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ED95 of Lidocaine 1.0% for Filling the Adductor Canal

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pia Jaeger, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT02033356
First received: January 9, 2014
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Healthy
Procedure: Adductor canal block with lidocaine 1%
Drug: Lidocaine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Estimate of the ED95 of Lidocaine 1.0% for Filling the Adductor Canal When Placing an Adductor Canal Block in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • To estimate the ED 95 for the volume needed to fill the adductor canal distally. [ Time Frame: MRI performed 15 minutes post block ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • To investigate the effect of volume on proximal spread to the femoral triangle [ Time Frame: MRI performed 15 minutes post block ] [ Designated as safety issue: No ]
    Evaluated as a binary outcome using MRI

  • Quadriceps muscle strength [ Time Frame: 1 hour post block ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: January 2014
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

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

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

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

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

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

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02033356

Locations
Denmark
Aleris-Hamlet Hospitals Copenhagen
Søborg, Denmark, 2860
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Pia Jaeger, MD Department of Anaesthesia, HOC, Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Pia Jaeger, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02033356     History of Changes
Other Study ID Numbers: SM3-PJ-13, 2013-004462-33
Study First Received: January 9, 2014
Last Updated: April 3, 2014
Health Authority: Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
adductor canal block
volunteers
US-guided peripheral nerve block
lower limb
MRI

Additional relevant MeSH terms:
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 27, 2014