Health TrialsbyHealthPanel

Suzetrigine Versus Usual-care Opioids for Postop Pain in Sports

ConditionPostoperative Pain Management
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Los Angeles

About this trial

The goal of this clinical trial is to learn if a Suzetrigine-based multimodal pain regimen can reduce the volume of opioid consumption while maintaining non-inferior pain control compared to an opioid-based multimodal pain regimen after common ambulatory orthopaedic sports procedures. The main questions it aims to answer are:

1. Does including Suzetrigine in the multimodal pain regimen lower the volume of opioids consumed by participants while maintaining non-inferior pain control? 2. How does the side-effect profile of a Suzetrigine-based multimodal postop pain regimen compare to that of an opioid-based multimodal postoperative pain regimen?

Eligible participants will be assigned to receive one of the postop pain regimens and report their opioid use, their pain level, and the side effects they faced every day for 7 days.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing reconstruction of primary ACL tear

Disqualifiers

Concurrent ligamentous injuries requiring surgical intervention

Full thickness cartilage injury requiring discrete surgical intervention

Chronic opioid use

Significant hepatic disease (Child/Pugh C)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Suzetrigine

    Drug

    Patients in this group will receive a preoperative regional anesthesia block, a 14-day supply of 1000mg acetaminophen BID, a 14-day supply of 500mg naproxen BID, a loading dose of Suzetrigine 100mg in PACU postoperatively, a 7-day supply of 50mg suzetrigine BID and 25 tablets of 5mg of oxycodone for rescue pain control postoperatively.

  • Multimodal Pain Regimen

    Drug

    Patients in this group will receive a preoperative regional anesthesia block, a 14-day supply of 1000mg acetaminophen BID, a 14-day supply of 500mg naproxen BID, and 25 tablets of 5mg of oxycodone for PRN pain control postoperatively.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Suzetrigine ArmExperimental treatment 1 intervention
Group B: Opioid ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

7-Day MME Consumption

Total opioids consumed by patients measured in morphine milliequivalents for the first seven days postoperatively

Time frame
7 days

Secondary outcomes

1

SPID-48

Time-weighted Sum of Pain Intensity Difference over 48 hours used to quantify pain relief by summing a patient's pain reduction from their baseline score over a 48-hour period.

Time frame
48 hours
2

7-Day Opioid Free Rate

The percentage of patients who avoid opioid use after medical procedures

Time frame
7 days
3

Opioid Side Effect Rate

Proportion of patients reporting instances of nausea, constipation, dizziness, or loss of appetite

Time frame
7 days
4

Suzetrigine Side Effect Rate

Proportion of patients reporting muscle aches, muscle spasm, or itchiness

Time frame
7 Days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: