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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05188053
Other study ID # 21-010044
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date February 7, 2022
Est. completion date January 2025

Study information

Verified date November 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare an FDA-approved medication for post-operative pain control (HTX-011) to the standard of care institutional practice for periarticular analgesia after primary total knee arthroplasty (weight based dosing of Ropivacaine, epinephrine and ketorolac diluted with saline). We are doing this research study to find out if this new medication provides superior pain control within 72 hours following surgery.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 98
Est. completion date January 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - ASA classification I to III, older than or equal to 18 years old. - Presenting for primary total knee replacement for degenerative joint disease. - Patient capable of providing their own informed consent. Exclusion Criteria: - Vulnerable study populations including prisoners. - Patients with a contralateral total knee arthroplasty < 2 years prior to the index procedure. - Compromised health barring them from proceeding with surgery including acute or chronic kidney injury identified pre-operative. - Patients unable to provide their own informed consent. - Pregnancy. - Patients with documented chronic pain syndromes. - Patients with a history of prolonged daily opioids (more than 1 month) with an oral morphine equivalent of greater than 5mg/day. - BMI > 45 kg/m^2. - Allergies to any component of the study medications, including specific history of type 1 hypersensitivities to any NSAID. - Patients with impaired cognitive function. - Major systemic illnesses such as severe renal (estimated glomerular filtration rate less than 50ml/min), coronary artery disease requiring a bypass graft (CABG), other cardiac problems including congestive heart failure (CHF New York Heart Association class III to IV), or severe hepatic disorders defined as current or past diagnosis of acute/subacute liver necrosis, acute hepatic failure, chronic liver disease, liver abscess, hepatic coma, hepatorenal syndrome and other disorders of the liver.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HTX-011
Single dose administration periarticular 400mg bupivacaine and 12mg meloxicam extended release solution
ropivacaine , epinephrine , ketorolac diluted in sodium chloride
Single dose administration in 100cc of standard formulation, there is 225mg of ropivacaine 5mg/mL, 0.6mg epinephrine 1mg/mL, 30mg ketorolac 30mg/mL diluted in sodium chloride

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain control at 72 hours Mean patient reported (0-10) numeric rating scale (NRS) pain scores at 72 hours postoperative 72-hours postoperative total knee arthroplasty
Secondary Pain control at 48 hours Mean patient reported (0-10) numeric rating scale (NRS) pain scores at 48 hours postoperative 48-hours postoperative total knee arthroplasty
Secondary Pain control at 24 hours Mean patient reported (0-10) numeric rating scale (NRS) pain scores at 24 hours postoperative 24-hours postoperative total knee arthroplasty
Secondary Opioid consumption Total postoperative opioid consumption standardized into morphine milligram equivalents (MMEs) 72-hours postoperative total knee arthroplasty
Secondary Hospital length of stay Total number of days admitted to the hospital approximately 3 days
Secondary Distance walked at time of discharge with PT Distance walked by the participate with physical therapist (PT) at the time of discharge measured in meters approximately 3 days
See also
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