To determine whether the use of epinephrine saline irrigation in therapeutic shoulder arthroscopy with need for subacromial procedures should significantly increase clarity of the view.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in intra-operative clarity of the visual view between
epinephrine and placebo subjects in: Mean VAS score; the main study parameter
is a 2-point difference (20 %).
Secondary outcome
Difference in mean blood pressure, potential cardiovasculair adverse reactions
and serum epinephrine levels.
Background summary
Arthroscopy of the shoulder is increasingly developing due to the rise of
number of patients to treat and the increasing possibility to use arthroscopy
for diagnostics and treatment.
To perform an arthroscopic operation safely an optimal view is essential. The
most common factor impairing the clarity of the visual view is intra-articular
and or subacromial bleeding. To achieve this optimal view previous studies used
techniques that directly aimed at controlling the bleeding, using thermal
electrocauthery devices and pressurized irrigation systems. These techniques
increase the intra-articular joint space and the fluid flow removes debris and
blood. However, optimal view cannot always be acquired.
Anecdotic observations in clinical practice, at our institute and in literature
suggest that the use of epinephrine added to the irrigation fluid used in knee
and shoulder arthroscopy minimizes intra-operative bleeding hence increasing
the view. Information about the effectiveness of adding epinephrine to
irrigation fluid in subjects undergoing shoulder arthroscopy with the need for
subacromial procedures is scarce.
(seen background protocol 1.0)
Study objective
To determine whether the use of epinephrine saline irrigation in therapeutic
shoulder arthroscopy with need for subacromial procedures should significantly
increase clarity of the view.
Study design
Prospective, randomized, double-blinded, placebo-controlled study
Study burden and risks
A good intra-operative view is essential in performing arthroscopic shoulder
surgery. Therefore this study provides an excellent model to study differences
in visibility. Ultimately this may lead to better identification and treatment
of subjects with shoulder pathology.
The burden for the participants is limited to a total of three venous blood
samples taken before and after the surgery using a already placed IV. To assess
the decrease in bleeding epinephrine is added to the irrigation fluid. The
risks associated with this drug exposure are, in this type of use rare (see
background). Possible adverse reactions include: palpitations, tachycardia,
arrhythmia, anxiety, headache, tremor, hypertension and acute pulmonary edema.
Sportlaan 600
Den Haag 2566 MJ
NL
Sportlaan 600
Den Haag 2566 MJ
NL
Listed location countries
Age
Inclusion criteria
- Patients that are willing and able to participate in the study protocol
- Patients in need of arthroscopic shoulder surgery based on; a Bankart- or SLAP-lesion, a rotator cuff lesion, an impingement syndrome and or AC-joint pathology.
Exclusion criteria
- patients with known cardiac diseases/ arrhithmia
- age under eighteen years
- language barrier
- mental disabilities
- Uncontrolled hypertension (* 180/110)
- Hypokalaemia
- Atopic asthma
- Constitutional allergy
- Sulphite allergy
- increased surgical risk( ASA >3)
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-016696-30-NL |
| CCMO | NL30185.098.09 |