Postoperative Pain
Conditions
Keywords
preemptive, postoperative pain, etoricoxib
Brief summary
Evaluation of the efficacy of preemptive versus postoperative administration of etoricoxib in total knee arthroplasty (TKA).
Detailed description
The investigators conducted a prospective randomized controlled study in 165 patients American Society of Anesthesiologists (ASA) score I-III scheduled for primary TKA, divided in 3 groups: group A (Etoricoxib 120 mg orally one hour before surgery), group B (Etoricoxib 120 mg orally at the end of surgery) and group C placebo. Surgery has been performed under spinal anesthesia. All groups received postoperative analgesia when Numeric Rating Scale (NRS) over 3 with intravenous (IV) Perfalgan and morphine on demand for the following 48 h. The effectiveness was evaluated by the time from the initiation of spinal anesthesia until the first analgesic dose at NRS \> 3, the total amount of morphine in the first 24 and 48 hours postoperative, the side effects and necessary amount of adjuvant medication.
Interventions
DRUGEtoricoxib
120 mg etoricoxib PO administered 1 h preoperative for group A; group B received 120 mg etoricoxib PO at the end of the surgery.
DRUGPlacebo
Group A received 1 sham pill PO at the end of the surgery; group B received 1 sham pill PO 1 h preoperative and group C received sham pill PO 1 h preoperative and 1 sham pill PO at the end of the surgery.
Sponsors
Foisor Orthopedics Clinical Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* ASA I-III * weight (kilos) over 40 kg * height (centimeters) over 155 cm * non-anemic * indication for primary TKA (total knee arthroplasty)
Exclusion criteria
* history of asthma * peptic ulcer * severe hepatic or renal dysfunction * neuropathies * bleeding disorders * uncooperative * drug abuse * sensibility to etoricoxib * paracetamol or morphine * long acting nonsteroidal antiinflammatory drugs (NSAID) in the last 4 days preoperative * cerebrovascular and peripheric vascular disease * arterial hypertension (HTA) not adequately controlled * congestive heart failure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine consumption | At 48 hour postoperative | Amount of IV and subcutaneous (SC) morphine (mg) required to reach NRS under 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with side effects of drugs used | 48 hour postoperative | number of patients with postoperative nausea and vomiting (PONV) or respiratory depression or gastric complaint or allergic reactions |
| Duration of analgesia | At 48 hours postoperative | Time from spinal anesthesia until the first rescue morphine analgesia |
Countries
Romania
Outcome results
None listed