NCT02266732

Brief Summary

The traditional model of localizing a nerve for blockade is using a peripheral nerve stimulator, PNS. Recent advances in UltraSound technology has allowed UltraSound to guide nerve blockade. However despite excellent visualization nerve block success has not significantly improved. I aim to show that this is because the PNS stimulation of a nerve is more than a proximity response as thought but a correct fascial plane response and hence the high success rate of this blind approach.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable

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

May 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
Last Updated

February 23, 2015

Status Verified

February 1, 2015

Enrollment Period

1 month

First QC Date

October 3, 2014

Last Update Submit

February 19, 2015

Conditions

Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

  • Nerve stimulation resulting in muscle contraction or not

    Whether the nerve is successfully stimulated, resulting in muscle contraction, or not when the needle is on the wrong side of the fascial layer.

    Five minutes

Study Arms (2)

Interscalene block

OTHER
Device: Stimuplex HNS 12

Femoral block

OTHER
Device: Stimuplex HNS 12

Interventions

Stimuplex HNS 12DEVICE
Also known as: Peripheral nerve stimulator for nerve location
Femoral blockInterscalene block

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1 to 3 patients for any shoulder surgery or unilateral ACL knee surgery

You may not qualify if:

  • Refusal to consent
  • Allergy to Chirocaine local anaesthetic
  • Pace maker in situ
  • Sepsis at site of regional block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2014

First Posted

October 17, 2014

Study Start

May 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

February 23, 2015

Record last verified: 2015-02