Opioid-Sparing Protocol Comparing With Opioid-based Protocol After Bilateral Total Knee Arthroplasty

Study Overview
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Brief Summary
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The concern for the opioid use in the total knee arthroplasty continues to rise in recent decades. Historically, the total knee arthroplasty consumed high doses opioids in the postoperative periods. Compared to the Opioid-Based patient controlled analgesia(PCA), the opioid-sparing protocol may have benefits to decrease the concerns of the opioid use and opioid-related complication and provides the equivalent efficacy for pain control. The purpose of this trial in to provide a novel opioid-sparing protocol (OSP) to evaluate the efficacy for pain control and reducing the immediate postoperative opioid consumption.

Official Title
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Opioid-Sparing Protocol Using for Postoperative Pain Management Comparing With Opioid-based Patient Control Analgesia After Simultaneous Bilateral Total Knee Arthroplasty: a Randomized Controlled Trial

Conditions
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Knee Replacement, Postoperative Pain, Opioid Use

Intervention / Treatment
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* Drug: Opioid-Sparing Protocol
* Drug: Opioid-Based Patient Controlled Analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient with bilateral advanced knee osteoarthritis undergoing simultaneous bilateral total knee arthroplasty surgery willing to participate in this study and randomly allocated to either opioid-sparing protocol or PCA protocol. Exclusion Criteria: patient who refused to participate or with contraindication or hypersensitivity to any of the study drugs chronic pain disorder (exceeding 50 mg oral morphine equivalence per day at time of recruitment) substance abuse (e.g. alcoholism) severe renal impairment.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opioid Sparing Protocol<br>Preemptive(before incision): Parecoxib sodium 40 mg Postoperative: Parecoxib sodium 40 mg was given intravenously every 12 hours for 4 more doses. | Drug: Opioid-Sparing Protocol<br>* After a general anesthesia procedure was performed, an experienced anesthesiologist performed ultrasound guided adductor canal block procedures on both knees. In the opioid-sparing group, a dose of Parecoxib sodium 40 mg was administrated through intravenous route before the incision. After the surgery, Parecoxib sodium 40 mg was given intravenously every 12 hours for 4 more doses. Before the wound closure, the periarticular injection (each side 10 ml of 0.25% Bupivacaine) was done. The total dosage would be recorded in the device. All patients received oral paracetamol 500mg, 4 times a day and oral celecoxib 200mg, 2 times a day after surgery.<br>* Other names: OSP Protocol;|
| Active Comparator: Opioid Based Patient Controlled Analgesia<br>Preemptive(before incision) and Postoperative: the initial setting was 0.01mg/kg*hour, patient-controlled dose 2 mg, lock-out 5 minutes and limited 40mg in each 4 hours; adjusted by the PCA staff | Drug: Opioid-Based Patient Controlled Analgesia<br>* After a general anesthesia procedure was performed, an experienced anesthesiologist performed ultrasound guided adductor canal block procedures on both knees. The patient was informed that the intravenous bolus of rescue morphine (4mg) was available every 4 hours if the pain was intolerable. In the PCA group, the device was applied before incision and the initial setting was 0.01mg/kg*hour, patient-controlled dose 2 mg, lock-out 5 minutes and limited 40mg in each 4 hours. After the surgery, the staff of PCA group would visit the patients and adjusted the dosage. The PCA was removed after 72 hours from the surgery. Before the wound closure, the periarticular injection (each side 10 ml of 0.25% Bupivacaine) was done. The total dosage would be recorded in the device. All patients received oral paracetamol 500mg, 4 times a day and oral celecoxib 200mg, 2 times a day after surgery.<br>* Other names: PCA Protocol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores using numerical rating scale (VAS, 0 to 10) at rest | Post-operative 6 hours | Post-operative 6 hours after surgery | 
| Pain scores using numerical rating scale (VAS, 0 to 10) at rest | Post-operative 12 hours | Post-operative 12 hours after surgery | 
| Pain scores using numerical rating scale (VAS, 0 to 10) at rest | Post-operative 24 hours | Post-operative 24 hours after surgery | 
| Pain scores using numerical rating scale (VAS, 0 to 10) at rest | Post-operative 48 hours | Post-operative 48 hours after surgery | 
| Pain scores using numerical rating scale (VAS, 0 to 10) at rest | Post-operative 72 hours | Post-operative 72 hours after surgery | 
| Pain scores using numerical rating scale (VAS, 0 to 10) at motion | Post-operative 24 hours | Post-operative 24 hours after surgery | 
| Pain scores using numerical rating scale (VAS, 0 to 10) at motion | Post-operative 48 hours | Post-operative 48 hour hours after surgery | 
| Pain scores using numerical rating scale (VAS, 0 to 10) at motion | Post-operative 72 hours | Post-operative 72 hour hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum angle of continuous passive motion (CPM) as tolerated (Degrees) | recorded at post-operative 24 hours, 48 hours and 72 hours | 0-72 hours after surgery | 
| Cumulative morphine consumption(mg) | recorded at post-operative 24 hours, 48 hours and 72 hours | 0-72 hours after surgery | 
| drug-related (opioid) adverse events | nausea/vomiting, dizziness, urinary retention, pruritus, dry mouth, constipation, dyspepsia, GI bleeding, pitting edema over lower extremities, cardiovascular event, respiratory depression, delirium or coma | 0-72 hours after surgery | 
| Satisfaction scale (0-100 points) | satisfaction with regard to the efficacy and safety of the pain management protocol. | postoperative 2 weeks after surgery | 
| Length of hospital stay (LOS) (Days) | Time from admission to discharge | After surgery until discharge (about 3-5 days after surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bilateral Total Knee Arthroplasty, Opioid Use, Opioid Sparing, Postoperative pain