Lornoxicam Versus Etoricoxib in Postoperative Pain After Total Knee Arthroplasty
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Lornoxicam
Etoricoxib
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring postoperative pain, lornoxicam, etoricoxib, total knee arthroplasty
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GROUP LORNOXICAM
GROUP ETORICOXIB
Arm Description
Immediately in postoperative care unit patients received lornoxicam 8 mg PO/12 hours for 48 hours
Immediately in postoperative care unit patients received etoricoxib 120 mg PO and another pill at 24 hours.
Outcomes
Primary Outcome Measures
Total morphine consumption
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
Number of patients with postoperative nausea and vomiting (PONV) or respiratory depression or gastric complaint or allergic reactions
Duration of analgesia
Time from spinal anesthesia until the first rescue morphine analgesia
Full Information
NCT ID
NCT02750917
First Posted
February 18, 2016
Last Updated
April 25, 2016
Sponsor
Foisor Orthopedics Clinical Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02750917
Brief Title
Lornoxicam Versus Etoricoxib in Postoperative Pain After Total Knee Arthroplasty
Official Title
A Comparative Study of Efficacy and Safety of Lornoxicam Versus Etoricoxib After Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Foisor Orthopedics Clinical Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
postoperative pain, lornoxicam, etoricoxib, total knee arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GROUP LORNOXICAM
Arm Type
Experimental
Arm Description
Immediately in postoperative care unit patients received lornoxicam 8 mg PO/12 hours for 48 hours
Arm Title
GROUP ETORICOXIB
Arm Type
Active Comparator
Arm Description
Immediately in postoperative care unit patients received etoricoxib 120 mg PO and another pill at 24 hours.
Intervention Type
Drug
Intervention Name(s)
Lornoxicam
Other Intervention Name(s)
XEFO RAPID, XEFO
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Etoricoxib
Other Intervention Name(s)
Arcoxia, Tauxib
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total morphine consumption
Description
Amount of IV and subcutaneous (SC) morphine (mg) required to reach NRS under 3
Time Frame
At 48 hours postoperative
Secondary Outcome Measure Information:
Title
Number of patients with side effects of drugs used
Description
Number of patients with postoperative nausea and vomiting (PONV) or respiratory depression or gastric complaint or allergic reactions
Time Frame
At 48 hours postoperative
Title
Duration of analgesia
Description
Time from spinal anesthesia until the first rescue morphine analgesia
Time Frame
At 48 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ioan Cristian Stoica, Prof
Organizational Affiliation
Foisor Orthopedics Clinical Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23428763
Citation
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.
Results Reference
background
PubMed Identifier
10434236
Citation
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.
Results Reference
background
PubMed Identifier
17953792
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. doi: 10.1017/S0265021507002827. Epub 2007 Oct 22.
Results Reference
background
PubMed Identifier
24481580
Citation
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.
Results Reference
result
PubMed Identifier
8951927
Citation
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.
Results Reference
result
PubMed Identifier
19606021
Citation
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.
Results Reference
result
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Lornoxicam Versus Etoricoxib in Postoperative Pain After Total Knee Arthroplasty
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