The researchquestions of this study are:1. What is the efficacy of treatment of postoperative pain after subacromial decompression with a subacromial catheter with ropivacaine versus placebo?2. What are the differences in costs per patient and in…
ID
Source
Brief title
Condition
- Bone disorders (excl congenital and fractures)
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain perception of the patient just after surgery and on certain moments
afterwards, set on a VAS score.
Secondary outcome
The amount of escape medication used by the patient and the calculated costs of
the postoperative pain management.
Background summary
Patients with subacromial impingement syndrome can be treated with a
subacromial decompression. This a surgery on the shoulder joint in which the
impingement will be corrected. After this surgery, patients experience a lot of
pain. This pain yields discomfort for the patients as well as the clinic. At
the moment NSAID and opioids are used for post-operative pain management, with
side effects and high costs. The relatively new painkiller ropivacaine has led
to research and new applications. There hasn't been a study in which the
application subacromial ropivacaine, with a catheter, after subacromial
decompression is examined.
Study objective
The researchquestions of this study are:
1. What is the efficacy of treatment of postoperative pain after subacromial
decompression with a subacromial catheter with ropivacaine versus placebo?
2. What are the differences in costs per patient and in escape medication
between the patients who had a subacromial catheter with ropivacaine versus
placebo after subacromial decompression?
Study design
RCT with 2 groups: continuous subacromial infusion with ropivacaine versus
placebo.
Study burden and risks
The extra burden for the patient is that he will have an intralesional
catheter, which will be removed 24 hours post-operative.
Geerdinksweg 141 / Postbus 546
7550 AM Hengelo
Nederland
Geerdinksweg 141 / Postbus 546
7550 AM Hengelo
Nederland
Listed location countries
Age
Inclusion criteria
Patients (18 years and older) with subacromial impingement syndrome who need a subacromial decompression by dr. C. van Doorn
Exclusion criteria
Significant damage at the affected shoulder or untreatable subacromial impingement
a history of injury at the affected shoulder
a history of surgery at the affected shoulder
a history of mastectomy at the affected side
a neuropathologic condition at the affected shoulder
chonic use of opioids
extraordinary risk-increasing factors, like morbid obesity
Parkinsons disease
pregnancy
contraindications for the used medications
disability which leads to an inability to describe pain and inability to fill in the VAS score.
not understand written and/or spoken Dutch
Design
Recruitment
Medical products/devices used
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 | EUCTR2010-022094-34-NL |
| CCMO | NL32285.044.10 |