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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Etoricoxib; Drug: Placebo

• Registration Number: NCT02534610
• Lead Sponsor: Foisor Orthopedics Clinical Hospital

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Status Verified: 2015-08
• Study First Submitted: 2015-08-20
• Study First Submitted QC: 2015-08-26
• Last Update Submitted: 2015-08-26
• Study First Posted: 2015-08-27
• Last Update Posted: 2015-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• ASA I-III
• weight (kilos) over 40 kg
• height (centimeters) over 155 cm
• non-anemic
• indication for primary TKA (total knee arthroplasty)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group ETORICOXIB PREOP	Placebo	Preoperative (1 h) per os (PO) 120 mg Etoricoxib (Arcoxia) and 1 placebo pill PO at the end of surgery.
Group ETORICOXIB POSTOP	Placebo	Preoperative (1 h) 1 placebo pill PO and 120 mg Etoricoxib PO at the end of surgery (Arcoxia).
Group PLACEBO	Placebo	1 placebo pill PO 1 h preoperative and 1 placebo pill PO postoperative at the end of surgery.
Group ETORICOXIB PREOP	Etoricoxib	Preoperative (1 h) per os (PO) 120 mg Etoricoxib (Arcoxia) and 1 placebo pill PO at the end of surgery.
Group ETORICOXIB POSTOP	Etoricoxib	Preoperative (1 h) 1 placebo pill PO and 120 mg Etoricoxib PO at the end of surgery (Arcoxia).

Primary Outcome Measures

Name	Time	Method
Total morphine consumption	At 48 hour postoperative	Amount of IV and subcutaneous (SC) morphine (mg) required to reach NRS under 3

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Foisor Orthopedics Clinical Hospital; 🇷🇴 Bucharest, Romania