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Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA

ConditionsPeriarticular BlockOsteoarthritis (OA)Osteoarthritis (OA) of the KneePain After SurgeryKnee Arthroplasty, Total
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-89
SponsorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

About this trial

Prospective Cohort of patients who are scheduled for a Robot Assisted Total Knee Arthroplasty (RATKA). A prospective survey of patient reported outcome measures (Numeric Rating Scale) will be obtained postoperatively of 72 hours, as well as at the postoperative opioid consumption after 72 hours.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • bupivacaine-meloxicam (extended release)

    Combination product

    These surgeons will be using Zynrelef (bupivacaine-meloxicam extended release) as a form of periarticular analgesia.

  • Bupivacaine

    Drug

    These surgeons will be using the control injection (bupivacaine + ketorolac + lidocaine) as a form of periarticular analgesia.

  • Ketorolac

    Drug

    These surgeons will be using the control injection (bupivacaine + ketorolac + lidocaine) as a form of periarticular analgesia.

  • Lidocaine (drug)

    Drug

    These surgeons will be using the control injection (bupivacaine + ketorolac + lidocaine) as a form of periarticular analgesia.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: ZynrelefExperimental treatment 1 intervention
Group B: ControlActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Amount of opioid medications used (measured in morphine milligrams equivalents)

Self-report of opioid medications

Time frame
From completion of surgery to 3 days post-op
2

Patient reported outcome measure (Numeric Rating Scale)

Self-report of pain using numeric scale. Title: Numeric Rating Scale; Ranges from 0 to 10, where 10 is maximal pain and 0 is no pain at all.

Time frame
From completion of surgery to 3 days post-op

Secondary outcomes

1

Amount of oral Over-the-counter (OTC) pain reliever medications used

Self-report of Over-the-counter (OTC) pain relievers

Time frame
From completion of surgery to 3 days post-operation
2

Complications and Adverse Events

Report of adverse events

Time frame
From completion of surgery to 3 days post-op

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Lead sponsor

Source ClinicalTrials.gov

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