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Clinical Trials/NCT04906239
NCT04906239
Completed
N/A

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

Kahramanmaras Sutcu Imam University2 sites in 1 country40 target enrollmentJune 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Kahramanmaras Sutcu Imam University
Enrollment
40
Locations
2
Primary Endpoint
Morphine consumption by PCA (Patient Control Analgesia)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
March 15, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kahramanmaras Sutcu Imam University
Responsible Party
Principal Investigator
Principal Investigator

Yavuz Orak

Assistant Professor

Kahramanmaras Sutcu Imam University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Pain (VAS Score)(Change From Baseline of VAS Score at 1, 4, 12 and 24 hours after being extubated will be recorded.)

Study Sites (2)

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