Lornoxicam Versus Etoricoxib in Postoperative Pain After Total Knee Arthroplasty

Sponsor

Foisor Orthopedics Clinical Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02750917

Collaborator

(none)

120

Enrollment

Arms

5.9

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Lornoxicam Drug: Etoricoxib	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Comparative Study of Efficacy and Safety of Lornoxicam Versus Etoricoxib After Total Knee Arthroplasty

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GROUP LORNOXICAM Immediately in postoperative care unit patients received lornoxicam 8 mg PO/12 hours for 48 hours	Drug: 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. Other Names: XEFO RAPID XEFO
Active Comparator: GROUP ETORICOXIB Immediately in postoperative care unit patients received etoricoxib 120 mg PO and another pill at 24 hours.	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. Other Names: Arcoxia Tauxib

Arm

Intervention/Treatment

Experimental: GROUP LORNOXICAM

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

Drug: 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.

Other Names:

XEFO RAPID

XEFO

Active Comparator: GROUP ETORICOXIB

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

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.

Other Names:

Arcoxia

Tauxib

Outcome Measures

Primary Outcome Measures

Total morphine consumption [At 48 hours postoperative]
Amount of IV and subcutaneous (SC) morphine (mg) required to reach NRS under 3

Secondary Outcome Measures

Number of patients with side effects of drugs used [At 48 hours 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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