ocal infiltration anesthesia in total knee arthroplasty
Phase 2
Completed
- Conditions
- Pain after total knee arthroplasty10023213
- Registration Number
- NL-OMON39330
- Lead Sponsor
- Reinier de Graaf Groep
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 128
Inclusion Criteria
The hospital criteria and protocol for patients who are diagnosed for a total knee arthroplasty in the outpatients* clinic of the Orthopaedic Department of RdGG Hospital Delft
* Patients at least 18 years of age
* Scheduled for elective total knee arthroplasty
* ASA I-III
* Willing to participate
Exclusion Criteria
* age < 18
* ASA IV
* moderate or severe cardiac disease, bronchial asthma
* allergy against Ropivacain, Gabapentin, Epinephrin
* pregnancy
* severe psychiatric disease
* moderate to severe dementia, mentally retarded
* BMI > 40
* Abuse alcohol and drugs
* Chronic use of opioids
* Patients diagnosed Rheumatoid arthritis
* Revision TKA
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters are pain scores and adverse effects after TKA with<br /><br>LIA.<br /><br>- Pain score (VAS) at day 1 at multiple moments: 1, 4 and 8 hours after<br /><br>operation in rest, and while and direct after mobilization starting at 4-6<br /><br>hours after operation. At day 2 until the day of discharge at two standardized<br /><br>moments;<br /><br>- Adverse effects (headache, nausea, vomiting, dizziness and sedation)<br /><br>- Cumulative consumption of opioid medication and (rescue) pain medication.<br /><br>- Length of Hospital Stay by amount of nights and number of hours between<br /><br>operation and discharge.<br /><br>- Wound leakage using a five point scale.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable</p><br>