The aim of the study was to assess whether administration of gabapentin and
methylprednisolone as "pre-emptive analgesia" in a group of patients above 65 years of age
would be effective in complex pain management therapy following total knee arthroplasty
(TKA).170 patients operated on due to unilateral TKA will be double-blinded randomized into
two groups: the study and the controls. Exclusion criteria are: clinical situation that 1/
restricted glucocorticoid administration: diabetes type 1 and 2, CRP levels above normal
values (≥5 mg/l), chronic steroid treatment, peptic ulcers treated in the past 30 days and
2/and the chronic pain in the course of gonarthrosis, high intensity requiring use opioids.
The participants of the study will be subjected to the standardized procedure of subarachnoid
anesthesia with subsequent unilateral femoral nerve block at the operated side, followed by
the surgical procedure - unilateral TKA. The study group will receive as "pre-emptive"
analgesia a single dose of 300 mg oral gabapentin and 125 mg intravenous methylprednisolone,
while the others placebo. Prior to anesthesia induction, the patients receive: anti-infection
prophylactics intravenous cephazolin 2.0 g, for hemostasis control - tranexamic acid 1.0 g,
an anti-emetic agent - ondansetron 8 mg. Fluid supply (crystalloids) will be standardized: 12
ml/kg in the first hour of surgery and 6 ml/kg in the following hours, packed red blood cells
if blood loss exceeded 600 ml and hemoglobin concentration <10g/l during the time of
operation. Pain management will be carried out based on the results of the NRS scales at
rest. Every 6 hours NRS will be checked and intravenous PCA (patient-controlled analgesia)
oxycodone hydrochloride, if pain was ≥4 points NRS or intravenous paracetamol, metamizole, if
the pain was 2 - 4 NRS points will be administered, all pain medications will be calculated
for 1 kg of body weight. In keeping with the ERAS (Enhanced Recovery After Surgery) protocol,
on the day of surgery the patients will receive orally fluids and meals, will be mobilized
and rehabilitated.
The study was approved by the institutional review board (nr 1072.6120.11.2020). Oral and
written informed consent to participate in the study will be collected from all participants
of the study. The statistical analysis of the groups will be performed to asess the
demographic dates, life parameters, general condition in keeping with the ASA (American
Society of Anesthesiology), POSSUM (Physiologic and Operative Severity Score for the
enUmeration of Mortality and Morbidity) score, total dose of analgesic medications
administered parenterally calculated for 1 kg of body mass in response to value of NRS at
rest on day 0, time of administration the first dose, and duration of peripheral nerve block.
On the day of surgery and on subsequent days, determinations will be made of glycemia levels
and inflammatory markers: C-reactive protein (CRP) and leukocytosis levels.
