Comparison of Post-operative Analgesia in Pediatric Superficial TTMPB

Regional Anesthesia Clinical Trial

— PEPOST  

Official title:

Comparison of Post-operative Analgesia in Pediatric Superficial TTMPB

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05792345
• Other study ID #: PEPOST 2022-01964
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Regional Anesthesia

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;