Analgesia, Analgesic Adverse Reaction, Analgesic Nephropathy, Knee Osteoarthritis, Pain, Acute, Pain, Postoperative
Conditions
Brief summary
Early mobilization and rehabilitation can be difficult after total knee arthroplasty (TKA) due to a high incidence of moderate to severe postoperative pain. Non-steroidal anti-inflammatory drugs (NSAIDs) are important to multimodal analgesic protocols. Parecoxib is an NSAID that selectively inhibits the enzyme cyclooxygenase-2 (COX-2). Clinical trials have shown that it does not alter platelet function or gastric mucosa. A recent study, after comparing ketorolac and parecoxib used at the same time in infiltration and systemically, found no differences in perioperative analgesia with a tendency to less bleeding in the parecoxib group. This randomized study will compare the effectiveness of adding a COX-2 inhibitor in the pain management of patients undergoing TKA as part of a multimodal analgesia regimen. The morphine consumption was selected as the primary outcome. The study hypothesis is that patients receiving parecoxib would have a lower opioid consumption.
Interventions
DRUGIntravenous study drug
40mg parecoxib will be administered intravenously after general anesthesia induction and before tourniquet inflation and surgical incisión
OTHERIntravenous saline solution
Saline solution (same volume as the study drug) will be administered intravenously after general anesthesia induction and before tourniquet inflation and surgical incision
Sponsors
University of Chile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
ASA I - III BMI 20 - 35 (kg/m2)
Exclusion criteria
* Adults who are not capable of giving their own consent * Pre-existing neuropathy (assessed in the history and physical examination) * Coagulation disturbance (assessed on history and physical examination, if clinically necessary, by blood test, i.e. platelets ≤ 100,000, international normalized ratio ≥ 1.4 or prothrombin time ≥ 50) * Renal failure (assessed by history and physical examination, if considered clinically necessary, by blood test, i.e. creatinine ≥ 1.04 mg/dl) * Hepatic impairment (assessed by history and physical examination, if considered clinically necessary, by blood tests, i.e. transaminases (GGT ≥ 50 u/lt) * Allergy to local anesthetics, morphine, paracetamol, ketorolac or parecoxib * Pregnancy * Chronic pain syndromes that require the use of opioids at home * Known history of sulfa allergy * History of ischemic heart disease * History of chronic gastritis or peptic ulcer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine consumption | 24 hours | Morphine consumed postoperatively during the first 24 hrs utilizing a patient-controlled analgesia device programmed 1mg/ml morphine solution, no infusion, 1ml dose, 8 minutes lockout. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Basal level of pain during leg extension in the operative side | 1 hour before surgery | Pain level measured with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain) |
| Basal plasmatic creatinine | 1 hour before surgery | Plasmatic creatinine level measured in mg/dL from a blood sample |
| Nerve block performance time | 5 minutes after anesthesia induction (before surgical incision) | Time elapsed between skin disinfection and the end of local anesthetic injection in femoral triangle and posterior capsule blocks. |
| Incidence of Block complications | 5 minutes after anesthesia induction and before surgical incision | Report of vascular puncture, hematoma, local anesthetic systemic toxicity symptoms |
| Time to first morphine dose request | 24 hours | Time in minutes between arrival to post anesthesia care unit arrival and first request of morphine with the patient controlled analgesia device |
| Morphine consumption during first 48 hours | 48 hours | Morphine consumed postoperatively during the first 48 hrs utilizing a patient-controlled analgesia device programmed 0.01mg/Kg/ml morphine solution, no infusion, 1ml dose, 8 minutes lockout. |
| Incidence of opioid related side effects | 48 hours | Report of nausea, vomitus, pruritus, urinary retention, respiratory depression |
| Incidence of NSAIDs related clinical side effects | 48 hours | Report of allergic reactions, pyrosis, evident gastrointestinal bleeding, hematoma |
| Postoperative static pain level at 3 hours | 3 hours | Pain level measured at rest with an 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain) |
| Postoperative dynamic pain level at 3 hours | 3 hours | Pain level measured during leg extension with an 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain) |
| Postoperative static pain level at 6 hours | 6 hours | Pain level measured at rest with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain) |
| Basal quadriceps strength in the operative side | 1 hour before surgery | Leg extension strength measured with a handheld dynamometer |
| Postoperative static pain level at 12 hours | 12 hours | Pain level measured at rest with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain) |
| Postoperative dynamic pain level at 12 hours | 12 hours | Pain level measured during leg extension with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain) |
| Postoperative static pain level at 24 hours | 24 hours | Pain level measured at rest with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain) |
| Postoperative dynamic pain level at 24 hours | 24 hours | Pain level measured during leg extension with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain) |
| Postoperative static pain level at 48 hours | 48 hours | Pain level measured at rest with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain) |
| Postoperative dynamic pain level at 48 hours | 48 hours | Pain level measured during leg extension with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain) |
| Medial malleolus sensory block level | 3 hours | 0 to 2 points for Sensory block to cold and touch in the medial malleolus. 0 point= can feel cold and touch; 1= can feel touch but not cold; 2= cannot feel cold or touch |
| Lateral malleolus sensory block level | 3hours | 0 to 2 points for Sensory block to cold and touch in the medial malleolus. 0 point= can feel cold and touch; 1= can feel touch but not cold; 2= cannot feel cold or touch |
| Postoperative quadriceps strength | 3 hours | Leg extension strength measured with a handheld dynamometer |
| Incidence of restriction to perform physiotherapy | 6 hours | Inability to perform physiotherapy secondary to pain or motor blockade |
| Postoperative plasmatic creatinine level | 48 hours | Plasmatic creatinine level measured in mg/dL from a blood sample |
| Postoperative dynamic pain level at 6 hours | 6 hours | Pain level measured during leg extension with a 11-points numeric rating scale (from 0 to 10 where 0 means absence of pain and 10 the worst imaginable pain) |
Countries
Chile
Outcome results
None listed