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Visualization in Shoulder Arthroscopy With and Without Epinephrine

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ClinicalTrials.gov Identifier: NCT01973699
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : January 1, 2016
Sponsor:
Information provided by (Responsible Party):
St. Luke's Hospital, Pennsylvania

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Visualization in Shoulder Arthroscopy Other: visualization in shoulder arthroscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Surgeon Determined Visualization in Shoulder Arthroscopy: A Randomized, Blinded, Controlled Trial Comparing Irrigation Fluid With and Without Epinephrine
Study Start Date : November 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : August 2013


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




Primary Outcome Measures :
  1. Visualization [ Time Frame: November 1, 2012- April 1, 2013 (5 months) ]
    surgeon determined visualization during shoulder arthroscopy as judged by a VAS


Secondary Outcome Measures :
  1. Fluid Use [ Time Frame: November 1, 2012-April 1, 2013 (5 months) ]
    fluid used during arthroscopy

  2. Operative time [ Time Frame: November 1, 2012-April 1, 2013 (5 months) ]
    operative time



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All patients requiring shoulder arthroscopy

Exclusion Criteria:

none


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973699


Locations
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United States, Pennsylvania
St. Luke's University Hospital
Bethlehem, Pennsylvania, United States, 18015
Sponsors and Collaborators
St. Luke's Hospital, Pennsylvania
Investigators
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Principal Investigator: Gregory F Carolan, MD St. Luke's University Hospital and Health Network

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Responsible Party: St. Luke's Hospital, Pennsylvania
ClinicalTrials.gov Identifier: NCT01973699     History of Changes
Other Study ID Numbers: SLHN 2012-61
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: December 2015

Keywords provided by St. Luke's Hospital, Pennsylvania:
shoulder arthroscopy, epinephrine, visualization

Additional relevant MeSH terms:
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Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents