ED95 of Lidocaine 1.0% for Filling the Adductor Canal

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02033356
• Other study ID #: SM3-PJ-13
• Secondary ID: 2013-004462-33
• Status: Completed
• Phase: Phase 2
• First received: January 9, 2014
• Last updated: April 3, 2014
• Start date: January 2014
• Est. completion date: February 2014

Study information

• Verified date: April 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

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

Drug:
• Lidocaine

Locations

Country	Name	City	State
Denmark	Aleris-Hamlet Hospitals Copenhagen	Søborg

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the ED 95 for the volume needed to fill the adductor canal distally.	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	No
Secondary	To investigate the effect of volume on proximal spread to the femoral triangle	Evaluated as a binary outcome using MRI	MRI performed 15 minutes post block	No
Secondary	Quadriceps muscle strength	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	No
Secondary	Pin prick test	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	No
Secondary	Temperature discrimination test	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	No