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Completed

NCT Number: NCT04906239

The Effect of Bilateral Erector Spina Plane Block on Postoperative Pain in Adult Cardiac Surgery.

Failure to adequately prevent pain after heart surgery increases morbidity and results in a high incidence of persistent poststernotomy pain syndrome. Aim in this study is to investigate analgesic consumption and postoperative pain effect in patients who underwent cardiopulmonary bypass with Erector Spinae Block, a new block.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kahramanmaras Sutcu Imam University Faculty of Medicine, Kahramanmaraş, Turkey (Türkiye)

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About this study

Failure to adequately prevent pain after heart 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 protection from pain in the lateral / posterior chest wall.

Ketamine and a2 agonists were used for intravenous analgesia to reduce opioid consumption. However, these drugs have potential side effects that limit their extensive clinical use as analgesic agents. The use of regional anesthetic techniques, e.g. thoracic epidural and thoracic paravertebral block, dural puncture, epidural hematoma, spinal cord injury, hypotension, pneumothorax, epidural abscess, ipsilateral Horner's syndrome Their use has declined due to the high failure rate of as much as 15% (especially for the thoracic epidural) and the significant possibility of complications.

Erector spinae (ESP) block, a new method, provides a wide multi dermatomal sensory block. In the T 4-5 spinous process, the bilateral ESP block provides analgesia from T2 to T9 sensory level and results in both somatic and visceral analgesia by blocking both the dorsal and ventral of the spinal nerves, including the sympathetic chain. This block can provide sufficient analgesia for the median sternotomy because the main nerve supply to the sternal region is from T2 to T6. Our aim in this study is to investigate analgesic consumption and postoperative pain effect in patients who underwent cardiopulmonary bypass with Erector Spina Block, a new block.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and / or female patients aged 18-65 will be included in the study.
  • Normal left ventricular function (alternating one, two and three vessels).
  • coronary artery patients scheduled for elective coronary artery surgery under cardiopulmonary bypass,
  • Valvular diseases planned for elective valve replacement with normal left ventricular function, ASD (Atrial Septal Defect) cases for atrial septal defect closure, and patients without left ventricular dysfunction (E / F≥ 50-55%) elective valve + CABG will be included in the study.

Exclusion criteria

  • Patients requiring acute coronary syndrome and emergency cardiovascular surgery,
  • Patients who have had myocardial infarction within the past month
  • Recurrent cardiovascular surgery
  • Off-pump coronary artery bypass surgery (OPCAB)
  • Patients with chronic inflammatory disease (rheumatoid arthritis, malignancy, psoriasis, etc.), autoimmune disease, immunocompromised patients
  • Patients with chronic renal failure, liver disease, active infection
  • Patients older than 80 years and smaller than 18 years
  • Patients with coagulation disorders

Treatment and study plan

Erector Spinae Plane Block

Procedure

A high-frequency ultrasound linear probe, covered with a sterile sheath, will be placed approximately 2 cm to the right or left of the T 4-5 spinous process. After showing the T 4-5 transverse process and the erector spinae muscle on top of it, a 22-gauge, 80 mm insulated quincke type needle will be inserted into the skin at an angle of approximately 30 degrees from cranial to caudal, using the in-plane technique. When the transverse process is touched, the needle will be pulled out and after a negative aspiration test with 0.5 mL of normal saline and after the demonstration of a hypo-echogenic image and hydro dissection, a local anesthetic solution will be applied to the fascia beneath the erector spinae muscle. A 20 mL dose of 0.25% bupivacaine, which has been shown to spread both above and below the T 4-5 level, will be injected.

Primary outcomes

  1. Morphine consumption by PCA (Patient Control Analgesia)

    Time frame: The change from baseline in the postoperative period 1, 4, 12 and 24 hours after extübation

    Morphine consumption used in case of pain

Secondary outcomes

  1. Pain (VAS Score)

    Time frame: Change From Baseline of VAS Score at 1, 4, 12 and 24 hours after being extubated will be recorded.

    Change from Baseline VAS Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

The Effect of Bilateral Erector Spina Block on Postoperative Pain in Adult Cardiac Surgery: A Randomized, Clinical Study.

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 28, 2021
Registry last updated
Apr 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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