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

NCT06239025 | Completed Phase 4 DMC

• 1 other identifier: TTMP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• opioid consumption

  cumulative intravenous morphine-equivalents

  24 hours postoperatively

Secondary Outcomes (5)

• Postoperative pain 2 h

  2 hours postoperatively

• Postoperative pain 6

  6 hours postoperatively

• Postoperative pain 12

  12 hours postoperatively

• Postoperative pain 24

  24 hours postoperatively

• ICU length of stay

  5 days

Study Arms (2)

Block + multimodal analgesia

ACTIVE COMPARATOR

Multimodal analgesia + TTMP block with ropivacaine 0.5 %, 30 mL

Other: ultrasound-guided Transversus Thoracis Muscle Plane Block

Multimodal Analgesia

NO INTERVENTION

Multimodal Analgesia without a block

Interventions

ultrasound-guided Transversus Thoracis Muscle Plane Block OTHER

block with ropivacaine 0.5 %, 30 mL

Block + multimodal analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hôpital du Valais: lead

Study Sites (1)

Hopital du Valais

Sion, 1950, Switzerland

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: syringes with the study drug will be prepared by a study nurse. the patient, investigators and all carers will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: multimodal analgesia + ultrasound-guided Transversus Thoracis Muscle Plane Block with ropivacaine 0.5 % vs multimodal analgesia alone

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: August 15, 2024
• Primary Completion: May 31, 2025
• Study Completion: June 12, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)