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

Foisor Orthopedics Clinical Hospital

Status: Completed

Conditions: Postoperative Pain

Treatments: Drug: Etoricoxib; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02534610

AN010-13

Details and patient eligibility

About

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

Full 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.

Enrollment: 165 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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165 participants in 3 patient groups, including a placebo group

Group ETORICOXIB PREOP

Experimental group

Description:

Preoperative (1 h) per os (PO) 120 mg Etoricoxib (Arcoxia) and 1 placebo pill PO at the end of surgery.

Treatment:

Drug: Placebo

Drug: Etoricoxib

Group ETORICOXIB POSTOP

Experimental group

Description:

Preoperative (1 h) 1 placebo pill PO and 120 mg Etoricoxib PO at the end of surgery (Arcoxia).

Treatment:

Drug: Placebo

Drug: Etoricoxib

Group PLACEBO

Placebo Comparator group

Description:

1 placebo pill PO 1 h preoperative and 1 placebo pill PO postoperative at the end of surgery.

Treatment:

Drug: Placebo