Comparison of Post-operative Analgesia in Pediatric Superficial TTMPB

NCT05792345 | Unknown DMC

• 1 other identifier: PEPOST 2022-01964
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Regional Anesthesia

Keywords

regional anesthesia; pediatric; cardiac

Outcome Measures

Primary Outcomes (1)

• Opioids dose

  Opioids dose administered for analgesia in mg and divided by patient weight in kg

  Day 0, Hour 24 post-operative.

Secondary Outcomes (6)

• Opioids dose

  Day 0 at Hour 4, 12 and Day 1 post-operative

• Time to extubation

  From the time of arrival in the Intensive Care Unit until the time of extubation assessed up to 3 months

• Dose of catecholamine (noradrenaline) used

  At Day 0 Hour 4, 12, 24 and Day 1 post-operative

• Length of stay in ICU before discharge

  From the time of arrival in the Intensive Care Unit until discharge assessed up to 3 months

• Adverse Event

  Day 1 post operatively

Study Arms (2)

Control

OTHER

Infiltration will be performed by surgeon at the site of sternotomy

Procedure: Control

With TTMPB

ACTIVE COMPARATOR

Regional anesthesia is performed with direct view of the nerves and vascular position

Procedure: Transversus Thoracic Muscle Plane Block

Interventions

Transversus Thoracic Muscle Plane Block PROCEDURE

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

With TTMPB

Control PROCEDURE

Infiltration by surgeon

Control

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All patients undergoing sternotomy for a cardiac surgery in CHUV, which is an academic hospital in Switzerland.
• Informed Consent as documented by signature.
• Age from 0 to 16 years old.
• Undergoing cardiac surgery with sternotomy in CHUV, Lausanne.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Related Publications (7)

• 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.

  PMID: 12193491 BACKGROUND

• 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.

  PMID: 24829420 BACKGROUND

• 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.

  PMID: 32665179 BACKGROUND

• 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.

  PMID: 26079353 BACKGROUND

• 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.

  PMID: 32151511 BACKGROUND

• 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.

  PMID: 32717448 BACKGROUND

• 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.

  PMID: 27325411 BACKGROUND

Study Officials

• Sylvain Mauron, MD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvain Mauron, MD

CONTACT

0041 79 556 47 31; sylvain.mauron@chuv.ch

Emeline Christophel-Plathier

CONTACT

0041 79 556 64 33; emeline.christophel@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, Priva Docent

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 31, 2023
• Study Start: December 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share