Distance for Interscalene Block | NCT01568463

Studies
Distance for Interscalene Block

NCT01568463

Sponsor

University Health Network, Toronto

Status

Completed

Last Update Posted

Jan 10, 2018Actual

Enrollment

25Actual

Phase

Not provided

Conditions

Regional Anesthesia
Inter Scalene Block
Post Operative Analgesia

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012Actual

Primary Completion Date

Jan 24, 2013Actual

Completion Date

Mar 26, 2014Actual

First Submitted Date

Mar 6, 2012

First Submission Date that Met QC Criteria

Mar 30, 2012

First Posted Date

Apr 2, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2018

Last Update Posted Date

Jan 10, 2018Actual

Description Module

Brief Summary

Patients experience significant postoperative pain following shoulder surgery, Single shot interscalene block is used in ambulatory shoulder surgery for its advantages that include significant reduction in acute pain and analgesic requirements, prolonged time to first analgesic request, decreased incidence of nausea, as well as earlier hospital discharge.The process of nerve block requires several needle passes, with each of them being at risk of causing nerve injury either by direct trauma or intraneural injection even with the use of the ultrasound. These facts raised concerns and several authors stated that maybe the anesthesiologists should be more careful, keep a safe distance from the nerve, and inject the local anesthetics into fascial planes containing the nerve and not attempt to place the needle in close proximity to the nerve. This study is designed to determine the maximal effective distance away from the nerve for the injection to be effective.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Success of the inter-scalene block at 20 minutes after injection at a specific distance of the needle tip from the outer sheeth of the nerve		20 mins

Secondary Outcomes

Measure	Description	Time Frame
The onset time of sensory and motor block		the block success will be assessed for each patient every 5 min for 20 mins in the block room beginning when the needle exits the skin
The proportion of inadequate and failed blocks.		the block success will be assessed for each patient every 5 min for 20 mins in the block room beginning when the needle exits the skin

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA physical status I-III
18-85 years of age, inclusive
surgery less than 3 hours

Exclusion Criteria:

contraindications to brachial plexus block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
existing neurological deficit in the area to be blocked
pregnancy
history of neck surgery or radiotherapy
severe respiratory disease
inability to understand the informed consent and demands of the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing shoulder surgery (shoulder arthroscopy or open shoulder surgery)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Brull, MD, FRCPC	University of Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Toronto Western Hospital		Toronto	Ontario	M5T 2S8	Canada