Shoulder nerve blockade for surgery on the shoulder: A comparison of two dosing methods: Fixed limited amounts of local anesthetic injected at fixed times with the possibility of supplementing controlled by the patient Vs. continuous injection of a local anesthetic with the possibility of supplementing controlled by the patient

Interscalener blockade for surgery on the shoulder, a comparison of two dosing regimens: Fixed intermittent bolus with the possibility of PCA (Patient controlled administration) Vs. continuous infusion with the possibility of PCA.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000235-27-DK

Enrollment

Registered

2013-02-19

Start date

2013-02-19

Completion date

Unknown

Last updated

2016-04-11

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

Conditions

Shoulder frcture Rotator cuff leasion Shoulder alluplastic MedDRA version: 16.1 Level: LLT Classification code 10002182 Term: Analgesia System Organ Class: 100000004865

Interventions

Trade Name: Ropivacain, FreseniusKabi solution for infusion 2mg/ml Product Name: Ropivacain Pharmaceutical Form: Solution for infusion INN or Proposed INN: ROPIVACAINE CAS Number: 84057-95-4 Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients over 18 years in need of an interscalenecatheter for shoulder surgery (artificial shoulder joint operaton, operations on the shoulder joint's capsule and fracture of the upper arm). ASA class 1-3. (In otherwise healthy patients (1) Pt. With mild systemic disease (2), Pt. With severe systemic disease, (3) Pt. With severe systemic disease, and in the constant life threatening condition (4). 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Patients requiring intensive therapy before or after surgery. Incapacitated patients. Patients with known allergy to local anesthetics.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigater wether we can reduce pain associated with shoulder surgery by changing the adminitration af local anaesthetic in an interscalene catheter from continuous infusion to intermittent bolus injection;Secondary Objective: To investigater wether we can reduce sideeffekts associated with nerveblockade for shoulder surgery by changing the adminitration af local anaesthetic in an interscalene catheter from continuous infusion to intermittent bolus injection;Primary end point(s): VAS-score;Timepoint(s) of evaluation of this end point: Every 8 hours after blokade 48 hours in total	—

Measure

Time frame

Main Objective: To investigater wether we can reduce pain associated with shoulder surgery by changing the adminitration af local anaesthetic in an interscalene catheter from continuous infusion to intermittent bolus injection;Secondary Objective: To investigater wether we can reduce sideeffekts associated with nerveblockade for shoulder surgery by changing the adminitration af local anaesthetic in an interscalene catheter from continuous infusion to intermittent bolus injection;Primary end point(s): VAS-score;Timepoint(s) of evaluation of this end point: Every 8 hours after blokade 48 hours in total

—

Secondary

Measure	Time frame
Secondary end point(s): Gender, age, weight, type of operation, opioid consumption per and postoperatively. Number of PCA administered.;Timepoint(s) of evaluation of this end point: Every 8 hours after blokade, 48 hours in total	—

Countries

Denmark

Contacts

Public ContactOdense Universitets Hospital

Odense Universitets Hospital

Michael.Due.Nielsen@rsyd.dk00456666113333

Outcome results

None listed

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