Clinical trials: Cardiac Surgery With Sternotomy
Heart Surgery Via Sternotomy, Post-operative Analgesia
Advantage of Tramadol in Local Analgesia Post-Sternotomy
Sternotomy, the reference approach for heart surgery, may induce profound and intense post-operative pain. One method of analgesia used is patient-controlled intravenous morphine.
- Trial name
- ATLAS (NCT02851394)
- Testing
- Levobupivacaine, tramadol
- Where
- France
- Volunteers
- 160 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
Disruption or Dehiscence of Closure of Sternum or Sternotomy
Treatment With PTH After Sternotomy in Cardiac Surgery Patients
The aims of this study is to compare healing time and quality of newly formed bone in cardiac surgery patients treated with PTH post-surgically and a control group treated with saline.
- Trial name
- PAATH (NCT01466829)
- Testing
- Parathyroid hormone
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- University of Aarhus
Cardiac Surgery, Postoperative Pain
Erector Spinae Plane (ESP) Block With 20 ml Versus 30 ml in Cardiac Surgery
Even though erector spinae plane (ESP) block is shown to be efficient in cardiac surgery, it is still controversial how much volume is necessary for efficient analgesic effect for sternotomy and drain tube pain relief.
- Trial name
- NCT04928521
- Testing
- bilateral erector spinae plane block with 30 mL 0.25 % bupivacaine, bilateral erector spinae plane block with 20 mL 0.25 % bupivacaine
- Where
- Turkey (Türkiye)
- Volunteers
- 70 people
- Sponsor
- Ankara City Hospital Bilkent
Duration of Hospitalization in Intensive Care Unit
Evaluation of the Effectiveness of the Administration of Local Anesthetics Via Two Catheters Placed During Surgery, and Study of the Benefits on Respiratory Function and Therefore on Recovery Time
Currently intravenous analgesics are used for postoperative analgesia. But the analgesia of these products is tempered by their adverse effects (sedation, confusion, nausea or vomiting, delayed transit, urinary retention and…
- Trial name
- PARALSTER (NCT06463899)
- Testing
- multi-perforated catheter, Classic procedure
- Where
- France
- Volunteers
- 114 people
- Sponsor
- CHU de Reims
Advanced Refractory Left Ventricular Heart Failure
Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS
This is a prospective, post-market, multi-center, non-blinded, single arm study of the HeartMate 3 Left Ventricular Assist System (LVAS).
- Trial name
- SWIFT (NCT04548128)
- Testing
- HeartMate 3 Left Ventricular Assist System (HM3 LVAS)
- Where
- 32 sites in United States, Canada
- Volunteers
- 102 people
- Sponsor
- Abbott Medical Devices
Cardiac Surgical Procedures, Coronary Artery Disease
Clinical Outcomes in Patients Treated With SternaLock Blu
The primary objective of this study is to evaluate the rate of deep sternal wound infection at 30 days post-operative following a full median sternotomy in patients treated with SternaLock Blu for rigid sternal fixation.
- Conditions
- Cardiac Surgical Procedures, Coronary Artery Disease, Heart Valve Diseases
- Trial name
- SECURE (NCT03709693)
- Testing
- SternaLock Blu
- Where
- 4 sites in United States
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- Zimmer Biomet
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
A Study Comparing the Efficacy and Safety of Valdecoxib Plus Parecoxib Versus Valdecoxib Plus Placebo for the Treatment of Pain After Coronary Artery Bypass Surgery
The purpose of this study is to evaluate the efficacy and safety of parecoxib/valdecoxib therapy and placebo/valdecoxib therapy for the treatment of pain after coronary artery bypass surgery
- Trial name
- NCT00636064
- Testing
- Parecoxib Sodium/Valdecoxib
- Where
- 206 sites in United States, Argentina and 25 more
- Volunteers
- 1,671 people
- Sponsor
- Pfizer
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
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
Sternotomy, Postoperative Delirium
Comparison of the Postoperative Analgesic Effectiveness of Erector Spinae Plane Block Versus Its Combination With Superficial Parasternal Intercostal Plane Block Within the ERACS Program
This prospective, randomized, double-blind, parallel-group clinical trial within the Enhanced Recovery After Cardiac Surgery (ERACS) program compares postoperative analgesic effectiveness of bilateral erector spinae plane (ESP)…
- Conditions
- Sternotomy, Postoperative Delirium, Postoperative Pain Management
- Trial name
- ERACS-ESP-SPIP (NCT07304635)
- Testing
- Procedure: Erector Spinae Plane (ESP) Block, Erector Spinae Plane (ESP) Block + Superficial Parasternal Intercostal Plane (SPIP) Block
- Where
- Turkey (Türkiye)
- Volunteers
- 42 people
- Sponsor
- Ankara University
Coronary Atherosclerosis
Potential Effects of Omega 3 Supplementation on Cardiomyocytes Membranes for Patients With Coronary Atherosclerosis?
To show the existence of a atrial cardiomyocytes membranes modification in omega-3 supplemented patients with coronary atherosclerosis.
- Trial name
- CORONOMEGA3 (NCT01699230)
- Testing
- Omega 3
- Where
- France
- Volunteers
- 30 people
- Sponsor
- University Hospital, Clermont-Ferrand
Pain, Postoperative Pain
Presternal Bupivacaine Plus Magnesium Sulfate Infusion After Cardiac Surgery
Effective pain relief after cardiac surgery has assumed importance with the introduction of fast track discharge protocols that requires early weaning from mechanical ventilation.
- Trial name
- NCT02731950
- Testing
- Magnesium Sulfate and Bupivacaine 0.125%
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Assiut University
Coronary Artery Bypass Surgery
Exercise Tolerance in Patients With CABG and Sternotomy vs. Patients With Minimally Invasive Coronary Surgery
In this study, up to 20 healthy individuals, 20 endo-ACAB patients, and 20 CABG patients undergo a maximal cardiopulmonary exercise test after hospital discharge (for patients only). Exercise tolerance is compared between groups.
- Trial name
- ENDO-ACAB (NCT02433951)
- Testing
- Cardiopulmonary exercise test
- Where
- Belgium
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Hasselt University
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
Cardiac Surgery Subjects
Objective Measurement of the Mechanical Pain Threshold With an Algometer for Predicting Intraoperative Opioid Consumption in Patients Who Will be Operate by Thoracotomy and Sternotomy in Cardiac Surgery
The study aims to test the relationship between the preoperative pain threshold and the intraoperative need for opioids. The objective of the study is to try to predict a patient's analgesic needs based on their objectively…
- Trial name
- NCT07513974
- Testing
- Measure of the minimal pain threshold with an algometer
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- Université Libre de Bruxelles
Post Operative Pain
Comparison of PSB and RIFPB Combination With PSB and ESPB Combination in Cardiac Surgery With Sternotomy
The goal of this study is to compare the analgesic efficacy of the combination of PSB and RIFPB and the combination of PSB and ESPB in patients undergoing cardiac surgery with sternotomy.
- Trial name
- NCT06553573
- Testing
- Parasternal Block and Recto-İntercostal Fascial Plane Block, Parasternal Block and Erector Spinae Plane Block
- Volunteers
- 24 people
- Sponsor
- Cumhuriyet University
Postoperative Pulmonary Complications (PPCs), Cardiac Surgery With Sternotomy
Effect of Positioning and ACBT on Pulmonary Complications After Cardiac Surgery
The goal of this quasi-experimental clinical trial is to learn if position management combined with the Active Cycle of Breathing Techniques (ACBT) works to reduce postoperative pulmonary complications in adult patients…
- Conditions
- Postoperative Pulmonary Complications (PPCs), Cardiac Surgery With Sternotomy, Atelectasis, Postoperative Pneumonia
- Trial name
- P-ACBT (NCT07612033)
- Testing
- Structured Position Management Protocol, Active Cycle of Breathing Techniques (ACBT)
- Where
- Egypt
- Volunteers
- 124 people
- Sponsor
- Assiut University
Valvular Heart Disease
Effect of Trunk Stabilizing Exercises on Patients With Median Sternotomy After Heart Valve Surgery
PURPOSE: The aim of this study is to investigate the effect of trunk stabilizing exercises on sternal instability in patients with median sternotomy after heart valve surgery
- Trial name
- SIS (NCT04632914)
- Testing
- trunk stabilizing exercise, cardiac rehabilitation programe
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Cairo University
Acute Postoperative Pain
Intertransverse Process Block to Improve Quality of Recovery After Cardiac Surgery With Sternotomy
The goal of this clinical trial is to evaluate the efficacy of intertransverse process block (ITPB) in blunting sympathetic response of sternotomy, achieving perioperative opioid-sparing and improving quality of recovery in adult…
- Trial name
- NCT06926764
- Testing
- Intertransverse process block, Levobupivacaine 0.25%, Sodium Chloride (NaCl) 0.9 %
- Sponsor
- Chinese University of Hong Kong