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The effect of the amount (dose and volume) of local anesthetic on the duration of the anesthesia of the arm.

Effect of local anesthetic dose versus volume on block duration of single shot ultrasound-guided axillary brachial plexus block with mepivacaine - VolCon

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-001704-38-NL
Enrollment
Unknown
Registered
2012-05-21
Start date
2012-06-14
Completion date
Unknown
Last updated
2014-08-28

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

Conditions

Patients scheduled for single shot axillary brachial plexus block for hand, wrist, or forearm orthopedic surgery MedDRA version: 14.1 Level: LLT Classification code 10038286 Term: Regional nerve block System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Mepivacaine Product Name: mepivacaine Pharmaceutical Form: Solution for injection CAS Number: 1722-62-9 Other descriptive name: MEPIVACAINE HYDROCHLORIDE Concentration unit: mg/ml milligra

Sponsors

Sint Maartenskliniek
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Patients = 18 years - ASA physical status classification I – III - Patients undergoing single shot ABPB for hand, wrist, or forearm orthopedic surgery - Written informed consent 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 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45

Exclusion criteria

Exclusion criteria: - Contra-indications for regional anesthesia - Known hypersensitivity to amide-type local anesthetics - Known history of peripheral neuropathy

Design outcomes

Primary

MeasureTime frame
Main Objective: The purpose of the present study is to determine the effect of mepivacaine dose and volume on the duration of sensory axillary brachial plexus block (overall and individual nerves).;Secondary Objective: The effect of dose and volume on: duration of motor block (overall and individual nerves); onset of sensory and motor block (overall and individual nerves); Time To First Request of postoperative analgesia (TTFR); and satisfaction (NRS 0-10) with anesthetic technique;Primary end point(s): Duration of sensory ABPB (overall and individual nerves).;Timepoint(s) of evaluation of this end point: Block duration will be tested every 15 minutes postoperatively in patients who participate in this study until the block has resolved completely (approximately 6h after injection of loading dose)—

Secondary

MeasureTime frame
Secondary end point(s): Duration of motor block (overall and individual nerves) Onset of sensory and motor block (overall and individual nerves), Time to first request for postoperative analgesia Satisfaction (NRS 0-10) with the anesthetic technique ;Timepoint(s) of evaluation of this end point: Block duration will be tested every 15 minutes postoperatively in patients who participate in this study until the block has resolved completely (approximately 6h after injection of loading dose) Onset will be assessed every 5 minutes during 30 minutes after initial loading dose Time To First Request for postoperative analgesia and satisfaction with the anesthetic technique will be assessed upon conclusion of the study (time is as the block has resolved completely, approximately 6h after injection of loading dose)—

Countries

Netherlands

Contacts

Public ContactClinical Trials Information

Sint Maartenskliniek

k.schoenmakers@maartenskliniek.nl+3124365 9935

Outcome results

None listed

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