A Phase 4 interventional study of Intravenous study drug and Intravenous saline solution in Pain, Postoperative, Pain, Acute and Analgesia, sponsored by University of Chile. Completed at 1 site in Chile. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by University of Chile · Phase 4, Interventional, and Treatment
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 40 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University of Chile is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
ASA I - III BMI 20 - 35 (kg/m2)
Exclusion Criteria:
This arm will receive intravenous parecoxib in the intraoperative period.
Drug: Intravenous study drug
This arm will receive a placebo intravenous injection containing saline solution in the same volume as the intervention group
Other: Intravenous saline solution
40mg parecoxib will be administered intravenously after general anesthesia induction and before tourniquet inflation and surgical incisión
Saline solution (same volume as the study drug) will be administered intravenously after general anesthesia induction and before tourniquet inflation and surgical incision
Morphine consumption
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.
Time frame: 24 hours
Basal quadriceps strength in the operative side
Leg extension strength measured with a handheld dynamometer
Time frame: 1 hour before surgery
Basal level of pain during leg extension in the operative side
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)
Time frame: 1 hour before surgery
Basal plasmatic creatinine
Plasmatic creatinine level measured in mg/dL from a blood sample
Time frame: 1 hour before surgery
Nerve block performance time
Time elapsed between skin disinfection and the end of local anesthetic injection in femoral triangle and posterior capsule blocks.
Time frame: 5 minutes after anesthesia induction (before surgical incision)
Incidence of Block complications
Report of vascular puncture, hematoma, local anesthetic systemic toxicity symptoms
Time frame: 5 minutes after anesthesia induction and before surgical incision
Time to first morphine dose request
Time in minutes between arrival to post anesthesia care unit arrival and first request of morphine with the patient controlled analgesia device
Time frame: 24 hours
Morphine consumption during first 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.
Time frame: 48 hours
Incidence of opioid related side effects
Report of nausea, vomitus, pruritus, urinary retention, respiratory depression
Time frame: 48 hours
Incidence of NSAIDs related clinical side effects
Report of allergic reactions, pyrosis, evident gastrointestinal bleeding, hematoma
Time frame: 48 hours
Postoperative static pain level at 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)
Time frame: 3 hours
Postoperative dynamic pain level at 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)
Time frame: 3 hours
Postoperative static pain level at 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)
Time frame: 6 hours
Postoperative dynamic pain level at 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)
Time frame: 6 hours
Postoperative static pain level at 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)
Time frame: 12 hours
Postoperative dynamic pain level at 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)
Time frame: 12 hours
Postoperative static pain level at 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)
Time frame: 24 hours
Postoperative dynamic pain level at 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)
Time frame: 24 hours
Postoperative static pain level at 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)
Time frame: 48 hours
Postoperative dynamic pain level at 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)
Time frame: 48 hours
Medial malleolus sensory block level
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
Time frame: 3 hours
Lateral malleolus sensory block level
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
Time frame: 3hours
Medial malleolus sensory block level
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
Time frame: 24 hours
Lateral malleolus sensory block level
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
Time frame: 24 hours
Postoperative quadriceps strength
Leg extension strength measured with a handheld dynamometer
Time frame: 3 hours
Postoperative quadriceps strength
Leg extension strength measured with a handheld dynamometer
Time frame: 24 hours
Incidence of restriction to perform physiotherapy
Inability to perform physiotherapy secondary to pain or motor blockade
Time frame: 6 hours
Incidence of restriction to perform physiotherapy
Inability to perform physiotherapy secondary to pain or motor blockade
Time frame: 24 hours
Incidence of restriction to perform physiotherapy
Inability to perform physiotherapy secondary to pain or motor blockade
Time frame: 48 hours
Postoperative plasmatic creatinine level
Plasmatic creatinine level measured in mg/dL from a blood sample
Time frame: 48 hours
Plan to share: No — deidentified data under reasonable request
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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University of Chile