NCT02287142

Brief Summary

The aim of this study is to assess analgesic efficacy of a supraclavicular nerve block, suprascapular nerve block, or interscalene nerve block in a population undergoing shoulder arthroscopy with rotator cuff repair. The investigators hypothesize that subjects from all three arms will receive equal analgesia since these blocks are routinely performed to treat post-operative pain after shoulder surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
189

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 10, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 2, 2017

Status Verified

January 1, 2017

Enrollment Period

2.1 years

First QC Date

November 5, 2014

Last Update Submit

January 31, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain

    NRS Pain Scale

    Same day, 1 hour after arrival in the post-anesthesia care unit after surgery

Secondary Outcomes (3)

  • Lung function

    Same day, 1 hour after arrival in the post-anesthesia care unit after surgery

  • Sensory and Motor Function

    Same day, 1 hour after arrival in the post-anesthesia care unit after surgery

  • Diaphragmatic excursion

    Same day, 1 hour after arrival in the post-anesthesia care unit after surgery

Study Arms (3)

Interscalene

ACTIVE COMPARATOR

Single-shot Interscalene Nerve Block with ropivacaine 0.5%

Procedure: Brachial plexus nerve block

Supraclavicular

ACTIVE COMPARATOR

Single-shot Supraclavicular Nerve Block with ropivacaine 0.5%

Procedure: Brachial plexus nerve block

Suprascapular

ACTIVE COMPARATOR

Single-shot Suprascapular Nerve Block with ropivacaine 0.5%

Procedure: Brachial plexus nerve block

Interventions

All arms of the study comparing the three different blocks are receiving the same single injection bolus of ropivacaine 0.5% prior to surgery. We will then record and compare pain scores in PACU and opioid requirement.

InterscaleneSupraclavicularSuprascapular

Eligibility Criteria

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

You may qualify if:

  • Unilateral total shoulder arthroscopy for rotator cuff surgery ASA physical status I-III, \>18 years old, Non-pregnant, Consent to participate in the study

You may not qualify if:

  • Refusal to participate, \< 18 years old, Chronic opioid use, Localized infection, Pregnancy or lactating, Pre-existing coagulopathy, Allergy to ultrasound gel or local anesthetics, Diaphragmatic dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Pain, PostoperativePainPathologic Processes

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • David Auyong, MD

    Virginia Mason Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

November 5, 2014

First Posted

November 10, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

February 2, 2017

Record last verified: 2017-01

Locations