Postoperative Pain
Conditions
Keywords
postoperative pain, lornoxicam, etoricoxib, total knee arthroplasty
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.
Interventions
DRUGLornoxicam
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.
DRUGEtoricoxib
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.
Sponsors
Foisor Orthopedics Clinical Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine consumption | At 48 hours postoperative | Amount of IV and subcutaneous (SC) morphine (mg) required to reach NRS under 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with side effects of drugs used | 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 | At 48 hours postoperative | Time from spinal anesthesia until the first rescue morphine analgesia |
Outcome results
None listed