Influence of the PECS II block on postoperative pain and opioid demand in patients undergoing minimal invasive cardiac surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005452-11-AT

Enrollment

Registered

2021-11-18

Start date

2022-01-21

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Patients scheduled for minimal invasive cardia surgery

Interventions

Trade Name: Ropinaest 5mg/ml Product Name: Ropinaest 5mg/ml Pharmaceutical Form: Solution for injection INN or Proposed INN: Ropivacain-Hydrochlorid CAS Number: 98717-15-8 Concentration unit: mg/ml mi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - ASA 1-3 - Age: 18 - 80 years - BMI 18 – 35 kg/m2 - informed consent - minimal invasive cardiac surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: - known allergies to administered drugs - Diabetic neuropathy - LV-dysfunction (EF 24 hours - eGFR <30 or chronic renal disease

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the postoperative opioid demand over the first 24 hours after surgery.;Secondary Objective: To assess the postoperative opioid demand over the first 48 hours after surgery, the time to extubation, the duration of hospital stay, the evolution of VAS Score and the OBAS Score after 24 hours. ;Primary end point(s): Total opioid consumption in the first 24 hours;Timepoint(s) of evaluation of this end point: after 24 hours	—

Measure

Time frame

Main Objective: To assess the postoperative opioid demand over the first 24 hours after surgery.;Secondary Objective: To assess the postoperative opioid demand over the first 48 hours after surgery, the time to extubation, the duration of hospital stay, the evolution of VAS Score and the OBAS Score after 24 hours. ;Primary end point(s): Total opioid consumption in the first 24 hours;Timepoint(s) of evaluation of this end point: after 24 hours

—

Secondary

Measure	Time frame
Secondary end point(s): time to first opioid administration, the time to extubation, the duration of hospital stay, the evolution of VAS Score (2, 4, 6, 12, 24 hours) and the OBAS Score after 24 hours.;Timepoint(s) of evaluation of this end point: 24 hours	—

Countries

Austria

Contacts

Public ContactLukas Gasteiger

Medizinische Universität Innsbruck

mui-sponsor@i-med.ac.at0043512900370086

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026