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

August 26, 2015 updated by: Munteanu Ana Maria, MD, PhD, Foisor Orthopedics Clinical Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania, 021382
        • Foisor Orthopedics Clinical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group ETORICOXIB PREOP
Preoperative (1 h) per os (PO) 120 mg Etoricoxib (Arcoxia) and 1 placebo pill PO at the end of surgery.
Drug: Etoricoxib
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
Drug: Placebo
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
Experimental: Group ETORICOXIB POSTOP
Preoperative (1 h) 1 placebo pill PO and 120 mg Etoricoxib PO at the end of surgery (Arcoxia).
Drug: Etoricoxib
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
Drug: Placebo
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
Placebo Comparator: Group PLACEBO
1 placebo pill PO 1 h preoperative and 1 placebo pill PO postoperative at the end of surgery.
Drug: Placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total morphine consumption
Time Frame: At 48 hour postoperative
Amount of IV and subcutaneous (SC) morphine (mg) required to reach NRS under 3
At 48 hour postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of analgesia
Time Frame: At 48 hours postoperative
Time from spinal anesthesia until the first rescue morphine analgesia
At 48 hours postoperative
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
48 hour postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foisor Orthopedics Clinical Hospital

Investigators

  • Principal Investigator: Munteanu Ana-Maria, MD, PhD, Foisor Orthopedics Clinical Hospital Bucharest
  • Study Director: Stoica I Cristian, MD, Prof., Foisor Orthopedics Clinical Hospital Bucharest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

August 20, 2015

First Submitted That Met QC Criteria

August 26, 2015

First Posted (Estimate)

August 27, 2015

Study Record Updates

Last Update Posted (Estimate)

August 27, 2015

Last Update Submitted That Met QC Criteria

August 26, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN010-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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