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

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.

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).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Pain Syndrome
• Intervention / Treatment: Procedure: Ultrasound guided Bilateral Transversus Thoracis Muscle Plane block

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UH Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

"TTMP Block" group : fifty consecutive patients who underwent elective on-pump coronary artery bypass graft ± valve surgery after October 2019, with a postoperative analgesic protocol including a bilateral TTMP block, associate with systemic analgesia.

"Systemic Analgesia" group : age, gender and type of surgery-matched patients who underwent elective on-pump coronary artery bypass graft ± valve surgery before September 2019, with a postoperative analgesic protocol based on systemic analgesia only.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Systemic analgesia; Patients received only systemic analgesia : Acetaminophen, Ketoprofen, and Nefopam were administered systematically. Morphine was administered if necessary, according to our institutional pain management protocol.
Bilateral TTMP block + systemic analgesia; Patients received the same protocol of systemic analgesia associated with a bilateral TTMP block performed during the first four hours after ICU admission, before tracheal tube removal.	Procedure: Ultrasound guided Bilateral Transversus Thoracis Muscle Plane block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cumulative morphine consumption	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.	postoperative day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain assessed	Postoperative pain assessed by visual analog scale (VAS) scoring	postoperative day 0, 1 and 2
Postoperative nausea and vomiting	Postoperative nausea and vomiting	hospital day 7
Occurrence of prurit	Occurrence of prurit	postoperative day 7
rate of Delirium	rate of Delirium	postoperative day 7
rate of Constipation	rate of Constipation	postoperative day 7
rate of Urinary retention	rate of Urinary retention	until postoperative day 7
rate of Hypotension	rate of Hypotension	until postoperative day 7
Pleural drain duration	Pleural drain duration	day 20
Urinary catheter duration	Urinary catheter duration	day 20
Duration of hospitalization in ICU	Duration of hospitalization in ICU	day 20
In-hospital length of stay	In-hospital length of stay	day 20
Occurrence of atrial fibrillation	Occurrence of atrial fibrillation	until postoperative day 7
rate of Pneumonia	rate of Pneumonia	until postoperative day 7
acute kidney injury	acute kidney injury	until postoperative day 7

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Pierre Sentenac, MD, PhD, UH Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Cardiac Surgery; Enhanced Recovery After Surgery; Regional Anesthesia; Coronary Artery Bypass Graft Surgery; Transversus Thoracis Muscle Plane Block; Pain, evaluated by visual analog scale score.
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: RECHMPL19_0582

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

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