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Minimal local anaesthetic volumes for sciatic nerve blockade: A clinical evaluation of an a volume which was used in a further volunteers study

Minimal local anaesthetic volumes for sciatic nerve blockade: A clinical evaluation of ED99 volumes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-005075-14-AT
Enrollment
Unknown
Registered
2013-10-11
Start date
2013-11-25
Completion date
Unknown
Last updated
2014-10-27

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

Conditions

Patients scheduled for forefoot surgery are performed an ultrasound guided block. We will evaluate the clinical application of previously evaluated experimental data regarding volume reduction of LA´s for peripheral nerve blockade. Aim is to prove if the little amount of volume which was tested in a volunteers´study effects sufficient conditions for surgical anaesthesia and analgesia.

Interventions

Trade Name: Naropin 7,5mg/ml Product Name: Ropivacain-Hydrochlorid Product Code: 1–21500 Pharmaceutical Form: Solution for injection INN or Proposed INN: Ropivacaine CAS Number: 98717-15-8 Current Sp

Sponsors

Medizinische Universität Wien
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Patients undergoing plastic-reconstructive surgery in the supply area of the sciatic nerve •Age between 18 and 90 years. •BMI =65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: •Known allergy or hypersensitivity against study drug or drug class •Participation in another clinical study •Abnormalities in ECG that are considered clinically relevant such AV-block or bradycardia •Unreliability or lack of cooperation •Other objections to participate in the study in the opinion of the investigator

Design outcomes

Primary

MeasureTime frame
Main Objective: The main objective of the study is to investigate if the previously evaluated ED99 for ultrasound guided peripheral nerve blockade is transferable for surgical anaesthesia and analgesia.;Secondary Objective: not applicable;Primary end point(s): Achievement of anaesthesia and analgesia for surgical conditions;Timepoint(s) of evaluation of this end point: - Pinbrick and motor block tests prior to block and 2, 4, 6, 8, 10, 15, 20, 30, 45 and 60 minutes after the block - 30minutes postoperative until full recovery—

Secondary

MeasureTime frame
Secondary end point(s): Onset of sensory and motor blockade, duration of sensory and motor blockade;Timepoint(s) of evaluation of this end point: - Pinbrick and motor block tests prior to block and 2, 4, 6, 8, 10, 15, 20, 30 and 60 minutes after the block - 30minutes postoperative until full recovery—

Countries

Austria

Contacts

Public ContactDaniela Marhofer

Medizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie

daniela.marhofer@meduniwien.ac.at+431404004100

Outcome results

None listed

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