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Comparison of ultrasound guided interscalene brachial plexus block with 10 ml vs 20 ml ropivacaine 0.5%

Comparison of ultrasound guided interscalene brachial plexus block with 10 ml vs 20 ml ropivacaine 0.5% -

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-002484-21-AT
Enrollment
Unknown
Registered
2011-06-15
Start date
2011-07-22
Completion date
Unknown
Last updated
2012-09-25

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

Conditions

different volumes (10 vs 20mL) of ropvacaine 0.5 %will be investigated, when used for interscalene brachial plexus block in shoulder surgery

Interventions

Trade Name: Naropin Pharmaceutical Form: Injection CAS Number: 132112-35-7 Other descriptive name: ROPIVACAINE HYDROCHLORIDE MONOHYDRATE Concentration unit: mg/ml milligram(s)/millilitre Concentration

Sponsors

Universitätsklinik für Anästhesie - Paracelsus Medizinische Universität Salzburg
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients > 18 years Patients undergoing arthroscopy of the shoulder ASA I – III German speaking Able to cooperate in pain assessment 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with a contra-indication for interscalene brachial plexus block Allergy to ropivacaine or other amide local anesthetics Preexisting respiratory compromise Preexisting sensory or motor block Chronic pain and taking > 30 mg oral morphine or equivalent per day Participation in another study

Design outcomes

Primary

MeasureTime frame
Main Objective: We aim to evaluate whether the use of ultrasound guidance and decreased volumes of local anesthetic (10 ml ropivacaine 0.5%) is as effective as larger volumes of local anesthetic (20 ml ropivacaine 0.5%), with less side effects.;Secondary Objective: Comparison of the quality of analgesia defined as average VRS score over 24 hours Time to complete resolution of sensory block and motor block will be analyzed between the two groups. Comparison the amount of additional pain medication used over a period of 24 hours in both groups Comparison the overall patient satisfaction regarding the anesthetic technique in both groups ;Primary end point(s): Time to first request of analgesia will be the primary endpoint;Timepoint(s) of evaluation of this end point: Time of request, noted in CRF—

Secondary

MeasureTime frame
Secondary end point(s): Comparison of the quality of analgesia defined as average VRS score over 24 hours Time to complete resolution of sensory block and motor block will be analyzed between the two groups. Comparison the amount of additional pain medication used over a period of 24 hours in both groups Comparison the overall patient satisfaction regarding the anesthetic technique in both groups ;Timepoint(s) of evaluation of this end point: perioperative beginning 120, 180, 240 minutes after brachial plexus block, then every two hours till 10pm. no evaluation during night, beginning again next morning. over all duration max 24 hrs—

Countries

Austria

Contacts

Public ContactUniversitätsklinik für Anästhesie

Universitätsklinik für Anästhesie - Paracelsus Medizinische Universität Salzburg

4366244822701

Outcome results

None listed

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