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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05792345
Other study ID # PEPOST 2022-01964
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date June 1, 2025

Study information

Verified date August 2023
Source Centre Hospitalier Universitaire Vaudois
Contact Sylvain Mauron, MD
Phone 0041 79 556 47 31
Email sylvain.mauron@chuv.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

When a patient is to undergo heart surgery with a sternotomy, a transthoracic block is performed. The thoracic block is an analgesic technique which consists of injecting anesthetic product into the nerves, in order to avoid significant pain. The common technique is to make injections in the sternum by the surgeon. A new, increasingly widespread method is performed by the anesthetist who performs the block under ultrasound. This research project aims to determine if performing this transthoracic block under ultrasound is more effective than injections performed by the surgeon without ultrasound.


Description:

Cardiac surgery, and more specifically associated sternotomy, leads to severe pain in the postoperative period. Adequate analgesia is therefore challenging, but of paramount importance to reduce associated side effects such as pulmonary hypertensive crisis, tachyarrhythmia, systemic hypertension, hypoxia, and increased morbidity and length of stay. Actual opioid crisis and risks associated with intravenous analgesics raises the question of having an alternative and better approach to relieve severe pain. Currently in the postoperative suites opiates are also used for sedative purposes. This strategy of sedation has to change. Recent advances in regional anaesthesia could be the answer. Thoracic epidural or paravertebral blocks provide effective analgesia for open cardiac surgery in paediatric patients. However, the major risk of epidural hematomas caused by heparinization, hemodynamic instability, technical difficulties and pneumothorax has limited the application of these two techniques in open cardiac surgery, and promoted the development of new approaches with safe, reliable, and cost-effective techniques, such as ultrasound-guided peripheral nerve blocks. This might be the most effective method for pain management in paediatric patients undergoing cardiac surgery according to recent studies. Superficial Thoracic Transversus Muscle Plane Block has been recently described and evaluated for pain management in adult cardiac surgery. It works through the blockade of multiple anterior branches of the intercostal nerves (Th2-6) in the internal mammary region. It has also been described in children in a few papers: Zhang and al. in a randomized controlled trial in 100 children, Abdelbaser and al. conducted a randomized double blind study including 80 children. In these studies, the injection of local anaesthetics was made between the intercostal and transversus thoracis muscles. But in very small children, the risk of pleura or internal mammary artery puncture associated with this injection is relatively important. Superficial TTMPB (located between the intercostal and pectoralis major muscles) seems to have the same analgesic potency without the aforementioned risks.That is to say that TTMPB is better than nothing but, to our knowledge, there is no study comparing infiltration by surgeon and TTMPB. The risks of the procedure are the same with all regional anaesthesia, which are vascular or nerves punction, hematoma and failure of anaesthesia. This study is set up to test the hypothesis that analgesia performed by TTMPB may have a better antalgic effect than blocks made by surgeons, in patients who undergo cardiac sternotomy. At first, the standard in CHUV was injections made by surgeon. Nowadays the decision of technic used is made with a discussion between anesthesist and surgeon during operative time. The investigators want to bring an evidence based decision with this study.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 140
Est. completion date June 1, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender All
Age group N/A to 16 Years
Eligibility Inclusion Criteria: - All patients undergoing sternotomy for a cardiac surgery in CHUV, which is an academic hospital in Switzerland. Participants fulfilling all of the following inclusion criteria are eligible for the study : - Informed Consent as documented by signature. - Age from 0 to 16 years old. - Undergoing cardiac surgery with sternotomy in CHUV, Lausanne. Exclusion Criteria: - • Patients older than 16 years. - Pregnancy. - Sternotomy for operation other than cardiac surgery. - Contraindication to local anesthesic, e.g. known hypersensitivity or allergy to Bupivacaine. - Infection at the site of injection. - Not having consented for this procedure/ refusal of participation. Reoperation during the same hospitalisation.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Transversus Thoracic Muscle Plane Block
The transversus thoracic muscle plane block It is most commonly performed following cardiothoracic surgeries (or any surgeries requiring sternotomy) to provide analgesia to the anterior chest wall. he TTMPB, and thoracic fascial plane blocks, are increasingly being employed as part of enhanced recovery after surgery (ERAS) protocols for cardiothoracic procedures. They have been shown to significantly reduce both the time to extubation and the incidence of acute and chronic perioperative pain
Control
Infiltration by surgeon

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois

References & Publications (7)

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. — View 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. — View Citation

Bettex DA, Schmidlin D, Chassot PG, Schmid ER. Intrathecal sufentanil-morphine shortens the duration of intubation and improves analgesia in fast-track cardiac surgery. Can J Anaesth. 2002 Aug-Sep;49(7):711-7. doi: 10.1007/BF03017451. English, French. — View Citation

Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137. — View Citation

Ohgoshi Y, Ino K, Matsukawa M. Ultrasound-guided parasternal intercostal nerve block. J Anesth. 2016 Oct;30(5):916. doi: 10.1007/s00540-016-2202-5. Epub 2016 Jun 20. No abstract available. — View Citation

Ueshima H, Kitamura A. Blocking of Multiple Anterior Branches of Intercostal Nerves (Th2-6) Using a Transversus Thoracic Muscle Plane Block. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):388. doi: 10.1097/AAP.0000000000000245. No abstract available. — View Citation

Zhang Y, Chen S, Gong H, Zhan B. Efficacy of Bilateral Transversus Thoracis Muscle Plane Block in Pediatric Patients Undergoing Open Cardiac Surgery. J Cardiothorac Vasc Anesth. 2020 Sep;34(9):2430-2434. doi: 10.1053/j.jvca.2020.02.005. Epub 2020 Feb 11. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Opioids dose Opioids dose administered for analgesia in mg and divided by patient weight in kg Day 0, Hour 24 post-operative.
Secondary Opioids dose Opioids dose administered for analgesia in mg and divided by patient weight in kg Day 0 at Hour 4, 12 and Day 1 post-operative
Secondary Time to extubation Time to extubation in minutes From the time of arrival in the Intensive Care Unit until the time of extubation assessed up to 3 months
Secondary Dose of catecholamine (noradrenaline) used Total dose per kg infused At Day 0 Hour 4, 12, 24 and Day 1 post-operative
Secondary Length of stay in ICU before discharge Length of stay in ICU before discharge in days From the time of arrival in the Intensive Care Unit until discharge assessed up to 3 months
Secondary Adverse Event Analysis of adverse events and adverse events of special interest (complications) such as hematomas, arterial puncture, fail of the block, pneumothorax. Day 1 post operatively
Secondary FLACC pain scale (Face, Legs, Activity, Cry, Consolability) Postoperative pain evaluated by the Flacc pain scale, From 0 to 10 were 10 is the worst pain experimented by the patient and 0 is the normal state. at Day 0 at Hours 4, 12 and 24 post-operative;
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