Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT05681507

Efficacy of TTMPB in Adult Cardiac Surgery

Conditions: Acute Post Operative Pain

Sex: All
Ages: 18 Years – 100 Years
Phase: NA
Enrollment: 140
Sponsor: Eric Albrecht

Location: Switzerland

Summary

The goal of this clinical trial is to compare the efficacy of Transversus Thoracic Muscle Plane Block (TTMPB) integrated in a modern multimodal analgesia protocol, following the ERAS® recommendations, in adult patients undergoing planned open heart surgery.The main study question is:Does the addition of TTMPB to a standard analgesic protocol significantly improve analgesia following elective open heart surgery?The investigators will primarily compare postoperative opioid consumption and pain scores in patients who will be randomly allocated to one of two groups:The control group will receive standard analgesia per institutional Intensive Care Unit protocol.The intervention group will receive the same standard of care plus a TTMP block (40ml of bupivacaine 0.375%, total dose of 150 mg).The investigators will also study the impact of group allocation on secondary outcomes, such as the rate of early mobilization.

Eligibility Criteria

Inclusion Criteria:Direct informed consent as documented by signatureMajor adult (≥ 18 years old) with body weight ≥ 50 kg. For the record, fifty kilograms is the minimal weight to ensure that participants remain safely away from maximal doses of LA (3 mg/kg)Planned and primary cardiac surgery via a sternotomy approachPlanned for ultra-fast-track procedure (i.e. postoperative extubation time of maximum two hours)Exclusion Criteria:Participation in another study with investigational drug within the 30 days preceding and during the present studyRefusal and/or inability to understand or sign the informed consentEmergent cardiac surgeryPrevious cardiac surgeryKnown hypersensitivity or true allergy to bupivacaine and other amide-class LAChronic pain historySubstance abuse historyInability to follow the procedures of the study (e.g. due to language problems, psychological / psychiatric disorders, dementia)Clinically significant concomitant diseases: severe cardiac dysfunction (i.e. LVEF ≤ 35%); severe chronic obstructive pulmonary disease (i.e. FEV < 50%); severe hepatic disease.Severe obesity (BMI > 35kg/m2)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05681507). StuddyBuddy aggregates publicly available trial information.