A Pilot Randomized Controlled Trial of Suzetrigine as an Adjunct to Multimodal Analgesia Following Total Knee Arthroplasty
This proposal seeks to determine if the addition of Suzetrigine, a novel non-opioid pain medication, to a standardized multimodal pain management pathway significantly reduces total postoperative opioid consumption (measured in Morphine Milligram Equivalents [MME]) and improves patient-reported pain scores during the first 14 days following primary total knee arthroplasty (TKA). Prior to conducting a definitive randomized control trial (RCT), we propose a pilot study to inform the trial's design and feasibility.
Objective: To inform the design and feasibility of a definitive RCT comparing postoperative pain control with and without Suzetrigine after TKA. To achieve this objective, we will conduct a pilot trial and address the following aims:
1) to determine if participant enrollment is feasible, 2) to assess compliance with treatment protocol and key aspects of the protocol, and 3) to refine data collection methods.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 4
Kontakter och platser
Studiekontakt
- Namn: Peter Hsiue, MD
- Telefonnummer: 714-456-7012
- E-post: phsiue@hs.uci.edu
Studera Kontakt Backup
- Namn: Steven Yang, MD
- Telefonnummer: 714-456-7012
- E-post: stevey1@hs.uci.edu
Studieorter
-
-
California
-
Orange, California, Förenta staterna, 92868
- UCI Health Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Adults aged 18 to 80 years
- Diagnosis of knee osteoarthritis
- Scheduled for unilateral TKA
- Willingness to maintain a 14-day medication and pain log
Exclusion Criteria:
- Chronic opioid use
- Severe renal impairment (eGFR < 30 mL/min) or severe hepatic impairment (Child-Pugh Class C)
- History of active peptic ulcer disease or GI bleeding
- Known allergies to any of the study medications (suzetrigine, acetaminophen, meloxicam, or oxycodone).
- Significant peripheral neuropathy in the operative extremity
- Active history of substance abuse or opioid use disorder
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Standard Multimodal Group
Standard multimodal control group will receive treatment components such as nerve block through an adductor canal catheter for 4 days, cryotherapy/icing as needed, scheduled non-opioid drug (acetaminophen 1000 mg 3 times a day), nonsteroidal anti-inflammatory drug (NSAID) (Meloxicam 15mg daily), and breakthrough opioid (Oxycodone 5mg every 4 hours as needed). |
|
|
Experimentell: Suzetrigine Group
The Suzetrigine group will receive a 100 mg loading dose of Suzetrigine, followed by 50mg Q12h for 14 days as an addition to a standardized multimodal pain management pathway. The standardized multimodal pain management pathway consists of treatment components such as nerve block through an adductor canal catheter for 4 days, cryotherapy/icing as needed, scheduled non-opioid drug (acetaminophen 1000 mg 3 times a day), nonsteroidal anti-inflammatory drug (NSAID) (Meloxicam 15mg daily), and breakthrough opioid (Oxycodone 5mg every 4 hours as needed). |
100 mg loading dose of Suzetrigine, followed by 50mg every 12 hours for 14 days as an addition to a standardized multimodal pain management pathway. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Participant enrollment
Tidsram: At enrollment
|
Enrollment rates |
At enrollment
|
|
Protocol adherence
Tidsram: Within 14 days
|
Protocol adherence rates |
Within 14 days
|
|
Data collection
Tidsram: At 14 days
|
Completeness of data collection |
At 14 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Primary Clinical Outcome: Opioid consumption
Tidsram: Within 14 days
|
Total cumulative opioid consumption in milligrams morphine equivalents (MME) within the study period |
Within 14 days
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain
Tidsram: At 14 days
|
Numeric Pain Rating Scale (NPRS): Zero is equivalent to no pain and 10 indicates the worst possible pain. |
At 14 days
|
|
First day of walking unassisted
Tidsram: Within 14 days
|
Within 14 days
|
|
|
Barthel Index for Activities of Daily Living (ADL)
Tidsram: At 14 days
|
Cumulative score ranges from 0 to 100, where 0 indicates complete dependence and 100 signifies total independence |
At 14 days
|
|
Knee injury and Osteoarthritis Outcome Score (KOOS)
Tidsram: At 14 days
|
0 represents extreme knee problems, and 100 represents no knee problems |
At 14 days
|
|
Knee range of motion
Tidsram: At 14 days
|
Clinical assessment |
At 14 days
|
|
Time to opioid cessation
Tidsram: Within 14 days
|
Within 14 days
|
|
|
Opioid prescription renewal
Tidsram: Within 14 days
|
Within 14 days
|
|
|
Incidence of opioid-related adverse events
Tidsram: Within 14 days
|
Within 14 days
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Peter Hsiue, MD, University of California, Irvine
- Huvudutredare: Steven Yang, MD, University of California, Irvine
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- STUDY00001001
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