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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

Tracking Information
First Submitted Date  ICMJE October 25, 2013
First Posted Date  ICMJE October 31, 2013
Last Update Posted Date January 1, 2016
Study Start Date  ICMJE November 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2013)
Visualization [ Time Frame: November 1, 2012- April 1, 2013 (5 months) ]
surgeon determined visualization during shoulder arthroscopy as judged by a VAS
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01973699 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2013)
  • Fluid Use [ Time Frame: November 1, 2012-April 1, 2013 (5 months) ]
    fluid used during arthroscopy
  • Operative time [ Time Frame: November 1, 2012-April 1, 2013 (5 months) ]
    operative time
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Visualization in Shoulder Arthroscopy With and Without Epinephrine
Official Title  ICMJE Surgeon Determined Visualization in Shoulder Arthroscopy: A Randomized, Blinded, Controlled Trial Comparing Irrigation Fluid With and Without Epinephrine
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Visualization in Shoulder Arthroscopy
Intervention  ICMJE Other: visualization in shoulder arthroscopy
Evaluating the effect of performing shoulder arthroscopy with and without epinephrine on visualization
Study Arms  ICMJE
  • Placebo Comparator: With Epinephrine
    Patients undergoing shoulder arthroscopy with epinephrine in their irrigation as standardly performed
    Intervention: Other: visualization in shoulder arthroscopy
  • Experimental: Without Epinephrine
    Patients undergoing shoulder arthroscopy without epinephrine in their irrigation fluid as typically done
    Intervention: Other: visualization in shoulder arthroscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2013)
83
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

All patients requiring shoulder arthroscopy

Exclusion Criteria:

none

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01973699
Other Study ID Numbers  ICMJE SLHN 2012-61
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Luke's Hospital, Pennsylvania
Study Sponsor  ICMJE St. Luke's Hospital, Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gregory F Carolan, MD St. Luke's University Hospital and Health Network
PRS Account St. Luke's Hospital, Pennsylvania
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP