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NCT Number: NCT02534610

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

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

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foisor Orthopedics Clinical Hospital

Bucharest, 021382, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Etoricoxib

Drug

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

Other names: Arcoxia, Tauxib, Algix, Exxiv, Etozox

Placebo

Drug

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.

Other names: Sham pill

Primary outcomes

  1. Total morphine consumption

    Time frame: At 48 hour postoperative

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

Secondary outcomes

  1. Number of patients with side effects of drugs used

    Time frame: 48 hour postoperative

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

  2. Duration of analgesia

    Time frame: At 48 hours postoperative

    Time from spinal anesthesia until the first rescue morphine analgesia

Sponsors and collaborators

Lead sponsor

Foisor Orthopedics Clinical Hospital

Other

Registry information

Official study title

Is There Any Analgesic Benefit From Preoperative vs. Postoperative Etoricoxib Administration in Total Knee Arthroplasty?

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 27, 2015
Registry last updated
Aug 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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