Pain, Postoperative
Conditions
Interventions
This is a randomized, multicenter, prospective, double-blind clinical trial designed to compare the effect of genicular nerve block performed intraoperatively in total knee arthroplasty with conventio
Sponsors
São Paulo Secretaria de Saúde
São Paulo Secretaria de Saúde
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: patients over 18 years of age; diagnosed with primary gonarthrosis and disabling knee pain with a visual analog scale (vas) pain score of 7 or higher; unresponsive to conservative treatment and with a prior indication for total knee arthroplasty; able to use the pain assessment method and follow hospital discharge guidelines.
Exclusion criteria
Exclusion criteria: known allergy to the medications used in the protocol; cognitive impairment preventing the use of a smartphone and understanding the visual analog scale for pain (vas) and the informed consent form; history of previous surgeries on the affected knee; renal or hepatic insufficiency, coagulation disorders, sensory neuropathies, and prior regular use of opioids; loss to follow-up during the evaluation period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to evaluate the effectiveness of genicular nerve block performed during intraoperative total knee arthroplasty in reducing postoperative pain in the first 24 hours, using the visual analog scale (vas) as a measure of pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| To verify the effect of genicular nerve block on accelerating hospital discharge (up to 24 hours after the procedure), assessed by the date and time of discharge recorded by the auxiliary evaluators.;To assess the reduction in opioid consumption in the first three weeks after surgery, evaluated by opioid consumption records made by assistant researchers through telephone contacts every two days after the surgical procedure, up to three weeks after the procedure.;Analyze the gain in range of motion of the operated knee over the three postoperative weeks, every two days, through photos submitted with a pattern of maximum flexion and maximum extension of the knee.;To assess patient mobility and satisfaction levels three months after surgery. To perform a subgroup analysis considering patients with bilateral knee pain, diabetic patients, patients with fibromyalgia, and overweight patients. The assessment is done twenty-one days after the surgical procedure through self-reported patient satisfaction.;To investigate the incidence of possible complications associated with genicular nerve blocks, such as infections or local adverse effects, through self-reported complications in telephone contact every two days and follow-up visits. | — |
Countries
Brazil
Contacts
Public ContactFrederico Jana Neto
Conjunto Hospitalar Mandaqui
Outcome results
None listed