Parecoxib in Total Knee Arthroplasty

University of Chile40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pain, Postoperative Pain, Acute Analgesia

Interventions

Intravenous study drugDRUG

40mg parecoxib will be administered intravenously after general anesthesia induction and before tourniquet inflation and surgical incisión

Intravenous saline solutionOTHER

Saline solution (same volume as the study drug) will be administered intravenously after general anesthesia induction and before tourniquet inflation and surgical incision

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Parecoxib in Total Knee Arthroplasty

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes