View clinical trials related to Sternotomy.
Filter by: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).
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.
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.
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.
Researchers hope to learn whether giving the longer-acting local anesthetic liposomal bupivacaine prior to closing the sternum is more effective in managing pain following sternotomy, than in patients who received standard bupivacaine before sternal closure. Researchers will measure this based on how much IV pain medication is used, rates on confusion, and time to remove the breathing tube.