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

Phase 4

• Conditions: Postoperative Pain; Knee Replacement; Opioid Use
• Interventions: Drug: Opioid-Sparing Protocol; Drug: Opioid-Based Patient Controlled Analgesia

• Registration Number: NCT04314505
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-19
• Study Start: 2020-03-20
• Primary Completion: 2020-06-20
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-19
• Last Update Posted: 2020-07-21
• Study Completion: 2020-08-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid Sparing Protocol	Opioid-Sparing Protocol	Preemptive(before incision): Parecoxib sodium 40 mg Postoperative: Parecoxib sodium 40 mg was given intravenously every 12 hours for 4 more doses.
Opioid Based Patient Controlled Analgesia	Opioid-Based Patient Controlled Analgesia	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

Primary Outcome Measures

Name	Time	Method
Pain scores using numerical rating scale (VAS, 0 to 10) at motion	Post-operative 72 hour hours after surgery	Post-operative 72 hours
Pain scores using numerical rating scale (VAS, 0 to 10) at rest	Post-operative 72 hours after surgery	Post-operative 72 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital; 🇨🇳 Taipei city, Taipei, Taiwan