- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT04849117
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).
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Montpellier, Frankreich, 34295
- UH Montpellier
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
"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.
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Kohorte
- Zeitperspektiven: Retrospektive
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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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.
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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.
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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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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cumulative morphine consumption
Zeitfenster: postoperative day 2
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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.
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postoperative day 2
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Postoperative pain assessed
Zeitfenster: postoperative day 0, 1 and 2
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Postoperative pain assessed by visual analog scale (VAS) scoring
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postoperative day 0, 1 and 2
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Postoperative nausea and vomiting
Zeitfenster: hospital day 7
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Postoperative nausea and vomiting
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hospital day 7
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Occurrence of prurit
Zeitfenster: postoperative day 7
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Occurrence of prurit
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postoperative day 7
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rate of Delirium
Zeitfenster: postoperative day 7
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rate of Delirium
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postoperative day 7
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rate of Constipation
Zeitfenster: postoperative day 7
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rate of Constipation
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postoperative day 7
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rate of Urinary retention
Zeitfenster: until postoperative day 7
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rate of Urinary retention
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until postoperative day 7
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rate of Hypotension
Zeitfenster: until postoperative day 7
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rate of Hypotension
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until postoperative day 7
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Pleural drain duration
Zeitfenster: day 20
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Pleural drain duration
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day 20
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Urinary catheter duration
Zeitfenster: day 20
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Urinary catheter duration
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day 20
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Duration of hospitalization in ICU
Zeitfenster: day 20
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Duration of hospitalization in ICU
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day 20
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In-hospital length of stay
Zeitfenster: day 20
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In-hospital length of stay
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day 20
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Occurrence of atrial fibrillation
Zeitfenster: until postoperative day 7
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Occurrence of atrial fibrillation
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until postoperative day 7
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rate of Pneumonia
Zeitfenster: until postoperative day 7
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rate of Pneumonia
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until postoperative day 7
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acute kidney injury
Zeitfenster: until postoperative day 7
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acute kidney injury
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until postoperative day 7
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Pierre Sentenac, MD, PhD, UH Montpellier
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RECHMPL19_0582
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Klinische Studien zur Ultrasound guided Bilateral Transversus Thoracis Muscle Plane block
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