Trial intelligence / Profile preview

Dose Effect of Lidocaine on Adductor Canal Block Duration

NCT02172729Phase 4

Key facts

Status
Completed
Start
Jun 2014
Primary completion
Jul 2014
Countries
1
Sponsor
Rigshospitalet
Modality
Small Molecules
01

Overview

Phase 4 trial of lidocaine (2 arms), sponsored by Rigshospitalet. Primary endpoint: Duration of sensory block assessed with pinprick. Started Jun 2014; status: completed.

02

Design

2 arms
  • ACB with lidocaine 5 mg/ml

    Adductor canal block with 20 ml lidocaine 5 mg/ml, single bolus

  • ACB with lidocaine 15 mg/ml

    Adductor canal block with 20 ml lidocaine 15 mg/ml, single bolus

03

Who it enrols

Healthy volunteers (ASA 1) with BMI 18-25, excluding those with diabetes, prior lower limb trauma/surgery, or allergy to study medication.

04

Endpoints

Primary

  • Duration of sensory block assessed with pinprick

Secondary

  • Duration of sensory block assessed by heat pain detection threshold

  • Duration of sensory block assessed by warmth detection threshold

  • Duration of sensory block assessed by pain during 1 minute of warmth stimulation

  • Duration of sensory block assessed by tolerance to transcutaneal electrical stimulation

  • Duration of sensory block assessed by cold sensation with an alcohol swab

  • Duration of motor block assessed as maximum voluntary isometric contraction

  • Time to onset of sensory block assessed by pinprick

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