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Interpectoral-pectoserratus plane block for minimally invasive aortic valve replacement via right anterior minithoracotomy: A single centre, prospective, double-blind, randomized controlled superiority trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509786-21-00
Enrollment
144
Registered
2024-06-26
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve disease

Brief summary

The cumulative opioid consumption in the first 48 postoperative hours after the completion of the surgical procedure in patients undergoing AVR-RAT procedures which is expressed in OMEs

Detailed description

Number of episodes of postoperative pain (NRS score ≥ 4) at rest and at deep inspiration in the first 48 postoperative hours after the completion of the surgical procedure, Time to need for rescue medication for breakthrough pain (e.g. tramadol, oxycodone) in the first 48 postoperative hours after the completion of the surgical procedure, Number of patients with respiratory complications, leading to non-invasive ventilation (NIV) or high-flow nasal cannula (HFNC) oxygen therapy, orotracheal intubation for more than 24 hours or orotracheal re-intubation, Levels of PaCO2 measured every 4 hours during the 48 postoperative hours after the completion of the surgical procedure or until ICU discharge, whichever occurs first, Postsurgical recovery by QoR-15NL questionnaire on day before, first, second and seventh day after surgery, Number of episodes of PONV in the first 48 postoperative hours, Time to extubation of the patient in the ICU, Number of hours spent in the ICU (until ready for discharge), Number of days in the hospital between surgery and first hospital discharge, The quality of life (QoL) by the EQ-5D questionnaire on the day before surgery and 30 days after surgery, Number of days alive and at home after surgery (DAH30), Vital status at 30 days after surgery

Interventions

Sponsors

Az Maria Middelares Gent
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The cumulative opioid consumption in the first 48 postoperative hours after the completion of the surgical procedure in patients undergoing AVR-RAT procedures which is expressed in OMEs

Secondary

MeasureTime frame
Number of episodes of postoperative pain (NRS score ≥ 4) at rest and at deep inspiration in the first 48 postoperative hours after the completion of the surgical procedure, Time to need for rescue medication for breakthrough pain (e.g. tramadol, oxycodone) in the first 48 postoperative hours after the completion of the surgical procedure, Number of patients with respiratory complications, leading to non-invasive ventilation (NIV) or high-flow nasal cannula (HFNC) oxygen therapy, orotracheal intubation for more than 24 hours or orotracheal re-intubation, Levels of PaCO2 measured every 4 hours during the 48 postoperative hours after the completion of the surgical procedure or until ICU discharge, whichever occurs first, Postsurgical recovery by QoR-15NL questionnaire on day before, first, second and seventh day after surgery, Number of episodes of PONV in the first 48 postoperative hours, Time to extubation of the patient in the ICU, Number of hours spent in the ICU (until ready for disc

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026