Lornoxicam Versus Etoricoxib in Postoperative Pain After Total Knee Arthroplasty

Phase 3

Completed

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

• Registration Number: NCT02750917
• Lead Sponsor: Foisor Orthopedics Clinical Hospital

Brief Summary

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

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 Timeline

• Study Start: 2014-09
• Primary Completion: 2015-01
• Study Completion: 2015-03
• Status Verified: 2016-02
• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-04-25
• Last Update Submitted: 2016-04-25
• Study First Posted: 2016-04-26
• Last Update Posted: 2016-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GROUP LORNOXICAM	Lornoxicam	Immediately in postoperative care unit patients received lornoxicam 8 mg PO/12 hours for 48 hours
GROUP ETORICOXIB	Etoricoxib	Immediately in postoperative care unit patients received etoricoxib 120 mg PO and another pill at 24 hours.

Primary Outcome Measures

Name	Time	Method
Total morphine consumption	At 48 hours 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	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