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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02287142
Other study ID # IRB 14013
Secondary ID
Status Completed
Phase N/A
First received November 5, 2014
Last updated January 31, 2017
Start date October 2014
Est. completion date November 2016

Study information

Verified date January 2017
Source Benaroya Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 189
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- 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

Study Design


Intervention

Procedure:
Brachial plexus nerve block
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.

Locations

Country Name City State
United States Virginia Mason Medical Center Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Benaroya Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain NRS Pain Scale Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
Secondary Lung function Vital Capacity, Spirometry Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
Secondary Sensory and Motor Function Sensory Dermatome assessment C4 - C8 to touch; Motor assessment of grip and biceps with dynamometer Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
Secondary Diaphragmatic excursion Ultrasound measuring the diaphragm movement in centimeters (cm) Same day, 1 hour after arrival in the post-anesthesia care unit after surgery
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