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Bilateral Erector Spina Block Versus Parasternal Block in Adult Heart Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04090099
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
Yavuz Orak, Kahramanmaras Sutcu Imam University

Brief Summary:
Inadequate pain relief after cardiac surgery increases morbidity and results in a high incidence of persistent poststernotomy pain syndrome. The use of special opioid-based analgesia causes adverse effects such as nausea, vomiting, sedation, urinary retention, respiratory depression and delayed tracheal extubation. Regional anesthesia techniques such as pectoralis nerve block and serratus anterior block provide analgesia in the sternum and pain relief in the lateral / posterior chest Wall. Erector spinae (ESP) block, a new and simple myofascial block, provides wide multi-dermatomal sensory block. In the T5 spinous process, bilateral ESP block provides analgesia from T2 to T9 sensory level, resulting in both somatic and visceral analgesia by blocking both the dorsal and ventral of the spinal nerves, including the sympathetic chain. This block may provide adequate analgesia for median sternotomy because the main nerve supply to the sternal region is from T2 to T6. Median sternotomy incision and mediastinal tube regions are the major source of pain in patients undergoing cardiac surgery. The anterior and posterior branches of the intercostal nerves give nerves to the sternum. Parasternal local anesthetic infiltration around the sternum is effective in providing early postoperative analgesia and reducing opioid requirements and therefore has positive effects on healing. This simple and fast technique can be used even for anticoagulated patients.

Condition or disease Intervention/treatment Phase
Morphine Consumption Pain, Postoperative Other: Erector spina plane block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Ultrasound-GTrialuided Bilateral Erector Spina Block Versus Parasternal Block in Adult Cardiac Surgery: A Prospective, Randomized, Controlled Study.
Actual Study Start Date : September 17, 2019
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
No Intervention: Group C
PCA (Patient controlled analgesia) and morphine consumption will be monitored in the postoperative period.
Active Comparator: Group ES (Erector Spina Plane)
A high frequency (10-18 MHz) ultrasound linear probe covered with a sterile sheath will be placed 2 cm to the side of the T5 spinous process, first to the right or left. After demonstrating the T5 transverse process and the erector spinae muscle on top, the 22-gauge, 80 mm insulated Quincke-type needle will be inserted into the skin at an angle of about 30 degrees from the cranial to the caudal, using an in-plane technique. When the transverse process is touched, the needle is withdrawn and after a negative aspiration test with 0.5 mL of normal saline and after a hypo-echogenic display and hydrodissection, a local anesthetic solution will be applied to the fascia under the erector spinae muscle. A dose of 0.25% bupivacaine will be injected which is shown to spread both above and below the T5 level. The same process will be implemented on the other side.
Other: Erector spina plane block
While the patient is in the sitting position, an area containing 2 cm lateral of the T5 spinous process will be cleaned with povidone iodine. A high frequency ultrasound linear probe covered with a sterile sheath will be placed 2 cm to the side of the T5 spinous process, first to the right or left. After demonstrating the T5 transverse process and the erector spinae muscle on top, the 22-gauge, 80 mm insulated Quincke-type needle will be inserted into the skin at an angle of about 30 degrees from the cranial to the caudal, using an in-plane technique. When the transverse process is touched, the needle is withdrawn and after a negative aspiration test with 0.5 mL of normal saline and after a hypo-echogenic display and hydrodissection, a local anesthetic solution will be applied to the fascia under the erector spinae muscle.

Active Comparator: Group PS (Para Sternal Block)
Before the wire is inserted into the sternum, the sternotomy and mediastinal tube regions will be infiltrated with a mixture of bupivacaine and saline.
Other: Erector spina plane block
While the patient is in the sitting position, an area containing 2 cm lateral of the T5 spinous process will be cleaned with povidone iodine. A high frequency ultrasound linear probe covered with a sterile sheath will be placed 2 cm to the side of the T5 spinous process, first to the right or left. After demonstrating the T5 transverse process and the erector spinae muscle on top, the 22-gauge, 80 mm insulated Quincke-type needle will be inserted into the skin at an angle of about 30 degrees from the cranial to the caudal, using an in-plane technique. When the transverse process is touched, the needle is withdrawn and after a negative aspiration test with 0.5 mL of normal saline and after a hypo-echogenic display and hydrodissection, a local anesthetic solution will be applied to the fascia under the erector spinae muscle.




Primary Outcome Measures :
  1. Morphine consumption by PCA [ Time Frame: Change from baseline 1 , 3, 6, 12 and 24 hours after extubation ]
    Morphine consumption used in case of pain


Secondary Outcome Measures :
  1. Change Pain Scores [ Time Frame: Time Frame: 1 hour,3 hours, 6 hours, 12 hours, 24 hours after the extubation ]
    NRS (Numeric Rating scale) Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated

  2. Change Blood Gas [ Time Frame: Change from Baseline at 60 minutes,2 hours, 4 hours, 6 hours, 12 hours, 24 hours after Operation , ]
    PH, PO2

  3. Blood Pressure [ Time Frame: Change from Baseline at 60 minutes,2 hours, 4 hours, 6 hours, 12 hours, 24 hours after Operation , ]
    mean arterial pressure mmHg



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and / or female patients
  • Aged 18-65 years
  • Patients who will have coronary artery surgery under cardiopulmonary baypass (changing one, two and three vessels) with normal left ventricular function,
  • Valve diseases with normal left ventricular function,
  • ASD (Atrial Septal Defect) cases for atrial septal defect closure
  • Patients with valve + CABG without left ventricular dysfunction will be included in the study.
  • Ejection- Fraction> 50-55

Exclusion Criteria:

  • Emergency and repeat heart surgery cases
  • Advanced left coronary artery disease and left ventricular dysfunction
  • Receiving preoperative inotropic support therapy,
  • With mitral stenosis with atrial tombus,
  • With low cardiac out put syndrome,
  • Need intra-aortic balloon pump during surgery,
  • Bleeding and coagulation disorder,
  • Liver and kidney dysfunction,
  • Patients with uncontrolled diabetes mellitus and coronary artery pulmonary disease,
  • Opioid, analgesic and bupivacaine allergy,
  • Patients with atrial fbrilation using anticoagulants
  • Patients with cognitive dysfunction
  • Patients who do not want to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090099


Contacts
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Contact: yavuz orak, md +90344 300 3434 ext 3343 dryavuzorak@hotmail.com

Locations
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Turkey
Kahramanmaras Sutcu Imam Univercity Faculty of edicine Recruiting
Kahramanmaraş, Onikişubat, Turkey, 251/A 46040
Contact: Yavuz Orak, md    +90 (344) 300 3434 ext 3343    dryavuzorak@hotmail.com   
Kahramanmaras Sutcu Imam University Faculty of Medicine Recruiting
Kahramanmaraş, Onikişubat, Turkey, 251/A 46040
Contact: Yavuz Orak, md    +90 (344) 300 3434 ext 3343    dryavuzorak@hotmail.com   
Sponsors and Collaborators
Kahramanmaras Sutcu Imam University
Investigators
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Principal Investigator: yavuz orak, md Kahramanmaraş Sutcu Imam University Faculty of Medicine
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Responsible Party: Yavuz Orak, Assistant Professor, Kahramanmaras Sutcu Imam University
ClinicalTrials.gov Identifier: NCT04090099    
Other Study ID Numbers: 2019/14-08
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yavuz Orak, Kahramanmaras Sutcu Imam University:
Erector Spinae Block, Parasternal block, Cardiac surgery
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms