ED95 of Lidocaine 1.0% for Filling the Adductor Canal

Overview

The aim of this prospective dose finding study is to estimate the minimal effective volume (ED95) for lidocaine 1.0% for filling the adductor canal when placing an adductor canal block. We will apply the Continual Reassessment Method (CRM) for estimating the ED95 and use an MRI scan to evaluate the main objective and ensure spread to the distal part of the adductor canal.

Full Title of Study: “An Estimate of the ED95 of Lidocaine 1.0% for Filling the Adductor Canal When Placing an Adductor Canal Block in Healthy Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2014

Interventions

  • Procedure: Adductor canal block with lidocaine 1%
    • US-guided adductor canal block
  • Drug: Lidocaine

Arms, Groups and Cohorts

  • Experimental: ACB with 30 ml lidocaine 1%
    • Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study. Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
  • Experimental: ACB with 25 ml lidocaine 1%
    • Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study. Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
  • Experimental: ACB with 20 ml lidocaine 1%
    • Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study. Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
  • Experimental: ACB with 15 ml lidocaine 1%
    • Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study. Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
  • Experimental: ACB with 10 ml lidocaine 1%
    • Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study. Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
  • Experimental: ACB with 5 ml lidocaine 1%
    • Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study. Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.

Clinical Trial Outcome Measures

Primary Measures

  • To estimate the ED 95 for the volume needed to fill the adductor canal distally.
    • Time Frame: MRI performed 15 minutes post block
    • This will be evaluated as a binary outcome using MRI; where the adductor canal is considered to be filled if the lidocaine injectate can be identified inside the canal in the first slice distally to the insertion of the adductor longus muscle on femur.

Secondary Measures

  • To investigate the effect of volume on proximal spread to the femoral triangle
    • Time Frame: MRI performed 15 minutes post block
    • Evaluated as a binary outcome using MRI
  • Quadriceps muscle strength
    • Time Frame: 1 hour post block
    • To investigate the effect of volume on quadriceps muscle strength, assessed as maximum voluntary isometric contraction (MVIC) and evaluated as a binary outcome (reduction by more or less than 25%).
  • Pin prick test
    • Time Frame: 1 hour post block
    • To investigate the effect of volume on sensory block assessed by pin-prick in the saphenous innervation area and in the popliteal fossa.
  • Temperature discrimination test
    • Time Frame: 1 hour post block
    • To investigate the effect of volume on sensory block assessed by cold sensation using alchohol swabs, in the saphenous innervation area and in the popliteal fossa.

Participating in This Clinical Trial

Inclusion Criteria

  • 18-30 years – Men – American Society of Anesthesiologists' class 1 – Body Mass Index 18-25 Exclusion Criteria:

  • Allergy to study medication – Earlier trauma or surgery to the lower limb – Diabetes Mellitus – Contraindications to MRI

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Pia Jaeger, MD – Rigshospitalet, Denmark
  • Overall Official(s)
    • Pia Jaeger, MD, Principal Investigator, Department of Anaesthesia, HOC, Rigshospitalet, Denmark

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.