Clinical trials: Sternotomy
Post Operative Pain
Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT
The purpose of this prospective randomized controlled trial is to compare the effectiveness of two different delivery methods for postoperative pain management following cardiac surgery requiring median sternotomy: intermittent…
- Trial name
- NCT05642416
- Testing
- Continuous Infusion of ropivacaine, Intermittent bolus of ropivacaine
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Henry Ford Health System
Surgical Site Occurences After Sternotomy, Wound Infection
The Use of PrevenaTM on Clean Closed Sternal Midline Incisions in Subjects at High Risk for Surgical Site Occurrences.
The purpose of this study is to compare the use of Prevena™ Incision Management System (IMS) versus standard wound care for the incision in subjects undergoing a sternal midline incision (sternotomy).
- Trial name
- NCT02195310
- Testing
- Prevena™ Incision Management System, Conventional sterile wound dressings
- Where
- 13 sites in Austria, Germany and 1 more
- Volunteers
- 342 people
- Sponsor
- Solventum US LLC
Coronary Artery Disease, Coronary Artery Stenoses
Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride
The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) and compare it…
- Conditions
- Coronary Artery Disease, Coronary Artery Stenoses, Valve Regurgitation, Mitral, Valve Regurgitation, Tricuspid
- Trial name
- NCT03270514
- Testing
- Exparel Injectable Product, Bupivacaine Hydrochloride
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Kathirvel Subramaniam
Sternal Wound Infection, Sternal Non-union
Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain
The goal of this study is to evaluate sternal osteosynthesis, chest wall pain and return to normal activity in open heart surgery patients who had their breast bone closed either with wires or plates.
- Conditions
- Sternal Wound Infection, Sternal Non-union, Pain, Mediastinitis
- Trial name
- RESTORE (NCT00819286)
- Testing
- SternaLock Rigid Fixation Plates, wire (control)
- Where
- 6 sites in United States, Germany
- Volunteers
- 140 people
- Sponsor
- Zimmer Biomet
Coronary Artery Disease, Sternal Pain
Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery
The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to…
- Trial name
- NCT03482973
- Testing
- Bupivacaine Group
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Beth Israel Deaconess Medical Center
Postoperative Pain
Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management
To evaluate the efficacy of bilateral continuous erector spinae blocks (BESB) for postoperative analgesia in children and adolescents undergoing cardiac surgical procedures via sternotomy in the Early Recovery After Surgery…
- Trial name
- NCT04567407
- Testing
- Bilateral erector spinae blocks using ropivacaine
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Pain, Postoperative
Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management: A Pilot Study
Overall Aim: To evaluate the feasibility and potential benefits of investigating bilateral continuous erector spinae blocks (BESB) for postoperative pain management in a small cohort of children undergoing surgical sternotomy…
- Trial name
- NCT03936387
- Testing
- Ropivacaine
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Analgesia, Sternotomy
Pecto-intercostal Fascial Block (PIFB) for Postop Analgesia Following Sternotomy in Cardiac Surgery Patients
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…
- Trial name
- NCT05676814
- Testing
- Pecto-intercostal Fascial Block (PIFB), PIFB with adjuvants
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Wake Forest University Health Sciences
Postoperative Pain
PAIN - Postoperative Analgesia INvestigation
The purpose of this study is to assess the efficacy of the intraoperative injection of prolonged acting (liposomal) bupivacaine in postoperative pain control after truncal surgical incisions.
- Trial name
- PAIN (NCT02111746)
- Testing
- Exparel, Bupivacaine hydrochloride, Patient Controlled Analgesia (PCA)
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- The University of Texas Health Science Center, Houston
Right Ventricular Dysfunction
TEE 3D RV Assessment for SAVR, Mini AVR, and TAVR
Three-dimensional echocardiography has become a gold standard to assess right ventricular (RV) function, and investigators plan to use 3D transesophageal echocardiography to assess RV function in 3 types of aortic valve…
- Trial name
- NCT05804240
- Testing
- 3D TEE RVEF
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- Thomas Jefferson University
Surgical Site Infection, Sternal Infection
D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
Prospective, Multinational, Multicenter, Randomized, Parallel Controlled, Two arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SOC) IV Prophylactic…
- Conditions
- Surgical Site Infection, Sternal Infection, Cardiac Surgery
- Trial name
- NCT03558984
- Testing
- D-PLEX, Standard of Care
- Where
- 3 sites in United States, Israel
- Volunteers
- 2 people
- Sponsor
- PolyPid Ltd.
Pain
Pain Control After Cardiac Surgery Using Intravenous Acetaminophen
Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption and/or pain intensity scores after cardiac surgery.
- Trial name
- NCT01822821
- Testing
- IV Acetaminophen
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- The Cleveland Clinic
Aortic Valve Disease, Aortic Stenosis
EDWARDS INTUITY Valve System CADENCE-MIS Study
The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.
- Trial name
- CADENCE-MIS (NCT02672553)
- Testing
- EDWARDS INTUITY Valve System, Model 8300A, Stented Aortic Bioprostheses
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Coronary Artery Disease, Angina Pectoris
An Evaluation of Rigid Sternal Fixation in Supporting Bone Healing and Improving Postoperative Recovery
The primary objective of this study is to evaluate sternal bone healing following a full median sternotomy versus standard of care for sternal closure with wire cerclage.
- Conditions
- Coronary Artery Disease, Angina Pectoris, Cardiac Valve Disease
- Trial name
- SB (NCT01783483)
- Testing
- SternaLock Blue closure system, Suture Wire
- Where
- 12 sites in United States
- Volunteers
- 236 people
- Sponsor
- Zimmer Biomet