Lornoxicam Versus Etoricoxib in Postoperative Pain After Total Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT02750917|
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : April 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Lornoxicam Drug: Etoricoxib||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Comparative Study of Efficacy and Safety of Lornoxicam Versus Etoricoxib After Total Knee Arthroplasty|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||March 2015|
Experimental: GROUP LORNOXICAM
Immediately in postoperative care unit patients received lornoxicam 8 mg PO/12 hours for 48 hours
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.
Active Comparator: GROUP ETORICOXIB
Immediately in postoperative care unit patients received etoricoxib 120 mg PO and another pill at 24 hours.
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.
- Total morphine consumption [ Time Frame: At 48 hours postoperative ]Amount of IV and subcutaneous (SC) morphine (mg) required to reach NRS under 3
- Number of patients with side effects of drugs used [ Time Frame: 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 [ Time Frame: At 48 hours postoperative ]Time from spinal anesthesia until the first rescue morphine analgesia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750917
|Study Director:||Ioan Cristian Stoica, Prof||Foisor Orthopedics Clinical Hospital|