Clinical trial NCT05191953: ESPB vs.Combination of ESPB and Superficial PIPB in Cardiac Surgery
Official title: Erector Spinae Plane Block Versus Its Combination With Superficial Parasternal Intercostal Plane Block for Postoperative Pain After Cardiac Surgery: A Prospective, Randomized, Double-blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Analgesia
Acute Pain
Patient Controlled Analgesia
Keywords: Regional Anesthesia
Acute Pain Scores
Morphine Consumption
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2022-01-14
Enrollment: 48
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: SUPPORTIVE_CARE

Brief summary: Cardiac surgery is associated with significant postoperative pain. Pain control is an essential part of enhanced recovery protocols. The aim of this study is to evaluate and compare the analgesic efficacies of erector spinae plane block (ESPB) and the combination of ESPB and superficial parasternal intercostal plane block (PIPB) in patients undergoing elective cardiac surgery.

Detailed description: Many regional techniques have been used to manage postoperative pain in cardiac surgery, including thoracic epidural anesthesia, paravertebral, intercostal nerve block, intrathecal spinal morphine, and local infiltration. Increased risk of epidural/spinal hematoma secondary to systemic heparinization, potential hemodynamic instability, technical difficulties and complications such as pneumothorax are potential serious drawbacks. Due to the aforementioned reasons, anesthetists are understandably preferring ultrasound (US) guided interfascial plane blocks, which are generally thought to provide safer and more effective analgesia in cardiac surgery.

This study aims to evaluate and compare the effects of ESPB versus ESPB plus Superficial PIPB on pain scores and opioid consumption in patients undergoing elective cardiac surgery.

Patients will be divided into two groups:

Group ESPB:

In this group, patients will be administered bilateral ESPB (total of 40 ml, %0.25 bupivacaine) in addition to IV morphine patient-controlled analgesia (PCA) for the first 24 postoperative hours.

Group ESPB+Superficial PIPB:

In this group, patients will be administered Bilateral ESPB (total of 40 ml, %0.25 bupivacaine) and bilateral Superficial PIPB (total of 20 ml, %0.25 bupivacaine). In addition, IV morphine PCA will be administered for the first 24 postoperative hours.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) 2-3 patients between the ages of 18-80 who are scheduled for elective cardiac surgery (coronary artery bypass graft surgery +/- valve replacement or isolated valve surgery)
* BMI \<35 kg / m2

Exclusion Criteria:

* Emergent surgeries, redo cases, minimally invasive procedures
* Patients who do not want to participate
* Patients with cognitive dysfunction (patients who are not able to evaluate the verbal numerical pain scale)
* Hypersensitivity or history of allergies to local anesthetics
* Major liver or kidney dysfunction or other pre-existing major organ dysfunction
* Left ventricular ejection fraction \<30
* Individuals with mental health disorders (for example bipolar disorder or depression)
* Pregnancy or breastfeeding
* Presence of hematological disease
* Patients with alcohol-drug addiction

Primary outcomes:
measure: Morphine consumption in the first 24 hours after surgery
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Postoperative pain scores
timeFrame: Postoperative day 1
measure: Time to extubation
timeFrame: Postoperative day 1
measure: The number of patient requiring rescue analgesic
timeFrame: Postoperative Day 1
measure: The incidences of post-operative nausea and vomiting (PONV)
timeFrame: Postoperative Day 1
measure: Patient satisfaction as measured by the Revised American Pain Society Patient Outcome Questionnaire
timeFrame: Postoperative Day 1
measure: The number of patients with complications
timeFrame: Postoperative 7 days on an average
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
state: Atakum
Study officials:
affiliation: Ondokuz Mayıs University Faculty of Medicine
name: BURHAN DOST
role: STUDY_DIRECTOR
References:
citation: Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
citation: Khera T, Murugappan KR, Leibowitz A, Bareli N, Shankar P, Gilleland S, Wilson K, Oren-Grinberg A, Novack V, Venkatachalam S, Rangasamy V, Subramaniam B. Ultrasound-Guided Pecto-Intercostal Fascial Block for Postoperative Pain Management in Cardiac Surgery: A Prospective, Randomized, Placebo-Controlled Trial. J Cardiothorac Vasc Anesth. 2021 Mar;35(3):896-903. doi: 10.1053/j.jvca.2020.07.058. Epub 2020 Jul 24.
citation: Aydin ME, Ahiskalioglu A, Ates I, Tor IH, Borulu F, Erguney OD, Celik M, Dogan N. Efficacy of Ultrasound-Guided Transversus Thoracic Muscle Plane Block on Postoperative Opioid Consumption After Cardiac Surgery: A Prospective, Randomized, Double-Blind Study. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):2996-3003. doi: 10.1053/j.jvca.2020.06.044. Epub 2020 Jun 18.
citation: de la Torre PA, Garcia PD, Alvarez SL, Miguel FJ, Perez MF. A novel ultrasound-guided block: a promising alternative for breast analgesia. Aesthet Surg J. 2014 Jan 1;34(1):198-200. doi: 10.1177/1090820X13515902. No abstract available.
citation: Dost B, Kaya C, Turunc E, Dokmeci H, Yucel SM, Karakaya D. Erector spinae plane block versus its combination with superficial parasternal intercostal plane block for postoperative pain after cardiac surgery: a prospective, randomized, double-blind study. BMC Anesthesiol. 2022 Sep 16;22(1):295. doi: 10.1186/s12871-022-01832-0.