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

Primary Purpose

Knee Replacement, Postoperative Pain, Opioid Use

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Opioid-Sparing Protocol
Opioid-Based Patient Controlled Analgesia
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Replacement focused on measuring Bilateral Total Knee Arthroplasty, Opioid Use, Opioid Sparing, Postoperative pain

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dep. of Orthopedics and Traumatology, Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Opioid Sparing Protocol

Opioid Based Patient Controlled Analgesia

Arm Description

Preemptive(before incision): Parecoxib sodium 40 mg Postoperative: Parecoxib sodium 40 mg was given intravenously every 12 hours for 4 more doses.

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

Outcomes

Primary Outcome Measures

Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Post-operative 6 hours
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Post-operative 12 hours
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Post-operative 24 hours
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Post-operative 48 hours
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Post-operative 72 hours
Pain scores using numerical rating scale (VAS, 0 to 10) at motion
Post-operative 24 hours
Pain scores using numerical rating scale (VAS, 0 to 10) at motion
Post-operative 48 hours
Pain scores using numerical rating scale (VAS, 0 to 10) at motion
Post-operative 72 hours

Secondary Outcome Measures

maximum angle of continuous passive motion (CPM) as tolerated (Degrees)
recorded at post-operative 24 hours, 48 hours and 72 hours
Cumulative morphine consumption(mg)
recorded at post-operative 24 hours, 48 hours and 72 hours
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
Satisfaction scale (0-100 points)
satisfaction with regard to the efficacy and safety of the pain management protocol.
Length of hospital stay (LOS) (Days)
Time from admission to discharge

Full Information

First Posted
March 12, 2020
Last Updated
July 19, 2020
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT04314505
Brief Title
Opioid-Sparing Protocol Comparing With Opioid-based Protocol After Bilateral Total Knee Arthroplasty
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2020 (Actual)
Primary Completion Date
June 20, 2020 (Actual)
Study Completion Date
August 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Replacement, Postoperative Pain, Opioid Use
Keywords
Bilateral Total Knee Arthroplasty, Opioid Use, Opioid Sparing, Postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Opioid Sparing Protocol
Arm Type
Experimental
Arm Description
Preemptive(before incision): Parecoxib sodium 40 mg Postoperative: Parecoxib sodium 40 mg was given intravenously every 12 hours for 4 more doses.
Arm Title
Opioid Based Patient Controlled Analgesia
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Opioid-Sparing Protocol
Other Intervention Name(s)
OSP Protocol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Opioid-Based Patient Controlled Analgesia
Other Intervention Name(s)
PCA Protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Description
Post-operative 6 hours
Time Frame
Post-operative 6 hours after surgery
Title
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Description
Post-operative 12 hours
Time Frame
Post-operative 12 hours after surgery
Title
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Description
Post-operative 24 hours
Time Frame
Post-operative 24 hours after surgery
Title
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Description
Post-operative 48 hours
Time Frame
Post-operative 48 hours after surgery
Title
Pain scores using numerical rating scale (VAS, 0 to 10) at rest
Description
Post-operative 72 hours
Time Frame
Post-operative 72 hours after surgery
Title
Pain scores using numerical rating scale (VAS, 0 to 10) at motion
Description
Post-operative 24 hours
Time Frame
Post-operative 24 hours after surgery
Title
Pain scores using numerical rating scale (VAS, 0 to 10) at motion
Description
Post-operative 48 hours
Time Frame
Post-operative 48 hour hours after surgery
Title
Pain scores using numerical rating scale (VAS, 0 to 10) at motion
Description
Post-operative 72 hours
Time Frame
Post-operative 72 hour hours after surgery
Secondary Outcome Measure Information:
Title
maximum angle of continuous passive motion (CPM) as tolerated (Degrees)
Description
recorded at post-operative 24 hours, 48 hours and 72 hours
Time Frame
0-72 hours after surgery
Title
Cumulative morphine consumption(mg)
Description
recorded at post-operative 24 hours, 48 hours and 72 hours
Time Frame
0-72 hours after surgery
Title
drug-related (opioid) adverse events
Description
nausea/vomiting, dizziness, urinary retention, pruritus, dry mouth, constipation, dyspepsia, GI bleeding, pitting edema over lower extremities, cardiovascular event, respiratory depression, delirium or coma
Time Frame
0-72 hours after surgery
Title
Satisfaction scale (0-100 points)
Description
satisfaction with regard to the efficacy and safety of the pain management protocol.
Time Frame
postoperative 2 weeks after surgery
Title
Length of hospital stay (LOS) (Days)
Description
Time from admission to discharge
Time Frame
After surgery until discharge (about 3-5 days after surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsuan-Hsiao Ma, M.D.
Phone
02-28717557
Email
tyc20192@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shang-Wen Tsai, M.D.
Organizational Affiliation
Department of Orthopaedic and Traumatology, Taipei Veterans General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital
City
Taipei city
State/Province
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shang-Wen Tsai, Dr.
Phone
+886-2-28717557
Email
swtsai.vghtpe@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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