ED95 of Lidocaine 1.0% for Filling the Adductor Canal

April 3, 2014 updated by: Pia Jaeger, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Søborg, Denmark, 2860
        • Aleris-Hamlet Hospitals Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Lidocaine
Procedure: Adductor canal block with lidocaine 1%
US-guided adductor canal block
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.
Drug: Lidocaine
Procedure: Adductor canal block with lidocaine 1%
US-guided adductor canal block
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.
Drug: Lidocaine
Procedure: Adductor canal block with lidocaine 1%
US-guided adductor canal block
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.
Drug: Lidocaine
Procedure: Adductor canal block with lidocaine 1%
US-guided adductor canal block
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.
Drug: Lidocaine
Procedure: Adductor canal block with lidocaine 1%
US-guided adductor canal block
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.
Drug: Lidocaine
Procedure: Adductor canal block with lidocaine 1%
US-guided adductor canal block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
MRI performed 15 minutes post block

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
MRI performed 15 minutes post block
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%).
1 hour post block
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.
1 hour post block
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.
1 hour post block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Pia Jaeger, MD, Department of Anaesthesia, HOC, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

January 9, 2014

First Submitted That Met QC Criteria

January 9, 2014

First Posted (Estimate)

January 10, 2014

Study Record Updates

Last Update Posted (Estimate)

April 4, 2014

Last Update Submitted That Met QC Criteria

April 3, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM3-PJ-13
  • 2013-004462-33 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe