Clinical trial NCT06601530: Effect of Transversus Thoracic Muscle Plane Block (TTMP) on Analgesia
Official title: Investigation of the Efficacy of Transversus Thoracic Muscle Plane Block in Patients Undergoing Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Bypass
Anesthesia, Conduction
Nerve Block
Pain, Postoperative
Keywords: Transversus thoracic muscle plane block, postopertive pain, sternotomy
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this prospective and controlled study, the investigators investigated the effect of transversus thoracic muscle plane block (TTMP) on analgesia in patients who undergo coronary artery bypass graft (CABG) surgery with median sternotomy. For this purpose, the investigators aimed to compare the hemodynamic responses to surgical incision and sternotomy and, pain intensity, total analgesic consumption, additional analgesic requirements of the patients in the first 24 hours after extubation under postoperative patient-controlled analgesia (PCA) adminisration.

Detailed description: Forty-six patients aged 18-70 years, ASA class I-III, who undergo CABG surgery were included in our study. The patients were randomized into the TTKPB group and the control group. Heart rate (HR) and mean arterial pressure (MAP) were recorded before peroperative induction, before skin incision, after skin incision, before sternotomy and after sternotomy. PCA with tramadol was applied after extubation and "Numeric rating scale" NRS scores, total tramadol consumption, number of requests and additional analgesic requirements were recorded at 0, 1, 2, 4, 8, 12 and 24 hours.

Eligibility criteria: Inclusion Criteria:

* ASA (American Society of Anesthesiologists) classification I-III
* Coronary artery bypass graft operation with median sternotomy under elective conditions

Exclusion Criteria:

* Refusing to participate in the study
* Under 18 and over 70
* ASA class IV and above
* EF (Ejection Fraction) \< 40%
* Emergency surgery or reoperation
* Intraaortic balloon pump placement
* Known allergy to local anesthetics
* Coagulation disorder
* Infection at the block site
* History of sternotomy
* Those with chronic pain complaints and long-term use of analgesics
* Patients who could not be extubated within 12 hours after the operation

Primary outcomes:
measure: Numeric Rating Scale (NRS) at rest
timeFrame: Postoperative 24 hours
measure: Numeric Rating Scale (NRS) during coughing
timeFrame: Postoperative 24 hours
measure: Mean arterial pressure
timeFrame: Postoperative 24 hours
measure: Heart rate
timeFrame: Postoperative 24 hours
measure: Mean arterial pressure
timeFrame: Peroperative
measure: Heart rate
timeFrame: Peroperative
measure: Bispectral Index (BIS)
timeFrame: Peroperative
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Fatih
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Lale Yüceyar, Prof
role: STUDY_CHAIR
affiliation: Istanbul University - Cerrahpasa
name: Nevzat Cem Sayılgan, MD
role: STUDY_DIRECTOR
References:
citation: Fujii S, Vissa D, Ganapathy S, Johnson M, Zhou J. Transversus Thoracic Muscle Plane Block on a Cadaver With History of Coronary Artery Bypass Grafting. Reg Anesth Pain Med. 2017 Jul/Aug;42(4):535-537. doi: 10.1097/AAP.0000000000000607. No abstract available.
citation: Dogan Baki E, Kavrut Ozturk N, Ayoglu RU, Emmiler M, Karsli B, Uzel H. Effects of Parasternal Block on Acute and Chronic Pain in Patients Undergoing Coronary Artery Surgery. Semin Cardiothorac Vasc Anesth. 2016 Sep;20(3):205-12. doi: 10.1177/1089253215576756. Epub 2015 Apr 21.
citation: Hamed MA, Boules ML, Sobhy MM, Abdelhady MA. The Analgesic Efficacy of Ultrasound-Guided Bilateral Transversus Thoracic Muscle Plane Block After Open-Heart Surgeries: A Randomized Controlled Study. J Pain Res. 2022 Mar 5;15:675-682. doi: 10.2147/JPR.S355231. eCollection 2022.
citation: Shokri H, Ali I, Kasem AA. Evaluation of the Analgesic Efficacy of Bilateral Ultrasound-Guided Transversus Thoracic Muscle Plane Block on Post-Sternotomy Pain: A Randomized Controlled Trial. Local Reg Anesth. 2021 Nov 12;14:145-152. doi: 10.2147/LRA.S338685. eCollection 2021.
citation: Abdelbaser II, Mageed NA. Analgesic efficacy of ultrasound guided bilateral transversus thoracis muscle plane block in pediatric cardiac surgery: a randomized, double-blind, controlled study. J Clin Anesth. 2020 Dec;67:110002. doi: 10.1016/j.jclinane.2020.110002. Epub 2020 Jul 24.
citation: Kaya C, Dost B, Dokmeci O, Yucel SM, Karakaya D. Comparison of Ultrasound-Guided Pecto-intercostal Fascial Block and Transversus Thoracic Muscle Plane Block for Acute Poststernotomy Pain Management After Cardiac Surgery: A Prospective, Randomized, Double-Blind Pilot Study. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt A):2313-2321. doi: 10.1053/j.jvca.2021.09.041. Epub 2021 Oct 1.
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.