Clinical trial NCT04314505: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Knee Replacement
Postoperative Pain
Opioid Use
Keywords: Bilateral Total Knee Arthroplasty
Opioid Use
Opioid Sparing
Postoperative pain
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2020-03-19
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pain scores using numerical rating scale (VAS, 0 to 10) at rest
timeFrame: Post-operative 6 hours after surgery
measure: Pain scores using numerical rating scale (VAS, 0 to 10) at rest
timeFrame: Post-operative 12 hours after surgery
measure: Pain scores using numerical rating scale (VAS, 0 to 10) at rest
timeFrame: Post-operative 24 hours after surgery
measure: Pain scores using numerical rating scale (VAS, 0 to 10) at rest
timeFrame: Post-operative 48 hours after surgery
measure: Pain scores using numerical rating scale (VAS, 0 to 10) at rest
timeFrame: Post-operative 72 hours after surgery
measure: Pain scores using numerical rating scale (VAS, 0 to 10) at motion
timeFrame: Post-operative 24 hours after surgery
measure: Pain scores using numerical rating scale (VAS, 0 to 10) at motion
timeFrame: Post-operative 48 hour hours after surgery
measure: Pain scores using numerical rating scale (VAS, 0 to 10) at motion
timeFrame: Post-operative 72 hour hours after surgery
Secondary outcomes:
measure: maximum angle of continuous passive motion (CPM) as tolerated (Degrees)
timeFrame: 0-72 hours after surgery
measure: Cumulative morphine consumption(mg)
timeFrame: 0-72 hours after surgery
measure: drug-related (opioid) adverse events
timeFrame: 0-72 hours after surgery
measure: Satisfaction scale (0-100 points)
timeFrame: postoperative 2 weeks after surgery
measure: Length of hospital stay (LOS) (Days)
timeFrame: After surgery until discharge (about 3-5 days after surgery)
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: Dep. of Orthopedics and Traumatology, Taipei Veterans General Hospital
state: Taipei
Study officials:
affiliation: Department of Orthopaedic and Traumatology, Taipei Veterans General Hospital
name: Shang-Wen Tsai, M.D.
role: STUDY_DIRECTOR
References: