Visualization in Shoulder Arthroscopy With and Without Epinephrine

NCT ID: NCT01973699

Last Updated: 2016-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-08-31

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.

Conditions

Visualization in Shoulder Arthroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

With Epinephrine

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

Group Type: PLACEBO_COMPARATOR

visualization in shoulder arthroscopy

Intervention Type: OTHER

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

Without Epinephrine

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

Group Type: EXPERIMENTAL

visualization in shoulder arthroscopy

Intervention Type: OTHER

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

Interventions

visualization in shoulder arthroscopy

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

All patients requiring shoulder arthroscopy

Exclusion Criteria

none

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Luke's Hospital, Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory F Carolan, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's University Hospital and Health Network

Locations

St. Luke's University Hospital

Bethlehem, Pennsylvania, United States

Countries

United States

Other Identifiers

SLHN 2012-61

Identifier Type: -

Identifier Source: org_study_id