Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06315959
Study type Interventional
Source Ondokuz Mayis University
Contact Burhan DOST, Assoc.Prof
Phone +903623121919
Email burhandost@hotmail.com
Status Recruiting
Phase N/A
Start date April 1, 2024
Completion date March 15, 2025

See also
  Status Clinical Trial Phase
Completed NCT01659073 - Using Perfusion MRI to Measure the Dynamic Changes in Neural Activation Associated With Caloric Vestibular Stimulation N/A
Recruiting NCT05914311 - Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration N/A
Recruiting NCT05422456 - The Turkish Version of Functional Disability Inventory
Enrolling by invitation NCT05422443 - The Turkish Version of Pain Coping Questionnaire
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04385030 - Neurostimulation and Mirror Therapy in Traumatic Brachial Plexus Injury N/A
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05103319 - Simultaneous Application of Ketamine and Lidocaine During an Ambulatory Infusion Therapy as a Treatment Option in Refractory Chronic Pain Conditions
Completed NCT03687762 - Back on Track to Healthy Living Study N/A
Completed NCT04171336 - Animal-assisted Therapy for Children and Adolescents With Chronic Pain N/A
Completed NCT03179475 - Targin® for Chronic Pain Management in Patients With Spinal Cord Injury Phase 4
Completed NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Completed NCT03268551 - MEMO-Medical Marijuana and Opioids Study
Recruiting NCT06060028 - The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain N/A
Recruiting NCT06204627 - TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain N/A
Completed NCT05496205 - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers Phase 1
Completed NCT00983385 - Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics Phase 3
Recruiting NCT05118204 - Randomized Trial of Buprenorphine Microdose Inductions During Hospitalization Phase 4
Terminated NCT03538444 - Repetitive Transcranial Magnetic Stimulation for Opiate Use Disorder N/A
Not yet recruiting NCT05812703 - Biometrics and Self-reported Health Changes in Adults Receiving Behavioral Treatments for Chronic Pain