NCT02657603

Brief Summary

This is a single center, randomized, blinded trial in healthy volunteers. The volunteers will receive bilateral placement of the new catheter corresponding to the adductor canal. Each volunteer will have a catheter placed in the adductor canal in both legs. The catheters are randomized to be placed either in the long-axis or short-axis plane of the adductor canal. Both catheters will be injected with local analgesics (LA). Allocation will be blinded to the volunteer and the investigator assessing sensory function. The volunteers will be sent home with the catheter in situ and return the following day. Injection with LA is repeated and sensory function is tested again. Furthermore catheter position is determined with ultrasound during injection. If sensory function is not affected by injection of LA then the catheter is visualized with ultrasound and repositioned followed by a second injection of LA and subsequent assessment of sensory function

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 19, 2017

Status Verified

October 1, 2017

Enrollment Period

2 months

First QC Date

January 11, 2016

Last Update Submit

October 18, 2017

Conditions

Pain

Keywords

Peripheral Nerve Blocks

Outcome Measures

Primary Outcomes (1)

  • Loss of cold sensation

    Loss of cold sensation after injection of Lidocaine(LA)

    30 minutes after injection

Secondary Outcomes (5)

  • Discomfort during day 1

    1 day

  • Loss of cold sensation on day 2 - indicating correct position of the catheter on day 2

    1 day after insertion

  • Interrater agreement between 2 assessors whether catheter is within the adductor canal assessed by US video.

    1 day

  • Displacement distance

    1 day

  • Loss of cold sensation after repositioning if found to be displaced - Indicating successful repositioning

    1 day

Other Outcomes (3)

  • Procedure time

    1 hour

  • insertion attempts

    1 hour

  • Affected skin area

    1 hour

Study Arms (2)

LAX insertion of catheter

ACTIVE COMPARATOR

Lidocaine 10mg/ml, 15 ml injected into the adductor canal

Drug: LidocaineProcedure: LAX insertion of catheter

SAX insertion of catheter

ACTIVE COMPARATOR

Lidocaine 10mg/ml, 15 ml injected into the contralateral adductor canal

Drug: LidocaineProcedure: SAX insertion of catheter

Interventions

LidocaineDRUG

Lidocaine injected through the new Catheter (LAX)

Also known as: Lidocainehydrochlorid, Xylocaine
LAX insertion of catheter
LAX insertion of catheterPROCEDURE

ultra sound guided cather insertion in the long axis (LAX) of the adductor canal

LAX insertion of catheter
SAX insertion of catheterPROCEDURE

ultra sound guided cather insertion in the short axis (SAX) of the adductor canal

SAX insertion of catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female ≥18 years of age.
  • ASA classification ≤ II. (ASA physical status classification system)
  • Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

You may not qualify if:

  • Distance from skin to adductor canal above 4 cm
  • Previous or ongoing surgery, pain or other disability of the investigated region resulting in sensory or neurologic deficits in the investigated region.
  • Allergy to LA.
  • Pregnancy (all female participants will be tested for urine hCG), breastfeeding, or unwilling to practice birth control during participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

Related Links

MeSH Terms

Conditions

Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Tobias S Lyngeraa, MD

    Nordsjaellands Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head Of Research

Study Record Dates

First Submitted

January 11, 2016

First Posted

January 18, 2016

Study Start

January 1, 2016

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

October 19, 2017

Record last verified: 2017-10

Locations

DK(1)