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

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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain; Knee Replacement; Opioid Use
• Intervention / Treatment: Drug: Opioid-Sparing Protocol; Drug: Opioid-Based Patient Controlled Analgesia

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei
    • Taipei city, Taipei, Taiwan, 112
      • Recruiting
      • Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital
      • Contact: Shang-Wen Tsai, Dr.; Phone Number: +886-2-28717557; Email: swtsai.vghtpe@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Opioid-Sparing Protocol; 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.; Other Names: OSP Protocol
Active Comparator: 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	Drug: Opioid-Based Patient Controlled Analgesia; 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.; Other Names: PCA Protocol

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Study Director: Shang-Wen Tsai, M.D., Department of Orthopaedic and Traumatology, Taipei Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2020
• Primary Completion (Actual): June 20, 2020
• Study Completion (Anticipated): August 20, 2020

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 19, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Opioid Use; Postoperative pain; Bilateral Total Knee Arthroplasty; Opioid Sparing
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 2020-02-008C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No