Efficacy of Transversus Thoracis Muscle Plane Block in Patients Undergoing Cardiac Surgery (TTMP_Block)

Efficacy of Transversus Thoracis Muscle Plane Block in Patients Undergoing Cardiac Surgery. A Randomized Controlled, Double Blind Trial

The goal of this randomized double blind study is to evaluate the analgesic efficacy of Transversus Thoracis Muscle Plane Block in patients undergoing cardiac surgery with median sternotomy.

one group of participants will receive multimodal analgesia plus ultrasound-guided Transversus Thoracis Muscle Plane Block with ropivacaine 0.5 % after induction of general anesthesia, the other group will receive multimodal analgesia without a bloc.

The investigators want to know if participants who receive the Transversus Thoracis Muscle Plane Block with ropivacaine have less pain than participants who do not receive a block.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Other: ultrasound-guided Transversus Thoracis Muscle Plane Block

Detailed Description

Participants who undergo elective cardiac surgery with median sternotomy are eligible. They will receive general anaesthesia with multimodal analgesia as is standard in our institution. For study purposes participants will be randomized in a double blinded fashion to receive a Transversus Thoracis Muscle Plane Block with 30 mL of ropivacaine 0.5 %, or no block. As the block is carried out after induction of general anesthesia the participants will not know to which group they are assigned.

all blocks will be carried out after induction of general anesthesia, under full sterile precautions, and with ultrasound guidance. multimodal analgesia intra- and postoperatively is standardized and consists of: sufentanil, ketamine, dexmedetomidine, dexamethasone, paracetamol, metamizole, IV morphine in ICU.

The investigators aim for fast track surgery, i.e. extubation either in the operating room or in ICU within the first 6 postoperative hours.

the primary outcome is postoperative opioid consumption over the first 24 h postoperatively, secondary outcomes are pain scores and opioid-related side effects. all outcomes will be assessed by blinded investigators.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sina Grape, MD, MBA; Phone Number: 8759 +4127603; Email: sina.grape@hopitalvs.ch
• Study Contact Backup: Name: Eric Albrecht, Prof; Phone Number: 213142007 +41; Email: eric.albrecht@chuv.ch

Study Locations

• Switzerland
  • Sion, Switzerland, 1950
    • Hopital du Valais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • Informed consent

  • Major adult (≥ 18 years old)
  • Body weight ≥ 50 kg. 50 kg is the minimal weight to ensure that participants will not receive an overdose of local anesthetic (ropivacaine 3 mg/kg)
  • Primary cardiac surgery via a sternotomy approach
  • Planned for fast-track procedure (i.e. postoperative extubation time of maximum six hours)

Exclusion Criteria:

• • Participation in another study within the 30 days preceding and during the present study

  • Refusal and/or inability to understand or sign the informed consent
  • Emergency cardiac surgery
  • Previous cardiac surgery
  • Hypersensitivity or allergy to ropivacaine and other amide-class LA
  • History of chronic pain
  • History of substance abuse
  • Severe cardiac dysfunction (i.e. LVEF ≤ 35%)
  • Severe obesity (BMI > 40kg/m2)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Block + multimodal analgesia; Multimodal analgesia + TTMP block with ropivacaine 0.5 %, 30 mL	Other: ultrasound-guided Transversus Thoracis Muscle Plane Block; block with ropivacaine 0.5 %, 30 mL
No Intervention: Multimodal Analgesia; Multimodal Analgesia without a block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid consumption	cumulative intravenous morphine-equivalents	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain 2 h	Numeric Rating Scale 0-10	2 hours postoperatively
Postoperative pain 6	Numeric Rating Scale 0-10	6 hours postoperatively
Postoperative pain 12	Numeric Rating Scale 0-10	12 hours postoperatively
Postoperative pain 24	Numeric Rating Scale 0-10	24 hours postoperatively
ICU length of stay	ICU length of stay	5 days

Collaborators and Investigators

• Sponsor: Hôpital du Valais

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: TTMP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No