NCT04314505

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2020

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

March 20, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2020

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

March 12, 2020

Last Update Submit

July 19, 2020

Conditions

Knee ReplacementPostoperative PainOpioid Use

Keywords

Bilateral Total Knee ArthroplastyOpioid UseOpioid SparingPostoperative pain

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (5)

  • maximum angle of continuous passive motion (CPM) as tolerated (Degrees)

    0-72 hours after surgery

  • Cumulative morphine consumption(mg)

    0-72 hours after surgery

  • drug-related (opioid) adverse events

    0-72 hours after surgery

  • Satisfaction scale (0-100 points)

    postoperative 2 weeks after surgery

  • Length of hospital stay (LOS) (Days)

    After surgery until discharge (about 3-5 days after surgery)

Study Arms (2)

Opioid Sparing Protocol

EXPERIMENTAL

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

Opioid Based Patient Controlled Analgesia

ACTIVE COMPARATOR

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

Interventions

Opioid-Sparing ProtocolDRUG

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.

Also known as: OSP Protocol
Opioid Sparing Protocol
Opioid-Based Patient Controlled AnalgesiaDRUG

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.

Also known as: PCA Protocol
Opioid Based Patient Controlled Analgesia

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital

Taipei City, Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Shang-Wen Tsai, M.D.

    Department of Orthopaedic and Traumatology, Taipei Veterans General Hospital

    STUDY DIRECTOR

Central Study Contacts

Hsuan-Hsiao Ma, M.D.

CONTACT

02-28717557tyc20192@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2020

First Posted

March 19, 2020

Study Start

March 20, 2020

Primary Completion

June 20, 2020

Study Completion

August 20, 2020

Last Updated

July 21, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)