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

Coronary Artery Disease Clinical Trial

— PARACABS  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04849117
• Other study ID #: RECHMPL19_0582
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: March 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 20, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Pain Syndrome

Intervention

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.

Locations

Country	Name	City	State
France	Uh Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

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