Lornoxicam Versus Etoricoxib in Postoperative Pain After Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-03-31

Brief Summary

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The purpose of this study is to assess efficacy and safety of lornoxicam compared with that of etoricoxib after total knee replacement.

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Detailed Description

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Total primary knee arthroplasty (TKA) remains a model of severe pain for major orthopedic surgery. The concept of multimodal analgesia for the postoperative pain therapy is a routine in many hospitals but the question is still under debate about the ideal combination between techniques and drugs regarding early mobilization and low risk of complications.

After obtaining Ethical Committee approval and informed consent, 110 patients American Society of Anesthesiologists score (ASA ) I-II undergoing knee replacement under spinal anesthesia were randomized to receive postoperative either lornoxicam (8 mg per os (PO) /12 hours (h) for 48 h) or etoricoxib (120mg PO/24 h for 48 h) both administered in the postoperative care unit, at the end of surgery.

The groups received postoperative analgesia when Numeric Rating Scale (NRS) over 3 with IV Perfalgan in fixed dose 1g every 8 h and morphine (loading dose 0,1mg/kg and titration until NRS under 3, followed by subcutaneous (SC) administration of ½ of the total loading dose on demand for the following 48 h).The lornoxicam group received gastric protection with IV pantoprazole.

The effectiveness was evaluated by the time from the initiation of spinal anesthesia until the first analgesic dose at NRS over 3, the total amount of morphine in the first 24 and 48 h postoperative, the side effects and necessary amount of adjuvant medication.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GROUP LORNOXICAM

Immediately in postoperative care unit patients received lornoxicam 8 mg PO/12 hours for 48 hours

Group Type EXPERIMENTAL

Lornoxicam

Intervention Type DRUG

At the end of surgery patients in group LORNOXICAM received one pill of 8 mg lornoxicam every 12 hours in the surgery day and first postoperative day.

GROUP ETORICOXIB

Immediately in postoperative care unit patients received etoricoxib 120 mg PO and another pill at 24 hours.

Group Type ACTIVE_COMPARATOR

Etoricoxib

Intervention Type DRUG

At the end of surgery patients in the ETORICOXIB group received one pill of 120 mg etoricoxib at the end of surgery and a second one after 24 hours. This group also received placebo pills at 12 h, between the active pills.

Interventions

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Lornoxicam

At the end of surgery patients in group LORNOXICAM received one pill of 8 mg lornoxicam every 12 hours in the surgery day and first postoperative day.

Intervention Type DRUG

Etoricoxib

At the end of surgery patients in the ETORICOXIB group received one pill of 120 mg etoricoxib at the end of surgery and a second one after 24 hours. This group also received placebo pills at 12 h, between the active pills.

Intervention Type DRUG

Other Intervention Names

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XEFO RAPID XEFO Arcoxia Tauxib

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* history of asthma
* peptic ulcer
* severe hepatic or renal dysfunction
* neuropathies
* bleeding disorders
* uncooperative
* drugs abuse
* sensibility to the drugs used
* 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No