An estimate of the lowest volume needed to fill the adductor canal when placing an adductor canal block in healthy volunteers

An estimate of the ED95 of lidocain 1.0% for filling the adductor canal when placing an adductor canal block in healthy volunteers

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004462-33-DK

Enrollment

Unknown

Registered

2013-11-22

Start date

2013-12-09

Completion date

Unknown

Last updated

2016-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers (treatment intended for postoperative pain relief in patients after knee surgery) MedDRA version: 14.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865

Interventions

Trade Name: Xylocain Pharmaceutical Form: Solution for injection INN or Proposed INN: Lidocaine Other descriptive name: LIDOCAINE Concentration unit: mg/ml milligram(s)/millilitre Concentration type:

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Men Age 18-30 years ASA 1 Body Mass Index 18-25 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Allergy to study mediacation Earlier trauma or surgery to the lower limb Diabetes Mellitus Contraindications to MRI

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of this prospective dose finding study is to estimate the minmal effective volume (ED95) for lidocaine 1.0% for filling the adductor canal when placing an adductor canal block. We will apply the Continual Reassesment 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. ;Secondary Objective: Secondary objectives are to investigate the effect on volume on spread to the femoral tiangle, muscle strength and sensory block.;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: Evaluated using MRI performed 15 minutes post block	—

Measure

Time frame

Main Objective: The aim of this prospective dose finding study is to estimate the minmal effective volume (ED95) for lidocaine 1.0% for filling the adductor canal when placing an adductor canal block. We will apply the Continual Reassesment 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. ;Secondary Objective: Secondary objectives are to investigate the effect on volume on spread to the femoral tiangle, muscle strength and sensory block.;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: Evaluated using MRI performed 15 minutes post block

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Secondary

Measure	Time frame
Secondary end point(s): • To investigate the effect of volume on proximal spread to the femoral triangle, evaluated as a binary outcome using MRI. • To investigate the effect of volume on quadriceps muscle strength, assessed as maximum voluntary isometric contraction (MVIC) 1 hour post block and evaluated as a binary outcome (redcution by more or less than 25%). • To investigate the effect of volume on sensory block assessed by pin-prick in the saphenous innervation area and in the popliteal fossa. • 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. ;Timepoint(s) of evaluation of this end point: Proximal spread will be avaluated using MRI performed at 15 minutes post block. Other secondary endpoints will be assessed at 1 h post block.	—

Measure

Time frame

Secondary end point(s): • To investigate the effect of volume on proximal spread to the femoral triangle, evaluated as a binary outcome using MRI. • To investigate the effect of volume on quadriceps muscle strength, assessed as maximum voluntary isometric contraction (MVIC) 1 hour post block and evaluated as a binary outcome (redcution by more or less than 25%). • To investigate the effect of volume on sensory block assessed by pin-prick in the saphenous innervation area and in the popliteal fossa. • 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. ;Timepoint(s) of evaluation of this end point: Proximal spread will be avaluated using MRI performed at 15 minutes post block. Other secondary endpoints will be assessed at 1 h post block.

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Countries

Denmark

Contacts

Public ContactClinical Trials Information

Professor Jørgen B. Dahl

pia.therese.jaeger@regionh.dk004535453478

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026