Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-26 @ 8:46 PM
Study NCT ID:
NCT06315959
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2024-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bilateral Erector Spinae Plane Block for Postoperative Chronic Pain After Open Heart Surgery
Sponsor:
Ondokuz Mayıs University
Organization:
Study Overview
Official Title:
Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Chronic Pain Following Open Heart Surgery: A Prospective Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed 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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: