Parecoxib in Total Knee Arthroplasty
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Parecoxib This arm will receive intravenous parecoxib in the intraoperative period. |
Drug: Intravenous study drug
40mg parecoxib will be administered intravenously after general anesthesia induction and before tourniquet inflation and surgical incisión
|
| Placebo Comparator: Placebo This arm will receive a placebo intravenous injection containing saline solution in the same volume as the intervention group |
Other: Intravenous 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Basal quadriceps strength in the operative side [1 hour before surgery]
Leg extension strength measured with a handheld dynamometer
- 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)
- 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)
- 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
- Medial malleolus sensory block level [24 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 [24 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
- Postoperative quadriceps strength [3 hours]
Leg extension strength measured with a handheld dynamometer
- Postoperative quadriceps strength [24 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
- Incidence of restriction to perform physiotherapy [24 hours]
Inability to perform physiotherapy secondary to pain or motor blockade
- Incidence of restriction to perform physiotherapy [48 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Chile
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OAIC1308/22