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

Not Applicable

Completed

• Conditions: Postoperative Pain; Opioid Use
• Interventions: Procedure: Erector Spinae Plane Block

• Registration Number: NCT04906239
• Lead Sponsor: Kahramanmaras Sutcu Imam University

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.

Study Timeline

• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-28
• Study Start: 2021-06-01
• Primary Completion: 2022-02-15
• Study Completion: 2022-03-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group ESP	Erector Spinae Plane Block	While the patient is in a sitting position, A ultrasound 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 the T 4-5 transverse process and the erector spinae muscle above it are shown, a quincke-type needle will be inserted into the skin at an angle of approximately 30 degrees from cranial to caudal with the entrance made using the in-plane technique. When the transverse process is touched, the needle will be pulled out and 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.The same procedure will be repeated on the contralateral side of the T5 spinous process and half of the remaining bupivacaine dose will be injected. The total volume of bupivacaine injected on both sides will be 20 mL.

Primary Outcome Measures

Name	Time	Method
Morphine consumption by PCA (Patient Control Analgesia)	The change from baseline in the postoperative period 1, 4, 12 and 24 hours after extübation	Morphine consumption used in case of pain

Secondary Outcome Measures

Name	Time	Method
Pain (VAS Score)	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

Trial Locations

Locations (2)

Kahramanmaras Sutcu Imam University Faculty of Medicine; 🇹🇷 Kahramanmaraş, Turkey

Yavuz Orak; 🇹🇷 Kahramanmaraş, Turkey