy

Start date: July 8, 2021
Phase: Early Phase 1
Study type: Interventional

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.

NCT ID: NCT04743895 Completed - Sternotomy Clinical Trials

Study Comparing Steel Wire to a Flat, Braided Suture to Close the Breastbone

Start date: January 4, 2021
Phase: N/A
Study type: Interventional

This pilot study is prospective, randomized, single-blinded, single-center for adult patients undergoing sternotomy closure after cardiac surgery. The clinical, patient-reported, and imaging outcomes will be measured comparing standard stainless steel wire (SSW) cerclage versus the FiberTape cerclage.