Clinical trials: Median Sternotomy
Congenital Heart Disease, Postoperative Pain After Cardiac Surgery Via Median Sternotomy
Comparison of Erector Spinae Plane Block and Modified Pectoral Fascial Plane Block for Postoperative Analgesia in Pediatric Cardiac Surgery
Postoperative pain management is an essential component of perioperative care in pediatric congenital cardiac surgery. Regional anesthesia techniques, including the erector spinae plane block (ESPB) and modified pectoral fascial…
- Conditions
- Congenital Heart Disease, Postoperative Pain After Cardiac Surgery Via Median Sternotomy, Anesthesia
- Trial name
- NCT07740915
- Testing
- Ultrasound-Guided Erector Spinae Plane Block, Ultrasound-Guided Modified Pectoral Fascial Plane Block
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Cardiac Surgery, Median Sternotomy
Early Rehabilitation in Patients Following Major Cardiac Surgery: Changes in Functional Capacity and Energy Efficiency in Walking and ADLs.
The main objective of this clinical trial is to evaluate exercise capacity before and after an inpatient or outpatient rehabilitation program in patients following major cardiac surgery.
- Trial name
- K5-POSTCCH (NCT07843316)
- Testing
- Use of COSMED K5, a portable metabolic system that allows real-time measurement of respiratory gas exchange, ventilation, and energy expenditure during physical activities.
- Where
- 3 sites in Italy
- Volunteers
- 60 people
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA
Postoperative Pain, Cardiac Surgery
ASPB-PIPB Combination in Cardiac Surgery
Cardiopulmonary bypass surgery is associated with significant postoperative pain, which may adversely affect respiratory function, delay mobilization, prolong hospital stay, and increase postoperative complications.
- Conditions
- Postoperative Pain, Cardiac Surgery, Cardiopulmonary Bypass, Median Sternotomy
- Trial name
- NCT07716943
- Testing
- Combined ASPB and PIPB, Anterior Serratus Plane Block
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
Pulmonary Dysfunction, Median Sternotomy Recovery
FROST-STERN Trial: A Trial of Intraoperative Cryoablation for Post Operative Pain Management After Full Sternotomy
Background and Rationale: Open-heart surgery via a median sternotomy is associated with severe acute postoperative pain. This pain can impair a patient's ability to take deep breaths and cough effectively which increases the risk…
- Conditions
- Pulmonary Dysfunction, Median Sternotomy Recovery, Postoperative Pain
- Trial name
- FROST-STERN (NCT07637370)
- Testing
- Intercostal Nerve Cryoablation
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Rutgers, The State University of New Jersey
Postoperative Pain, Cardiac Surgery
Parasternal Block Versus Wound Infiltration for Pain After Median Sternotomy:A Salivary Opiorphin-Based Study
This study evaluated the effects of parasternal block and wound site infiltration on postoperative pain in patients undergoing median sternotomy.
- Conditions
- Postoperative Pain, Cardiac Surgery, Median Sternotomy
- Trial name
- NCT07621744
- Testing
- Parasternal blocks, Wound Site Infiltration
- Where
- Turkey (Türkiye)
- Volunteers
- 120 people
- Sponsor
- Ataturk 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
Median Sternotomy, Pain Management
Effect of Parasternal Plane Block on Intraoperative Nociception
Effective pain control during pediatric cardiac surgery remains a major clinical challenge, particularly in procedures involving median sternotomy, which is associated with intense nociceptive stimulation.
- Trial name
- NCT07354750
- Testing
- Parasternal Plane Block, Group without peripheral nerve block
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people
- Sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
Sternal Instability After Median Sternotomy
Comparison of Supra-abdominal ex Versus Infra-abdominal With Laser on Median Sternotomy
the aim of this study is to find out the differences between the effect of supra- abdomen exercises and the effect of infra-abdomen exercise combined with LASER And the effect of LOW LEVEL LASER only on sternal instability.
- Trial name
- LLL/CABG (NCT07381387)
- Testing
- supra abdomen resisted exercises combined with LLL + Traditional cardiac rehabilitation program of phase one, ): patients will infra abdomen resisted exercises combined with LLL +Traditional cardiac rehabilitation program of phase one., patients will receive Traditional cardiac rehabilitation program of phase one with LLL
- Where
- Egypt
- Volunteers
- 120 people
- Sponsor
- Beni-Suef University
Postoperative Pain Management, Open-heart Surgery
Erector Spinae Plane Block and Postoperative Recovery After Open-Heart Surgery
This prospective randomized controlled clinical trial evaluated the effects of bilateral erector spinae plane block (ESPB) on postoperative systemic functions in adult patients undergoing elective open-heart surgery via median…
- Conditions
- Postoperative Pain Management, Open-heart Surgery, Median Sternotomy, Erector Spinae Plane Block
- Trial name
- ESPB-SYSHEART (NCT07259057)
- Testing
- Erector spinae plane block (ESPB), Intravenous Opioid Analgesia
- Where
- Turkey (Türkiye)
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Karadeniz Technical University
Median Sternotomy
RCT to Evaluate STERN FIX Device as a Sternal Stabilization System in Patients After Sternotomy
The goal of this clinical trial is to compare the safety and performance of the sternal stabilization system STERN FIX with the standard of care (sternal closure with wires only) in normal conditions of use, in patients of risk…
- Trial name
- FIXTER-2 (NCT05953259)
- Testing
- Combination of STERN FIX and wires, Wires
- Where
- 5 sites in Germany, Spain
- Volunteers
- 90 people
- Sponsor
- NEOS Surgery
Sternal Wound Complications, Obesity (Body Mass Index >30 kg/m2)
Sternal Closure in High-BMI Patients: Cable vs Wire
This retrospective study compares two sternal closure techniques-standard stainless-steel wires and rigid cable systems-in adult patients with a body mass index (BMI) ≥30 who underwent open-heart surgery between January 1, 2020…
- Conditions
- Sternal Wound Complications, Obesity (Body Mass Index >30 kg/m2), Median Sternotomy, Cardiac Surgery
- Trial name
- NCT07097272
- Where
- Turkey (Türkiye)
- Volunteers
- 110 people
- Sponsor
- Samsun University
Ultrasound, Pectoral Nerve Block
Ultrasound Guided Bilateral Pectoral Nerve Block Versus Bilateral Transverse Thoracic Plane Block In Pediatric Patients Undergoing Corrective Cardiac Surgeries Requiring Cardiopulmonary Bypass Via Median Sternotomy
This randomized, double-blinded, study aims to compare the efficacy of intraoperative and postoperative pain control while using bilateral ultrasound guided the pectoral nerves (PECS) versus transversus thoracic muscle plane…
- Conditions
- Ultrasound, Pectoral Nerve Block, Transverse Thoracic Plane Block, Pediatric Patients
- Trial name
- NCT06984276
- Testing
- Control, Pectoral nerves (PECS), Transversus thoracic muscle plane block (TTPB)
- Where
- Egypt
- Volunteers
- 81 people
- Sponsor
- Cairo University
Cardiac Surgery, Bone Wax, NU-KNIT, Median Sternotomy, Deep Sternal Wound Infection, Surgical Site Infection
Surgicel NU-KNIT Vs Bone Wax on Median Sternotomy
Bone wax is traditionally used as part of surgical procedures to prevent bleeding from exposed spongy bone. It is an effective hemostatic device which creates a physical barrier.
- Trial name
- NBCS (NCT06869772)
- Testing
- Closure of sternotomy
- Where
- Qatar
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Hamad Medical Corporation
Rigid Plate Fixation, Median Sternotomy
A Prospective, Single Center, Observational Study to Assess the Rapid Recovery After Cardiac Surgery Using SternaLock XP
The primary objective of this study is to evaluate the post-operative rapid recovery in patients treated with SternaLock XP for rigid sternal fixation with sternal precautions less restrictive than standard of care.
- Trial name
- RACE XP (NCT05578651)
- Testing
- SternaLock XP
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Zimmer Biomet
Median Sternotomy
Liposomal Bupivacaine and Bupivacaine for TTMPB in Median Sternotomy
In light of the ongoing controversy surrounding the efficacy of bupivacaine liposomes, our study was designed to investigate, for the first time, the differential postoperative analgesic effects between bupivacaine liposomes…
- Trial name
- NCT06646172
- Testing
- Transverse thoracic muscle plane block (TTMPB) using liposomal bupivacaine and bupivacaine mixture, Transverse thoracic muscle plane block (TTMPB) using bupivacaine hydrochloride
- Where
- China
- Volunteers
- 38 people
- Sponsor
- Tongji Hospital
Cadiac Surgery, Median Sternotomy
Analgesic Effect of Bilateral Erector Spinae Plane Block With Ropivacaine After Sternotomy for Cardiac Surgery
The sternotomy site is the most painful area after cardiac surgery. Erector spinae plane block is effective in thoracic and abdominal surgery, but literature is lacking in cardiac surgery.
- Conditions
- Cadiac Surgery, Median Sternotomy, Regional Anesthesia, Postoperative Pain
- Trial name
- ESB-Sterno (NCT05160298)
- Testing
- Ropivacaine 0,2% Injectable Solution, Control group
- Where
- France
- Volunteers
- 84 people
- Sponsor
- University Hospital, Clermont-Ferrand
Coronary Artery Bypass Grafting or Heart Valve Surgery Via Median Sternotomy
Transversus Thoracis Muscle Plane Block Plus Rectus Sheath Block in the Perioperative Pain Management of Cardiac Surgery
An emerging regional block technique, transverse thoracic muscle block covers the T2-T6 intercostal nerves and can effectively relieve perioperative pain during median sternotomy.
- Trial name
- NCT04838132
- Testing
- Bilateral transversus thoracis muscle plane and rectus sheath block with ropivacaine, Bilateral transversus thoracis muscle plane and rectus sheath puncture with saline
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Guangzhou First People's Hospital
Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy, Cardiopulmonary Bypass
Safety and Hemostatic Efficacy of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated (FS VH S/D) Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery
The objective of this study is to demonstrate equivalent hemostatic efficacy and safety between FS VH S/D and TISSEEL VH fibrin sealant in subjects undergoing cardiac surgery requiring cardiopulmonary bypass.
- Conditions
- Cardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy, Cardiopulmonary Bypass, Sternotomy
- Trial name
- NCT00161733
- Testing
- Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D), TISSEEL VH fibrin sealant
- Where
- 22 sites in United States
- Sponsor
- Baxter Healthcare Corporation
Coronary Artery Bypass Graft, Median Sternotomy
Risk Factors of Sternal Wound Infection After Coronary Artery Bypass Graft
The investigators are trying to evaluate the performance of neutrophil and lymphocyte counts as a risk factor of deep sternal wound infection after coronary artery bypass graft surgery.
- Trial name
- NCT01629030
- Where
- South Korea
- Volunteers
- 1,850 people
- Sponsor
- Samsung Medical Center
Median Sternotomy
Study to Evaluate the Safety and Efficacy of Dermal Injections of JVS-100 Given to Adults Receiving Median Sternotomy
This study will investigate the safety and efficacy of using JVS-100 to accelerate wound healing and reduce scar formation in subjects receiving surgical incisions ("sternotomies") during cardiovascular surgery.
- Trial name
- NCT01657045
- Where
- 6 sites in United States
- Volunteers
- 25 people
- Sponsor
- SironRX Therapeutics, Inc.