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NCT Number: NCT04849117

Effect of Bilateral Transversus Thoracis Muscle Plane Block in Patients Undergoing Coronary Artery Bypass Graft Surgery.

Coronary artery bypass graft surgery is the standard surgical treatment for coronary disease. However, there is no consensus on analgesic management in patients undergoing CABG.

The aim of the study is to evualuate efficacy of bilateral transversus thoracis muscle plane (TTMP) block combined with systemic analgesia, compared to systemic analgesia only, in patients undergoing elective on-pump CABG surgery.

Our main hypothesis is that a bilateral TTMP block performed after CABG surgery could reduce morphine consumption during the first 48 hours.

The investigators conducted an age, gender and type of surgery-matched retrospective cohort study in the Montpellier University Hospital (France).

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Mental Disorders Myocardial Ischemia Neurologic Manifestations Pain Pain Syndrome Pathological Conditions, Signs and Symptoms Signs and Symptoms Somatoform Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uh Montpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • To be over 18
  • To be scheduled for CABG surgery in the center of the study during the study period.

Exclusion criteria

  • Chronic pain or opioid use before surgery
  • Recent thoracic regional analgesia (< 1 month)
  • Preoperative dementia or other neurologic or psychiatric disease incompatible with VAS pain scoring.
  • Other technique of regional anesthesia (e.g. thoracic epidural)
  • Opposition to data collection

Secondary exlusion criteria:

  • Postoperative prolonged sedation in ICU (> 12 hours)
  • Postoperative surgical complication requiring surgical revision during the first two days.
  • Opposition to data collection expressed secondarily

Treatment and study plan

Ultrasound guided Bilateral Transversus Thoracis Muscle Plane block

Procedure

In the "TTMP block" group, an ultrasounded guided TTMP block was performed by an anesthesiologist, in ICU, before tracheal tube removal. Between the 4th et 5th rib, on each side, 40 ml of Ropivacaine 2 mg/ml, in association with Clonidine, was injected "single-shot" in the tranversus thoracis muscle plane. The targets of local anesthetic were the anterior branches of intercostal nerves from T2 to T6. Dexamethasone 8 mg was injected intravenously.

Other names: Transversus Thoracis Muscle Plane Block. Parasternal Block.

Primary outcomes

  1. cumulative morphine consumption

    Time frame: postoperative day 2

    cumulative morphine consumption during the first two days. cumulative morphine consumption on postoperative day 0, 1 and 2, including the morphine administered in intensive care unit, and on postoperative day 1 and 2.

Secondary outcomes

  1. Postoperative pain assessed

    Time frame: postoperative day 0, 1 and 2

    Postoperative pain assessed by visual analog scale (VAS) scoring

  2. Postoperative nausea and vomiting

    Time frame: hospital day 7

    Postoperative nausea and vomiting

  3. Occurrence of prurit

    Time frame: postoperative day 7

    Occurrence of prurit

  4. rate of Delirium

    Time frame: postoperative day 7

    rate of Delirium

  5. rate of Constipation

    Time frame: postoperative day 7

    rate of Constipation

  6. rate of Urinary retention

    Time frame: until postoperative day 7

    rate of Urinary retention

  7. rate of Hypotension

    Time frame: until postoperative day 7

    rate of Hypotension

  8. Pleural drain duration

    Time frame: day 20

    Pleural drain duration

  9. Urinary catheter duration

    Time frame: day 20

    Urinary catheter duration

  10. Duration of hospitalization in ICU

    Time frame: day 20

    Duration of hospitalization in ICU

  11. In-hospital length of stay

    Time frame: day 20

    In-hospital length of stay

  12. Occurrence of atrial fibrillation

    Time frame: until postoperative day 7

    Occurrence of atrial fibrillation

  13. rate of Pneumonia

    Time frame: until postoperative day 7

    rate of Pneumonia

  14. acute kidney injury

    Time frame: until postoperative day 7

    acute kidney injury

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Effect of Bilateral Transversus Thoracis Muscle Plane Block on Postoperative Morphine Consumption in Patients Undergoing Elective On-pump Coronary Artery Bypass Graft Surgery: a Retrospective Study.

Acronym: PARACABS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2021
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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