Lornoxicam Versus Etoricoxib in Postoperative Pain After Total Knee Arthroplasty

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02750917
• Other study ID #: ID ANALG-002-13
• Status: Completed
• Phase: Phase 3
• First received: February 18, 2016
• Last updated: April 25, 2016
• Start date: September 2014
• Est. completion date: March 2015

Study information

• Verified date: February 2016
• Source: Foisor Orthopedics Clinical Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Foisor Orthopedics Clinical Hospital

References & Publications (6)

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. Review. — View Citation

Ersan Ö, 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. — View Citation

Nørholt SE, Sindet-Pedersen S, Larsen U, Bang U, Ingerslev J, Nielsen O, Hansen HJ, Ersbøll AK. Pain control after dental surgery: a double-blind, randomised trial of lornoxicam versus morphine. Pain. 1996 Oct;67(2-3):335-43. — View Citation

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. Epub 2007 Oct 22. — View Citation

Sivrikoz N, Koltka K, Güresti E, Büget M, Sentürk M, Özyalçin 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.2014.098 — View Citation

Staunstrup H, Ovesen J, Larsen UT, Elbaek K, Larsen U, Krøner K. Efficacy and tolerability of lornoxicam versus tramadol in postoperative pain. J Clin Pharmacol. 1999 Aug;39(8):834-41. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption	Amount of IV and subcutaneous (SC) morphine (mg) required to reach NRS under 3	At 48 hours postoperative
Secondary	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
Secondary	Duration of analgesia	Time from spinal anesthesia until the first rescue morphine analgesia	At 48 hours postoperative