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

Conditions: Patients scheduled for single shot axillary brachial plexus block for hand, wrist, or forearm orthopedic surgery
MedDRA version: 14.1Level: LLTClassification code 10038286Term: Regional nerve blockSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2012-001704-38-NL

Lead Sponsor: Sint Maartenskliniek

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Duration of motor block (overall and individual nerves)<br>Onset of sensory and motor block (overall and individual nerves), <br>Time to first request for postoperative analgesia <br>Satisfaction (NRS 0-10) with the anesthetic technique<br>;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)<br>Onset will be assessed every 5 minutes during 30 minutes after initial loading dose<br>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)<br>