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).
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Montpellier, Frankrike, 34295
- Uh Montpellier
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
"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.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Retrospektiv
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
|
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
cumulative morphine consumption
Tidsram: 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.
|
postoperative day 2
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative pain assessed
Tidsram: postoperative day 0, 1 and 2
|
Postoperative pain assessed by visual analog scale (VAS) scoring
|
postoperative day 0, 1 and 2
|
|
Postoperative nausea and vomiting
Tidsram: hospital day 7
|
Postoperative nausea and vomiting
|
hospital day 7
|
|
Occurrence of prurit
Tidsram: postoperative day 7
|
Occurrence of prurit
|
postoperative day 7
|
|
rate of Delirium
Tidsram: postoperative day 7
|
rate of Delirium
|
postoperative day 7
|
|
rate of Constipation
Tidsram: postoperative day 7
|
rate of Constipation
|
postoperative day 7
|
|
rate of Urinary retention
Tidsram: until postoperative day 7
|
rate of Urinary retention
|
until postoperative day 7
|
|
rate of Hypotension
Tidsram: until postoperative day 7
|
rate of Hypotension
|
until postoperative day 7
|
|
Pleural drain duration
Tidsram: day 20
|
Pleural drain duration
|
day 20
|
|
Urinary catheter duration
Tidsram: day 20
|
Urinary catheter duration
|
day 20
|
|
Duration of hospitalization in ICU
Tidsram: day 20
|
Duration of hospitalization in ICU
|
day 20
|
|
In-hospital length of stay
Tidsram: day 20
|
In-hospital length of stay
|
day 20
|
|
Occurrence of atrial fibrillation
Tidsram: until postoperative day 7
|
Occurrence of atrial fibrillation
|
until postoperative day 7
|
|
rate of Pneumonia
Tidsram: until postoperative day 7
|
rate of Pneumonia
|
until postoperative day 7
|
|
acute kidney injury
Tidsram: until postoperative day 7
|
acute kidney injury
|
until postoperative day 7
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Pierre Sentenac, MD, PhD, Uh Montpellier
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RECHMPL19_0582
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .