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Completed

NCT Number: NCT02033356

ED95 of Lidocaine 1.0% for Filling the Adductor Canal

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.

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Key information

Conditions

Healthy

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Aleris-Hamlet Hospitals Copenhagen

Søborg, 2860, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adductor canal block with lidocaine 1%

Procedure

US-guided adductor canal block

Lidocaine

Drug

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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%).

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

An Estimate of the ED95 of Lidocaine 1.0% for Filling the Adductor Canal When Placing an Adductor Canal Block in Healthy Volunteers

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 10, 2014
Registry last updated
Apr 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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