Clinical trials: Sternotomy
Sternotomy
STERN FIX Device As a Sternal Fixation System
Pre-market clinical research, prospective, single-arm that aims to assess the sternal sealing in patients in which the sternum has been fixed with the STERN FIX system.
- Trial name
- NCT04593732
- Testing
- STERN FIX (Sternal Stabilization System)
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- NEOS Surgery
Bypass Surgery, Arrythmia
Parasternal Intercostal Plane Catheter for Pain Control After CABG Surgery
Coronary artery bypass graft (CABG) surgery performed via sternotomy (incision of the breastbone) can cause severe pain after surgery; this can slow recovery and increase the need for opioid pain relievers.
- Conditions
- Bypass Surgery, Arrythmia, Postoperative Pain
- Trial name
- PIP-PAIN (NCT07759570)
- Testing
- Parasternal blocks
- Where
- Turkey (Türkiye)
- Volunteers
- 56 people
- Sponsor
- Koc University Hospital
Chronic Pain, Postoperative, Sternotomy Pain
Early Screening of Chronic Post-sternotomy Pain Using the DN4-i Questionnaire
Chronic post-sternotomy pain (CPSP) is a common complication after cardiac surgery, with a reported prevalence between 30% and 50%.
- Trial name
- DEPDN4i (NCT07603271)
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Institute Arnault Tzanck, France
Ischemic Cardiopathy, Other Forms of Cardiopathy
Dysesthesia Study After Sternotomy
Chronic pain associated to sternotomy occurs in 40 to 50% of patients after cardiac surgery. 33 to 66% of these patients suffer during 3 month and 25 to 33% have postoperative pain for at least 1 year.
- Trial name
- NCT00408044
- Testing
- cardiac surgery with sternotomy
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Pain Reliefe
Effective Postoperative Pain Treatment After Sternotomy. Comparison of the Erector Spinae Plane Block vs Conventional Opioid Treatment
Comparison of effect between Erector Spinae plane block and conventional opioid treatment after cardiac surgery
- Trial name
- VUSCH/POPT1 (NCT03915301)
- Testing
- Satisfaction assessed by the VAS [followed by its scale information in the Description]
- Where
- Slovakia
- Volunteers
- 40 people
- Sponsor
- Pavol Jozef Safarik University
Aortic Valve Stenosis, Heart Valve Diseases
Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement
This is a single-center, open-label, randomized controlled trial. Patients scheduled for aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be eligible.
- Trial name
- NCT02272621
- Testing
- Minimally invasive aortic valve replacement, Full sternotomy aortic valve replacement
- Where
- Sweden
- Volunteers
- 100 people
- Sponsor
- Karolinska University Hospital
Chronic Pain, Sternotomy
Remifentanil vs Fentanyl During Cardiac Surgery and Chronic Thoracic Pain
This study will investigate the influence of intra-operative use of remifentanil versus fentanyl on the percentage of patients with chronic thoracic after cardiac surgery via sternotomy.
- Conditions
- Chronic Pain, Sternotomy, Remifentanil, Fentanyl
- Trial name
- REFLECT (NCT02031016)
- Testing
- Fentanyl, Remifentanil
- Where
- Netherlands
- Volunteers
- 126 people
- Sponsor
- St. Antonius Hospital
Congenital Heart Defect, Congenital Heart Disease
Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) Study
The erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block.
- Conditions
- Congenital Heart Defect, Congenital Heart Disease, Anesthesia, Local, Opioid Use
- Trial name
- NCT03611374
- Testing
- Bilateral Erector Spinae Plane Block (ESPB)
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Stanford University
Postoperative Pain, Cardiac Surgery
Comparison of Paravertebral Block and Deep Parasternal Intercostal Plane Block in Cardiac Surgery
Median sternotomy is commonly used in cardiac surgery and is often associated with significant postoperative pain. Poor pain control after sternotomy may increase opioid use, delay mobilization, prolong extubation time, and…
- Conditions
- Postoperative Pain, Cardiac Surgery, Postoperative Pain After Cardiac Surgery Via Median Sternotomy
- Trial name
- SPARE-CABG (NCT07498946)
- Testing
- Thoracic paravertebral block (TPVB), Bilateral Deep Parasternal Intercostal Plane Block
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people
- Sponsor
- Gaziantep City Hospital
Sternotomy Closure,Open Heart Surgery
Adjustable Carbon Fiber Sternal Plates for Sternotomy Closure
The goal of this clinical trial is to learn if a new medical device (SC03 plates) to close the sternum after a sternotomy in patients that have been operated of a cardiac surgery, is safe and effective.
- Trial name
- FIX IT ALL (NCT07366203)
- Testing
- SC03 Plating system, Stainless steel wires
- Volunteers
- 190 people
- Sponsor
- NEOS Surgery
Pain, Postoperative
Parasternal Subpectoral Plane Blocks for Cardiac Surgery Via a Midline Sternotomy
To better determine whether parasternal subpectoral plane blocks (PSPB) infusing bupivacaine for midline sternotomy decreases opioid consumption and pain scores.
- Trial name
- NCT04788056
- Testing
- Parasternal Subpectoral Plane Block
- Sponsor
- Brigham and Women's Hospital
Frailty, Coronary Artery Disease
Funcional Recovery After Minithoracotomy or Sternotomy for CABG in Frail Patients
Frailty is a major predictor of adverse outcomes following coronary artery bypass grafting (CABG), being associated with increased postoperative complications, prolonged hospitalization, delayed functional recovery, and reduced…
- Conditions
- Frailty, Coronary Artery Disease, Coronary Artery Bypass Graft (CABG)
- Trial name
- MINIFRAGILE (NCT07742475)
- Testing
- Minimally Invasive Coronary Artery Bypass Grafting (MICS-CABG), Conventional Coronary Artery Bypass Grafting (Median Sternotomy)
- Volunteers
- 194 people
- Sponsor
- University of Sao Paulo General Hospital
Cardiac Septal Defects With Coarctation of the Aorta, Mitral Regurgitation
Comparison of Erector Spinae Block and Pecto-Intercostal Facial Block For Enhanced Recovery in Adult Cardiac Surgery
The current study is designed to compare the perioperative analgesic efficacy of Erector spinae plane block (ESPB) and Pecto-intercostal-fascial plane block (PIFB) in adults undergoing cardiac surgery via median sternotomy.
- Trial name
- NCT05475561
- Testing
- Ultrasound guided Pecto-intercostal- fascial plane block, Ultrasound guided erector spinae plane block, Bupivacain
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Alexandria University
Pneumonia, Cardiac Surgery
Catheter Outcomes With Sternotomy Cardiac Operated
Pneumonia occurs frequently in patients undergoing cardiac surgery and allows to increase their mortality. While chest physical therapy plays a crucial role to prevent postoperative pneumoniae, painful mobilization of the sternum…
- Conditions
- Pneumonia, Cardiac Surgery, Multiperforated Catheter, Analgesia
- Trial name
- STERNOCAT (NCT01648777)
- Testing
- L bupivacaine
- Where
- France
- Volunteers
- 1,502 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Sternotomy
Sternal Fixation With STERN FIX After Medial Sternotomy
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.
- Trial name
- NCT05784532
- Testing
- STERN FIX
- Where
- United States
- Sponsor
- NEOS Surgery
Pain, Postoperative
Gabapentin for Postoperative Pain Management After Cardiac Surgery With Median Sternotomy
In this study we will focus on the postoperative recovery. A successful postoperative recovery should bring the patient to at least to the pre-surgical level.
- Trial name
- NCT00572208
- Testing
- Gabapentin group
- Where
- 2 sites in Denmark
- Volunteers
- 64 people
- Sponsor
- Aarhus University Hospital
Sternotomy, Cardiovascular Diseases
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…
- Conditions
- Sternotomy, Cardiovascular Diseases, Physical Inactivity, Quality of Life
- Trial name
- T-REX Twente (NCT06115759)
- Testing
- T-REX Twente precautions, Usual (restrictive) sternal precautions
- Where
- Netherlands
- Volunteers
- 154 people
- Sponsor
- Medisch Spectrum Twente
Heart; Surgery, Heart, Functional Disturbance as Result, Pain, Postoperative
Development of Open Heart Surgery Patient Care Protocol and Its Effect on Post-sternotomy Pain
Open heart surgery method is generally used in the treatment of cardiovascular diseases. Sternotomy is the process of opening the sternum. After sternotomy, individuals experience ongoing pain in the anterior thorax.
- Conditions
- Heart; Surgery, Heart, Functional Disturbance as Result, Pain, Postoperative, Nursing Caries
- Trial name
- NCT05902052
- Testing
- Care Protocol
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Kutahya Health Sciences University
Chronic Poststernotomy Pain
Bilateral Pecto-Intercostal Fascial Plane Block for Prevention of Chronic Poststernotomy Pain After CABG
This single-center, prospective, parallel-group randomized controlled trial will evaluate whether adding ultrasound-guided bilateral single-shot pecto-intercostal fascial plane block (PIFB) to standard multimodal systemic…
- Trial name
- NCT07882836
- Testing
- Pecto-Intercostal Fascial Plane Block, Standardized Multimodal Systemic Analgesia
- Where
- Turkey (Türkiye)
- Volunteers
- 180 people
- Sponsor
- Izmir Katip Celebi University
Surgical Wound Infection
Effects of Showering in 48-72 Hours of Median Sternotomy on Wound Infection, Pain, Comfort and Satisfaction
Time of showering after surgery is still a controversial issue for surgical patients and health professionals. It has been reported that patients should not shower until sutures are removed since traditionally showering is…
- Trial name
- NCT04250961
- Testing
- postoperative early shower
- Where
- Turkey (Türkiye)
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Pamukkale University