Lornoxicam Versus Etoricoxib in Postoperative Pain After Total Knee Arthroplasty

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Lornoxicam; Drug: Etoricoxib

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with side effects of drugs used	Number of patients with postoperative nausea and vomiting (PONV) or respiratory depression or gastric complaint or allergic reactions	At 48 hours postoperative
Duration of analgesia	Time from spinal anesthesia until the first rescue morphine analgesia	At 48 hours postoperative

Collaborators and Investigators

• Sponsor: Foisor Orthopedics Clinical Hospital
• Investigators: Study Director: Ioan Cristian Stoica, Prof, Foisor Orthopedics Clinical Hospital

Publications and helpful links

General Publications

• Ersan O, Akkaya T, Arik E, Ates Y. Intra-articular levobupivacaine, lornoxicam and morphine analgesia after knee arthroscopy: a randomized, controlled trial. Acta Orthop Traumatol Turc. 2012;46(6):411-5.
• Staunstrup H, Ovesen J, Larsen UT, Elbaek K, Larsen U, Kroner K. Efficacy and tolerability of lornoxicam versus tramadol in postoperative pain. J Clin Pharmacol. 1999 Aug;39(8):834-41. doi: 10.1177/00912709922008362.
• Sener M, Yilmazer C, Yilmaz I, Caliskan E, Donmez A, Arslan G. Patient-controlled analgesia with lornoxicam vs. dipyrone for acute postoperative pain relief after septorhinoplasty: a prospective, randomized, double-blind, placebo-controlled study. Eur J Anaesthesiol. 2008 Mar;25(3):177-82. doi: 10.1017/S0265021507002827. Epub 2007 Oct 22.
• Sivrikoz N, Koltka K, Guresti E, Buget M, Senturk M, Ozyalcin S. Perioperative dexketoprofen or lornoxicam administration for pain management after major orthopedic surgery: a randomized, controlled study. Agri. 2014;26(1):23-8. doi: 10.5505/agri.2014.09821.
• Norholt SE, Sindet-Pedersen S, Larsen U, Bang U, Ingerslev J, Nielsen O, Hansen HJ, Ersboll AK. Pain control after dental surgery: a double-blind, randomised trial of lornoxicam versus morphine. Pain. 1996 Oct;67(2-3):335-43. doi: 10.1016/0304-3959(96)03126-0.
• Buvanendran A, Kroin JS. Multimodal analgesia for controlling acute postoperative pain. Curr Opin Anaesthesiol. 2009 Oct;22(5):588-93. doi: 10.1097/ACO.0b013e328330373a.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: April 25, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Estimate): April 26, 2016
• Last Update Submitted That Met QC Criteria: April 25, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: total knee arthroplasty; postoperative pain; etoricoxib; lornoxicam
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Etoricoxib; Lornoxicam
• Other Study ID Numbers: ID ANALG-002-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No