Postoperative Pain Relief With Transversus Thoracis Muscle Plane Block After Cardiac Surgery

NCT04916418 | Completed Phase 4

• 2 other identifiers: T39/20212020-004178-23
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the effect of transversus thoracis muscle plane block (TTP), using repeated boluses of ropivacaine via catheter, on postoperative pain and oxycodone consumption after elective cardiac surgery with sternotomy.

Conditions

Pain, Postoperative; Anesthesia, Local; Coronary Artery Disease; Heart Valve Diseases

Keywords

Transversus thoracis muscle pain block; ropivacain

Outcome Measures

Primary Outcomes (1)

• Number of patients with satisfactory pain response measured with visual rating scale (VAS)

  Number of patients with visual rating scale (VAS, 0-100 mm, min 0 mm, max 100 mm, higher score means worse outcome) value under 30 mm

  72 hours

Secondary Outcomes (3)

• Change in opioid consumption (mg) postoperatively

  72 hours

• Patient reported sensation that is considered to be caused by systemic toxicity of ropivacaine.

  72 hours

• Change in the length of stay in the hospital

  up to 24 weeks

Study Arms (2)

G1, Placebo

PLACEBO COMPARATOR

Intravenous saline (NaCl 0,9%) will be administered. G1 group will be administered an initial dose of placebo (20ml) per catheter bilaterally (total volume 40ml) after TTP has been placed. This is followed by 20ml doses of placebo per catheter every 8 hours until 72 hours from the first dose has passed.

Drug: Placebo

G2, Ropivacaine

ACTIVE COMPARATOR

Ropivacaine 0.5%. G2 group will be administered an initial dose of ropivacaine (20 ml) per catheter bilaterally (total volume 40ml) after the TTP has been placed. This is followed by 20 ml doses of ropivacain per catheter every 8 hours until 72 hours from the first dose has passed.

Drug: Ropivacaine

Interventions

Placebo DRUG

TTP block with initial dose of placebo (NaCl0.9%) 20 ml per catheter (total volume 40ml), followed by 20 ml per catheter every 8 hours until 72 hours from the first dose has passed.

G1, Placebo

Ropivacaine DRUG

TTP block with initial dose of ropivacaine 0.5% (5 mg / ml) 20 ml per catheter (total volume 40ml), followed by doses of ropivacaine 0.2% (2 mg / ml) 20 ml per catheter every 8 hours until 72 hours from the first dose has passed.

G2, Ropivacaine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• The patient is scheduled for open cardiac coronary arterial bypass graft (CABG) OR single heart valve surgery that require median sternotomy under general anesthesia
• Patients that are estimated to be weaned from mechanical ventilator not later than 8 h after surgery
• Patients that are capable of using the patient controlled analgesia device (PCA) after surgery
• Written informed consent from the patient

You may not qualify if:

• A previous history of intolerance to the study drug or related compounds and additives
• Redo surgery
• Combined CABG and heart valve surgery
• Endocarditis and/or mediastinitis.
• Concomitant drug therapy with strong opioids or strong CYP3A4 or CYP2D6 inductor(s) or inhibitor(s) 2 weeks prior to study.
• Patients younger than 18 years or older than 80 years.
• Body weight \< 60 kg
• BMI \> 35, sleep apnoea, any other sleep disorder or condition that requires treatment with continuous positive airway pressure or automatic positive airway pressure device.
• Diagnosed hepatic cirrhosis or kidney disease: GFR \< 29 ml/min/1,73 m2 or dependence on dialysis
• History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent. If the researcher judge, that the patient has a mental health disorder, retardation or other similar reason and do not have the capacity to give his/her consent to research or patient do not understand the meaning of the study, or is not able to use PCA device, the patient is to be exluded. History of alcoholism or drug abuse (especially opioid) may affect the use of opioid PCA device and make harm to the patient or invalid the study and are exluded.
• Cardiac insufficiency, ejection fraction (LVEF) \< 30 %
• Patients with a diagnosis for neuropathic pain or chronic pain syndrome
• Insulin dependent diabetes mellitus with neuropathy
• Participation in any other study concomitantly or within one month prior to the entry into this study
• Donation of blood for 4 weeks prior and during the study

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital and University of Turku

Turku, Finland

Location

MeSH Terms

Conditions

Pain, Postoperative; Coronary Artery Disease; Heart Valve Diseases

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Marko Peltoniemi, MD PhD

  Perioperative Services, Intensive Care Medicine and Pain Management; Turku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 7, 2021
• Study Start: October 15, 2021
• Primary Completion: December 1, 2023
• Study Completion: January 31, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)