ED95 of Lidocaine 1.0% for Filling the Adductor Canal

NCT02033356 | Completed Phase 2 DMC

• 2 other identifiers: SM3-PJ-132013-004462-33
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

adductor canal block; volunteers; US-guided peripheral nerve block; lower limb; MRI

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• To investigate the effect of volume on proximal spread to the femoral triangle

  MRI performed 15 minutes post block

• Quadriceps muscle strength

  1 hour post block

• Pin prick test

  1 hour post block

• Temperature discrimination test

  1 hour post block

Study Arms (6)

ACB with 30 ml lidocaine 1%

EXPERIMENTAL

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%; Drug: Lidocaine

ACB with 25 ml lidocaine 1%

EXPERIMENTAL

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%; Drug: Lidocaine

ACB with 20 ml lidocaine 1%

EXPERIMENTAL

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%; Drug: Lidocaine

ACB with 15 ml lidocaine 1%

EXPERIMENTAL

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%; Drug: Lidocaine

ACB with 10 ml lidocaine 1%

EXPERIMENTAL

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%; Drug: Lidocaine

ACB with 5 ml lidocaine 1%

EXPERIMENTAL

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%; Drug: Lidocaine

Interventions

Adductor canal block with lidocaine 1% PROCEDURE

US-guided adductor canal block

ACB with 10 ml lidocaine 1%; ACB with 15 ml lidocaine 1%; ACB with 20 ml lidocaine 1%; ACB with 25 ml lidocaine 1%; ACB with 30 ml lidocaine 1%; ACB with 5 ml lidocaine 1%

Lidocaine DRUG

ACB with 10 ml lidocaine 1%; ACB with 15 ml lidocaine 1%; ACB with 20 ml lidocaine 1%; ACB with 25 ml lidocaine 1%; ACB with 30 ml lidocaine 1%; ACB with 5 ml lidocaine 1%

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years
• Men
• American Society of Anesthesiologists' class 1
• Body Mass Index 18-25

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Aleris-Hamlet Hospitals Copenhagen

Søborg, 2860, Denmark

Location

Related Publications (1)

• Jaeger P, Jenstrup MT, Lund J, Siersma V, Brondum V, Hilsted KL, Dahl JB. Optimal volume of local anaesthetic for adductor canal block: using the continual reassessment method to estimate ED95. Br J Anaesth. 2015 Dec;115(6):920-6. doi: 10.1093/bja/aev362.

  PMID: 26582853 DERIVED

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Pia Jaeger, MD

  Department of Anaesthesia, HOC, Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: January 10, 2014
• Study Start: January 1, 2014
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 4, 2014

Record last verified: 2014-04

Locations

DK (1)