Bilateral Erector Spinae Plane Block for Postoperative Chronic Pain After Open Heart Surgery

Ondokuz Mayıs University

Status: Completed

Conditions: Cardiac Surgery; Chronic Pain; Post Operative Pain

Treatments: Procedure: Bilateral ultrasound guided erector spinae plane block; Drug: morphine PCA; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT06315959

ESPCHRONIC2023

Details and patient eligibility

About

The aim of this study is to investigate the effect of bilateral erector spinae plane (ESP) block application on postoperative chronic pain in patients undergoing on-pump open-heart surgery. At 3 months post-discharge, patients will be contacted by phone to assess their chronic pain status. Pain intensity and status will be evaluated using the Brief Pain Inventory, and the character of pain will be assessed using the Douleur Neuropathique 4 (DN4) score. Additionally, the patient's anxiety and depression status will be evaluated using the Hospital Anxiety and Depression Scale.

Full description

Acute or chronic pain following cardiac surgery is a common issue that significantly impacts quality of life. The reported incidence of moderate to severe acute pain post-cardiac surgery varies widely in the literature, ranging from less than 5% to over 80%. Factors contributing to severe postoperative pain after median sternotomy include vasospasm, increased inflammatory response, soft tissue and bone injury during dissection, and chest tube placement. While pain typically decreases after the first 24 hours post-surgery, inadequate pain management can prolong this period. Chronic pain syndrome following sternotomy has been reported in 7% to 66% of patients undergoing open-heart surgery.

Initially, neuraxial anesthesia techniques such as thoracic epidural or thoracic paravertebral blocks were recommended for postoperative pain control in minimally invasive cardiac surgery. However, debates exist due to technical and patient-related challenges such as procedural difficulties, coagulation disorders, complete heparinization, hemodynamic instability, and pneumothorax. Fascial plane chest wall blocks involving serratus anterior and erector spinae have gained popularity for managing postoperative pain after minimally invasive cardiac surgery and thoracotomy/sternotomy, especially in patients receiving antiplatelet and anticoagulant therapy. An alternative approach, ultrasound-guided erector spinae plane block (ESPB), was introduced by Forero and colleagues in 2016 for treating thoracic neuropathic pain.

Inadequate pain control post-surgery can lead to persistent postoperative pain, high opioid consumption, and opioid-related morbidity. Theoretically, in patients receiving an erector spinae plane (ESP) block, the local anesthetic spreads both cranio-caudally and anteriorly through the costotransverse foramina, blocking the ventral/dorsal branches of spinal nerves, dorsal root ganglion, and rami communicantes at multiple levels. In patients undergoing sternotomy for cardiac surgery, bilateral thoracic ESP catheters or a single injection technique have reduced opioid use and pain scores.

This study is planned as a prospective, randomized controlled, double-blind, parallel-group trial.

Patients will be divided into two groups:

ESP Group: General anesthesia + ESP Block + Patient-Controlled Analgesia (PCA) Group K: General anesthesia + PCA

Enrollment: 71 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18-80 undergoing elective on-pump open-heart surgery via median sternotomy.
• American Society of Anesthesiologists (ASA)classification II-III patients.
• Patients who can use PCA.
• Patients who will sign the informed consent form.

Exclusion criteria

• History of opioid use for more than four weeks
• Chronic pain syndromes
• Patients with a history of local anesthetic or opioid allergy, hypersensitivity
• Alcohol and drug addiction
• Conditions where regional anesthesia is contraindicated
• Failure in the dermatomal examination performed after the block
• Emergency surgeries and redo surgeries.
• Individuals with obstructive sleep apnea.
• Left ventricular ejection fraction less than 30%.
• Patients with severe psychiatric illnesses (such as psychosis, dementia) that limit cooperation with verbal numerical pain scales.
• Pregnant and breastfeeding patients.
• Hematological disorders.
• Significant impairment in the function of a major organ (e.g., severe hepatic or renal disease).
• Patients who cannot be extubated within the first 6 hours postoperatively.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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71 participants in 2 patient groups

Group ESP

Active Comparator group

Description:

A bilateral ESP Block(60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA)

Treatment:

Drug: morphine PCA

Drug: morphine PCA

Procedure: Bilateral ultrasound guided erector spinae plane block

Group Control

Other group

Description:

IV morphine PCA

Treatment:

Drug: morphine PCA

Other: Control group

Drug: morphine PCA