Lornoxicam Versus Etoricoxib in Postoperative Pain After Total Knee Arthroplasty

NCT02750917 | Completed Phase 3 DMC

• 1 other identifier: ID ANALG-002-13
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Postoperative Pain

Keywords

postoperative pain; lornoxicam; etoricoxib; total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  Amount of IV and subcutaneous (SC) morphine (mg) required to reach NRS under 3

  At 48 hours postoperative

Secondary Outcomes (2)

• Number of patients with side effects of drugs used

  At 48 hours postoperative

• Duration of analgesia

  At 48 hours postoperative

Study Arms (2)

GROUP LORNOXICAM

EXPERIMENTAL

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

Drug: Lornoxicam

GROUP ETORICOXIB

ACTIVE COMPARATOR

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

Drug: Etoricoxib

Interventions

Lornoxicam 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.

Also known as: XEFO RAPID, XEFO

GROUP LORNOXICAM

Etoricoxib 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.

Also known as: Arcoxia, Tauxib

GROUP ETORICOXIB

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Foisor Orthopedics Clinical Hospital: lead

Related Publications (6)

• 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.

  PMID: 23428763 BACKGROUND

• 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.

  PMID: 10434236 BACKGROUND

• 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.

  PMID: 17953792 BACKGROUND

• 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.

  PMID: 24481580 RESULT

• 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.

  PMID: 8951927 RESULT

• 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.

  PMID: 19606021 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

lornoxicam; Etoricoxib

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ioan Cristian Stoica, Prof

  Foisor Orthopedics Clinical Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: April 26, 2016
• Study Start: September 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 26, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share