Postoperative Complications, Postoperative Pain
Conditions
Keywords
total knee arthroplasty, postoperative pain, programmed intermittent bolus, Continuous femoral nerve block
Brief summary
This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty.
Detailed description
This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty. One group of patients will receive automated intermittent bolus, while the others will get a continuous infusion. In both cases, patients will be able to administer supplementary auto-bolus if required.
Interventions
DRUGRopivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode)
programmed intermittent bolus 5ml each one hour.
DRUGRopivacaine Hcl 0.2% Inj Bag 200Ml (CI mode)
continuous infusion 6ml/h
Sponsors
J P Lecoq
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* admitted for unilateral primary total knee arthroplasty.
Exclusion criteria
* ASA score \> 3 * BMI \> 40 * refusal of loco-regional technique. * psychiatric disease. * inability to understand/ use the Local anesthetic delivery pump. * local anesthetic allergy, * porphyry, * uncontrolled epilepsy, * severe cardiac arrhythmia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of unplanned analgesia interventions. | up to 72 hours after surgery | Composite criteria including the frequency of unplanned analgesia interventions administered by the patient, or paramedical and medical staff, and by extenstion the total amount of opioids (in milligrams equivalent morphine) and local anesthetics (in milligrams) received in post-operative period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| local anesthesia technique related complications | until catheter removal 48 hours after surgery | rate of complications including: hematoma, infection, catheter dislodgement or breakage, allergic events. |
| Pain difference | up to 72 hours after surgery | Pain difference accessed by Numeric Pain Rating Scale (0-10), twice a day, at rest and on movement. |
| Motor block frequency | up to 72 hours after surgery | Accessed by physiotherapist twice a day, by testing the Quadriceps muscle. |
| Mobilization quality during physiotherapy sessions. | up to 72 hours after surgery | accessed by physiotherapist, ability to walk with or without help, take stairs, and flex and extend knee (comparatively to the opposite knee). |
Countries
Belgium
Outcome results
None listed