Clinical trial NCT04906239: The Effect of Bilateral Erector Spina Plane Block on Postoperative Pain in Adult Cardiac Surgery.
Official title: The Effect of Bilateral Erector Spina Block on Postoperative Pain in Adult Cardiac Surgery: A Randomized, Clinical Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Opioid Use
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Morphine consumption by PCA (Patient Control Analgesia)
timeFrame: The change from baseline in the postoperative period 1, 4, 12 and 24 hours after extübation
Secondary outcomes:
measure: Pain (VAS Score)
timeFrame: Change From Baseline of VAS Score at 1, 4, 12 and 24 hours after being extubated will be recorded.
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaras Sutcu Imam University Faculty of Medicine
city: Kahramanmaraş
country: Turkey
facility: Yavuz Orak
Study officials:
affiliation: Kahramanmaraş Sütçü İmam Üniversitesi Tıp Fakültesi, Anesteziyoloji ve Reanimasyon Bölümü
name: Yavuz Orak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: