Clinical trial NCT06315959: Bilateral Erector Spinae Plane Block for Postoperative Chronic Pain After Open Heart Surgery
Official title: Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Chronic Pain Following Open Heart Surgery: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Cardiac Surgery
Post Operative Pain
Keywords: Chronic Pain
Cardiac surgery
Erector Spinae Plane Block
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer (Urbaniak and Plous, 2013)'.
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Chronic pain status
timeFrame: Postoperative 3rd month
Secondary outcomes:
measure: Postoperative opioid consumption in the first 24 Hours
timeFrame: Postoperative day 1
measure: Postoperative pain scores
timeFrame: Postoperative day 1
measure: The incidences of post-operative nausea and vomiting (PONV)
timeFrame: Postoperative day 1
measure: The number of patient requiring rescue analgesic
timeFrame: Postoperative day 1
measure: Time to extubation
timeFrame: Postoperative day 1
measure: The number of patients with complications
timeFrame: Postoperative 7 days on an average
measure: Chronic pain status at 6 months.
timeFrame: Postoperative 6th month
measure: Length of stay in the ICU
timeFrame: 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
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
state: Atakum
Study officials:
affiliation: : Ondokuz Mayis Universitesi, Samsun, Atakum 55139
name: Burhan Dost
role: STUDY_DIRECTOR
References: