Optimal Location of Local Anesthetic Injection for Ultras... | NCT01877330

Studies
Optimal Location of Local Anesthetic Injection for Ultrasound Guided Interscalene Block

NCT01877330

Sponsor

University of California, San Francisco

Status

Completed

Last Update Posted

Mar 19, 2020Actual

Enrollment

208Actual

Phase

Not Applicable

Conditions

Shoulder Arthroscopy
Ultrasound-guided Interscalene Nerve Block

Interventions

Interscalene block for shoulder arthroscopy

Countries

United States

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

Mar 2020

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

Jan 2013

Primary Completion Date

Mar 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Dec 12, 2012

First Submission Date that Met QC Criteria

Jun 12, 2013

First Posted Date

Jun 13, 2013Estimated

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

Mar 17, 2020

Last Update Posted Date

Mar 19, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a prospective randomized clinical trial to determine where is the optimal location for local anesthetic injection for ultrasound guided interscalene nerve blocks. The investigators are investigating if local anesthetic deposited between the nerve roots is more effective than local anesthetic deposited in the interscalene groove.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

208Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Injection in interscalene groove	Active Comparator	Patients undergoing shoulder arthroscopy will have an interscalene nerve block by injection of ropivacaine in the interscalene groove anterior and posterior to the brachial plexus nerves.	Procedure: Interscalene block for shoulder arthroscopy
Injection between nerve roots	Active Comparator	Patients undergoing shoulder arthroscopy will have an interscalene nerve block by injection of ropivacaine in the interscalene groove inbetween the C5 and C6 nerve roots.	Procedure: Interscalene block for shoulder arthroscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interscalene block for shoulder arthroscopy	Procedure		Injection between nerve roots Injection in interscalene groove

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Onset of motor blockade	Time to loss of shoulder abduction.	1 hour from time of injection

Secondary Outcomes

Measure	Description	Time Frame
Patient Satisfaction Score		24 hours
Opioid consumption	Opioid consumption - perioperative and post discharge	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I-II patients who are 18 years and older and who are scheduled for shoulder arthroscopy are eligible for enrollment provided they do not have any of the following exclusion criteria.

Exclusion Criteria:

chronic pain
high preoperative opioid requirement
age < 18 years old
non-English speaking
contraindication to regional anesthesia (allergy to local anesthetics, coagulopathy, severe thrombocytopenia, pre-existing neuropathy in operative limb, infection at puncture site)
need for postoperative nerve function monitoring
patient refusal
dementia
pulmonary disease or low baseline oxygen saturation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pedram Aleshi, MD	University of California, San Francisco	Principal Investigator
Monica W Harbell, MD	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCSF Orthopedic Institute		San Francisco	California	94158	United States