Visualization in Shoulder Arthroscopy With and Without Epinephrine

Surgeon Determined Visualization in Shoulder Arthroscopy: A Randomized, Blinded, Controlled Trial Comparing Irrigation Fluid With and Without Epinephrine

Adequate visualization during shoulder arthroscopy is of great importance for the procedure to be efficiently and effectively performed. The use of dilute epinephrine in irrigation fluid has been historically utilized to help with visualization. Given the potential safety issues documented in the literature related to epinephrine use, as well as the significant improvements in technique and instrumentation over the last decade, the need for this additive should be reexamined. The objective of the current study was to compare surgeon determined visualization in shoulder arthroscopy using irrigation fluid with and without epinephrine.

Study Overview

• Status: Completed
• Conditions: Visualization in Shoulder Arthroscopy
• Intervention / Treatment: Other: visualization in shoulder arthroscopy

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All patients requiring shoulder arthroscopy

Exclusion Criteria:

none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: With Epinephrine; Patients undergoing shoulder arthroscopy with epinephrine in their irrigation as standardly performed	Other: visualization in shoulder arthroscopy; Evaluating the effect of performing shoulder arthroscopy with and without epinephrine on visualization
Experimental: Without Epinephrine; Patients undergoing shoulder arthroscopy without epinephrine in their irrigation fluid as typically done	Other: visualization in shoulder arthroscopy; Evaluating the effect of performing shoulder arthroscopy with and without epinephrine on visualization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visualization	surgeon determined visualization during shoulder arthroscopy as judged by a VAS	November 1, 2012- April 1, 2013 (5 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluid Use	fluid used during arthroscopy	November 1, 2012-April 1, 2013 (5 months)
Operative time	operative time	November 1, 2012-April 1, 2013 (5 months)

Collaborators and Investigators

• Sponsor: St. Luke's Hospital, Pennsylvania
• Investigators: Principal Investigator: Gregory F Carolan, MD, St. Luke's University Hospital and Health Network

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: October 25, 2013
• First Submitted That Met QC Criteria: October 30, 2013
• First Posted (Estimate): October 31, 2013

Study Record Updates

• Last Update Posted (Estimate): January 1, 2016
• Last Update Submitted That Met QC Criteria: December 31, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: shoulder arthroscopy, epinephrine, visualization
• Other Study ID Numbers: SLHN 2012-61