Local infiltration analgesia (LIA) a multimodal pain management strategy in total knee arthroplasty.This study will investigate the effect of LIA on postoperative pain, opiod consumption, length of hospital stay and adverse effects.By downscaling the LIA it's hypotised there will be less adverse effects and no differences in other endpoints.
Conditions
Interventions
Trade Name: Ropivacaine HCl Fresenius Kabi
Product Name: Ropivacaine
Product Code: N01BB09
Pharmaceutical Form: Concentrate and solvent for solution for injection
CAS Number: 132112-35-7
Current Spons
Sponsors
Reinier de Graaf Groep
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
Exclusion criteria: • age III • moderate or severe cardiac disease, bronchial asthma • allergy against Ropivacain, Gabapentin • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Optimizing the amount of Ropivacain and Gabapentin, used for local infiltration (LIA) during TKA procedures by measuring the outcomes of pain (by using the 100 mm Visual Analogue Scale (VAS), adverse effects, length of hospital stay, cumulative pain medication consumption and wound leakage.;Secondary Objective: not applicable;Primary end point(s): - Pain scores , measured with VAS at day 1 at multiple moments: 1, 4 and 8 hours after operation in rest, and while and direct after mobilization starting at 4-6 hours after operation. At day 2 until the day of discharge at two moments. - Adverse effects (headache, nausea, vomiting, dizziness and sedation) - Cumulative consumption of opioid medication and pain medication. - Length of Hospital Stay by amount of nights and number of hours between operation and discharge. - Woundleakage in five point scale (none - severe);Timepoint(s) of evaluation of this end point: - VAS: 1,4,8 hours after operation in rest and direct after mobilization at 4-6 hours after operation. At day 2 until discharge at 2 standardized moments: morning and afternoon. - Adverse effects at the same moments - Cumulative consumption of opioid medication and pain medication during admission in hospital. - Woundleakage at 2 standardisd moments in morning and afternoon. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Orthopaedics
Reinier de Graaf Groep
Outcome results
None listed