NCT01973699

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed
Last Updated

January 1, 2016

Status Verified

December 1, 2015

Enrollment Period

5 months

First QC Date

October 25, 2013

Last Update Submit

December 31, 2015

Conditions

Visualization in Shoulder Arthroscopy

Keywords

shoulder arthroscopy, epinephrine, visualization

Outcome Measures

Primary Outcomes (1)

  • Visualization

    surgeon determined visualization during shoulder arthroscopy as judged by a VAS

    November 1, 2012- April 1, 2013 (5 months)

Secondary Outcomes (2)

  • Fluid Use

    November 1, 2012-April 1, 2013 (5 months)

  • Operative time

    November 1, 2012-April 1, 2013 (5 months)

Study Arms (2)

With Epinephrine

PLACEBO COMPARATOR

Patients undergoing shoulder arthroscopy with epinephrine in their irrigation as standardly performed

Other: visualization in shoulder arthroscopy

Without Epinephrine

EXPERIMENTAL

Patients undergoing shoulder arthroscopy without epinephrine in their irrigation fluid as typically done

Other: visualization in shoulder arthroscopy

Interventions

visualization in shoulder arthroscopyOTHER

Evaluating the effect of performing shoulder arthroscopy with and without epinephrine on visualization

With EpinephrineWithout Epinephrine

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients requiring shoulder arthroscopy

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke's University Hospital

Bethlehem, Pennsylvania, 18015, United States

Location

Study Officials

  • Gregory F Carolan, MD

    St. Luke's University Hospital and Health Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2013

First Posted

October 31, 2013

Study Start

November 1, 2012

Primary Completion

April 1, 2013

Study Completion

August 1, 2013

Last Updated

January 1, 2016

Record last verified: 2015-12

Locations

US(1)