Coronary Artery DiseasePARACABSNCT04849117
Effect of Bilateral Transversus Thoracis Muscle Plane Block in Patients Undergoing Coronary Artery Bypass Graft Surgery.
An observational study of Coronary Artery Disease and Pain Syndrome, run by University Hospital, Montpellier at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Pain Syndrome
- What is being tested?
- Ultrasound guided Bilateral Transversus Thoracis Muscle Plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 20 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- To be over 18
- To be scheduled for CABG surgery in the center of the study during the study period.
Who cannot join
- 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:
Show all 9Show fewer
- Postoperative prolonged sedation in ICU (> 12 hours)
- Postoperative surgical complication requiring surgical revision during the first two days.
- Opposition to data collection expressed secondarily
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
- Conditions
- Coronary Artery Disease, Pain Syndrome
- Being tested
- Ultrasound guided Bilateral Transversus Thoracis Muscle Plane block
- Keywords
- Cardiac Surgery, Coronary Artery Bypass Graft Surgery, Regional Anesthesia, Transversus Thoracis Muscle Plane Block, Enhanced Recovery After Surgery, Pain, evaluated by visual analog scale score.
- Medical subject headings
- Coronary Artery Disease, Somatoform Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided Bilateral Transversus Thoracis Muscle Plane blockProcedure or surgery
Also called Transversus Thoracis Muscle Plane Block. Parasternal 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Ultrasound guided Bilateral Transversus Thoracis Muscle Plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: postoperative day 2
Secondary outcomes (14)
Postoperative pain assessed
Postoperative pain assessed by visual analog scale (VAS) scoring
Measured: postoperative day 0, 1 and 2
Postoperative nausea and vomiting
Postoperative nausea and vomiting
Measured: hospital day 7
Occurrence of prurit
Occurrence of prurit
Measured: postoperative day 7
rate of Delirium
rate of Delirium
Measured: postoperative day 7
rate of Constipation
rate of Constipation
Measured: postoperative day 7
rate of Urinary retention
rate of Urinary retention
Measured: until postoperative day 7
rate of Hypotension
rate of Hypotension
Measured: until postoperative day 7
Pleural drain duration
Pleural drain duration
Measured: day 20
Urinary catheter duration
Urinary catheter duration
Measured: day 20
Duration of hospitalization in ICU
Duration of hospitalization in ICU
Measured: day 20
In-hospital length of stay
In-hospital length of stay
Measured: day 20
Occurrence of atrial fibrillation
Occurrence of atrial fibrillation
Measured: until postoperative day 7
rate of Pneumonia
rate of Pneumonia
Measured: until postoperative day 7
acute kidney injury
acute kidney injury
Measured: until postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 Jan 2018
- Primary completion1 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Sentenac, MD, PhD, Principal investigator, UH MONTPELLIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849117
- Sponsor's protocol ID
- RECHMPL19_0582
- Acronym
- PARACABS
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04849117
- Acronym / sponsor ID
- PARACABS / RECHMPL19_0582
- Conditions
- Coronary Artery Disease, Pain Syndrome
- Keywords
- Cardiac Surgery, Coronary Artery Bypass Graft Surgery, Regional Anesthesia, Transversus Thoracis Muscle Plane Block, Enhanced Recovery After Surgery, Pain, evaluated by visual analog scale score.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Procedure: Ultrasound guided Bilateral Transversus Thoracis Muscle Plane blockPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- To be over 18
- To be scheduled for CABG surgery in the center of the study during the study period.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided Bilateral Transversus Thoracis Muscle Plane blockAlso: Transversus Thoracis Muscle Plane Block. Parasternal 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. | Procedure or surgery | Bilateral TTMP block + systemic analgesia |
Primary outcome
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.
14 secondary outcomes
Postoperative pain assessed
Time frame: postoperative day 0, 1 and 2
Postoperative nausea and vomiting
Time frame: hospital day 7
Occurrence of prurit
Time frame: postoperative day 7
rate of Delirium
Time frame: postoperative day 7
rate of Constipation
Time frame: postoperative day 7
rate of Urinary retention
Time frame: until postoperative day 7
rate of Hypotension
Time frame: until postoperative day 7
Pleural drain duration
Time frame: day 20
Urinary catheter duration
Time frame: day 20
Duration of hospitalization in ICU
Time frame: day 20
In-hospital length of stay
Time frame: day 20
Occurrence of atrial fibrillation
Time frame: until postoperative day 7
rate of Pneumonia
Time frame: until postoperative day 7
acute kidney injury
Time frame: until postoperative day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Sentenac, MD, PhD principal investigator
UH MONTPELLIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Pain Syndrome, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cumulative morphine consumption (time frame: postoperative day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.