To investigate the postoperative pain, compliance, satisfaction in the three different groups of postoperative analgesia and a possible interaction.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters will be painscores, satisfactionscores and compliance
of medication.
Secondary outcome
not applicable
Background summary
The hypothesis is that by decreasing the number of tablets necessary for a
satisfactory pain relief, in patients after arthroscopic menisectomy, the
compliance wil be better and therefore the postoperative analgesia will be at
least the same but hopefully better.
Study objective
To investigate the postoperative pain, compliance, satisfaction in the three
different groups of postoperative analgesia and a possible interaction.
Study design
prospective randomised study
Intervention
Intervention:
In this study patients will be divided in three groups,
group 1. will take 4xdd paracetamol 1 gram, 3xdd diclofenac 50 mg (total 11
tablets per day), if necessary tramal 50 mg max 4xdd (total max 15 tablets per
day)
group 2. will take 4xdd paracetamol 1 gram, 1xdd arcoxia 90 mg (total 9 tablets
per day), if necessary tramal 50 mg max 4xdd (total max 13 tablets per day)
and group 3. will take 4xdd 1 tablet zaldiar (=325 mg paracetamol + 37,5 mg
tramal) (total 4 tablets per day), if necessary zaldiar 4 dd 1 tablet extra
(total max 8 tablets per day)
Study burden and risks
Nature and extent of the burden and risk with participation:
- All patients, who have to undergo a meniscectomy, have to visit the
preoperative screening unit for information and informed consent.
- All included patients have to keep up with a diary for three days.
- Patients have to return all the medication they have not taken.
Dr. H. van der Hoffplein 1
6162BG Sittard-Geleen
NL
Dr. H. van der Hoffplein 1
6162BG Sittard-Geleen
NL
Listed location countries
Age
Inclusion criteria
(Pre)inclusion criteria:
- arthroscopic menisectomy in outdoor patients
- age between 18 and 65 years
- spinal anesthesia during surgery
- capable of keeping up with a data sheet at home
- informed consent
Exclusion criteria
exclusion criteria:
- pregnancy
- extensive damage to the cartilage of the kneejoint
- regular use of opiates and NSAID at home
- stomach complaints after using NSAID
- allergic to the medication
- taking anticoagulant medication (coumarins, clopidogrel, aspirin)
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 | EUCTR2009-016497-32-NL |
| CCMO | NL30083.096.09 |