Tilsætning af sufentanil til interskalenerblokade ved skulderoperation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-015752-22-DK

Enrollment

Registered

2009-11-09

Start date

2009-11-24

Completion date

Unknown

Last updated

2021-08-02

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

Conditions

Postoperative smerter efter arthroskopisk skulderoperation MedDRA version: 12.0 Level: LLT Classification code 10003393 Term: Arthropathy, unspecified, involving shoulder region

Interventions

Trade Name: Naropin Pharmaceutical Form: Injection* INN or Proposed INN: ROPIVACAINE HYDROCHLORIDE CAS Number: 0 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * skulderoperation * ASA I-III * alder 18-80 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: * graviditet * Svær KOL * intolerans overfor Keton/sufentani * kroniske smerter (fast opioidbehandling) * RA * DM med polyneuropathi * Kontraindikationer i hht. produktresume * kontraindikation mod anlæggelse af interskalenerblokade

Design outcomes

Primary

Measure	Time frame
Main Objective: Undersøgelsen skal afklare om varigheden af den smertedæmpende virkning af interskalenerblokade med ropivacain forlænges ved tilsætning af sufentanil. ;Secondary Objective: * smerteniveau (værste/gennemsnitlige) * supplerende smertebehandling * bivirkninger;Primary end point(s): Tid til smertedebut af moderate til svære smerter	—

Countries

Denmark

Outcome results

None listed

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