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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
71
Bilateral ultrasound-guided ESP(total of 60 ml, %0.25 bupivacaine) will be performed + IV morphine PCA Multimodal analgesia : Intraoperatively, all patients will receive 0.05 mg/kg (IBW) iv morphine. Thirty minutes before the end of surgery, 1 gram of intravenous paracetamol will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5mg/ml morphine. In cases where rescue analgesia is required (NRS score ≥4),iv fentanyl 25-50 mcg and/or ibuprofen and/or ketamine 10 mg will be administered. Patients are routinely administered iv dexamethasone 4 mg and IV 8 mg ondansetron 20 minutes before end of surgery for postoperative nausea and vomiting prophylaxis. Postoperative chronic pain will be assessed using the Brief Pain Inventory(BPI). Anxiety and depression status will be evaluated using the Hospital Anxiety and Depression Scale (HADS). The character of pain will be evaluated using the Douleur Neuropathique 4 (DN4) score.
IV PCA of 0,5mg/ml morphine (the bolus dose is 20 µg/kg, the lock-in time of 6-10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount).
Patients in this group will not be performed plane blocks. Multimodal analgesia : Intraoperatively, all patients will receive 0.05 mg/kg (IBW) iv morphine. Thirty minutes before the end of surgery, 1 gram of intravenous paracetamol will be administered. Postoperative analgesia: iv paracetamol 1gr every 8 hours and IV PCA of 0,5mg/ml morphine. In cases where rescue analgesia is required (NRS score ≥4),iv fentanyl 25-50 mcg and/or ibuprofen and/or ketamine 10 mg will be administered. Patients are routinely administered iv dexamethasone 4 mg and IV 8 mg ondansetron 20 minutes before end of surgery for postoperative nausea and vomiting prophylaxis. Postoperative chronic pain will be assessed using the Brief Pain Inventory(BPI). Anxiety and depression status will be evaluated using the Hospital Anxiety and Depression Scale (HADS) . The character of pain will be evaluated using the Douleur Neuropathique 4 (DN4) score.
V PCA of 0,5mg/ml morphine (the bolus dose is 20 µg/kg, the lock-in time of 6-10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount).
Ondokuz Mayis University
Samsun, Atakum, Turkey (Türkiye)
Chronic pain status
After patients are discharged, they will be contacted by phone at 3 months. Pain intensity and status will be assessed using the BPI, and the character of pain will be evaluated using the DN4 score.
Time frame: Postoperative 3rd month
Postoperative opioid consumption in the first 24 Hours
Morphine consumption in the first 24 hours will be measured. Patients will be able to request opioids via a PCA device when their NRS score ≥4
Time frame: Postoperative day 1
Postoperative pain scores
Pain at rest and while coughing will be assessed by numerical rating scale (NRS) scores at 0, 3, 6, 12, 18, and 24 hours after extubation. The NRS is an 11-point numeric scale that ranges from 0 to 10. The NRS is an 11-point scale consisting of integers from 0 to 10: 0 indicates "no pain" and 10 indicates "the worst pain ever possible." One day before the surgery, all patients will be informed about NRS and instructed on how to use a patient-controlled analgesia device.
Time frame: Postoperative day 1
The incidences of post-operative nausea and vomiting (PONV)
The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, 18, and 24 hours after extubation. If a score of 3 or more ondansetron 4 mg IV will be administered and will repeat after 8 hours if required.The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once.
Time frame: Postoperative day 1
The number of patient requiring rescue analgesic
The number of patients who required rescue analgesics will be recorded at 0, 3, 6, 12, 18, and 24 hours after extubation
Time frame: Postoperative day 1
Time to extubation
After the operation, the time until the patient is extubated will be recorded.
Time frame: Postoperative day 1
The number of patients with complications
The number of patients have any complications -directly related to the block or the drug used in the block- will be recorded.
Time frame: Postoperative 7 days on an average
Chronic pain status at 6 months.
After discharge, patients will be contacted by phone at 6 months. Pain intensity and status will be assessed using the Brief Pain Inventory, and the character of pain will be evaluated using the Douleur Neuropathique 4 (DN4) score. Additionally, the patient's anxiety and depression status will be assessed using the Hospital Anxiety and Depression Scale.
Time frame: Postoperative 6th month
Length of stay in the ICU
Total duration of stay in ICU will be recorded.
Time frame: The time from admission to the ICU to the time of discharge to the hospital ward; during the hospital stay, an average of 7 days
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