Clinical trial NCT04591119: Transversus Thoracis Muscle Plane Block for Postoperative Pain in Adult Cardiac Surgery
Official title: Bilateral Transversus Thoracis Muscle Plane Block for Acute Postoperative Pain in Adult Coronary Artery Bypass Graft Surgery: A Randomized Controlled Observer Blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Chest Pain
Coronary Artery Bypass
Sternotomy
Keywords: adult cardiac surgery
poststernotomy pain
transversus thoracic muscle plane block
parasternal intercostal block
behavioral pain scale
numeric rating scale
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 75
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Inadequate pain control after coronary artery bypass graft surgery increases mortality and results in a higher incidence of persistent poststernotomy pain syndrome. Our aim is to assess whether ultrasound-guided parasternal intercostal block (PSIB) or surgeon implied transversus thoracic muscle plane block (TTMPB) would improve the postoperative pain scores and decrease tramadol consumption better after coronary artery bypass graft surgery


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status II-III
* Elective coronary artery bypass graft surgery under general anesthesia

Exclusion Criteria:

* American Society of Anesthesiologists physical status IV
* Emergency surgery and redo surgery
* Low cardiac output syndrome, perioperative intra-aortic balloon pump support for any reason, bleeding disorder or abnormal coagulation profile, abnormal hepatic and renal parameters, uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, atrial fibrillation on anticoagulation
* Allergy to any study drugs, local infection at the block site
* Opioid abuse

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: Postoperative 24th hour
measure: Postoperative opioid consumption
timeFrame: Postoperative 1st, 4th and 12th hour
Secondary outcomes:
measure: Behavioral Pain Scale
timeFrame: postoperative 1st and 4th hour
measure: Numeric Rating Scale
timeFrame: Postoperative 12th and 24th hour
Other outcomes:
Locations:
city: Mugla
country: Turkey
facility: Mugla Sıtkı Kocman University Training nad research Hospital
Study officials:
affiliation: Mugla Sıtkı Kocman University Department of Anesthesiology and Reanimation
name: Melike Korkmaz Toker, Assist.Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ueshima H, Takeda Y, Ishikawa S, Otake H. RETRACTED: Ultrasound-guided transversus thoracic muscle plane block: a cadaveric study of the spread of injectate. J Clin Anesth. 2015 Dec;27(8):696. doi: 10.1016/j.jclinane.2015.05.013. Epub 2015 Jul 3. No abstract available.
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.