Analgesic Benefit of Preoperative vs. Postoperative Etoricoxib in Total Knee Arthroplasty

Foisor Orthopedics Clinical Hospital165 enrolled

Overview

Evaluation of the efficacy of preemptive versus postoperative administration of etoricoxib in total knee arthroplasty (TKA).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

165

Conditions

Postoperative Pain

Interventions

EtoricoxibDRUG

120 mg etoricoxib PO administered 1 h preoperative for group A; group B received 120 mg etoricoxib PO at the end of the surgery.

PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Foisor Orthopedics Clinical Hospital

Bucharest, Romania

Outcomes

Primary Outcomes

Total morphine consumption

Amount of IV and subcutaneous (SC) morphine (mg) required to reach NRS under 3

Time frame: At 48 hour postoperative

Secondary Outcomes

Number of patients with side effects of drugs used

number of patients with postoperative nausea and vomiting (PONV) or respiratory depression or gastric complaint or allergic reactions

Time frame: 48 hour postoperative

Duration of analgesia

Time from spinal anesthesia until the first rescue morphine analgesia

Time frame: At 48 hours postoperative

Data from ClinicalTrials.gov

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