Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia
NCT ID: NCT03015532
Last Updated: 2025-03-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
285 participants
INTERVENTIONAL
2017-01-13
2018-05-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort 1, Group 1: HTX-011
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation
HTX-011
HTX-011 (bupivacaine/meloxicam), via instillation
Cohort 1, Group 2: HTX-011
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination)
HTX-011
HTX-011 (bupivacaine/meloxicam), via instillation
Cohort 1, Group 3: Saline Placebo
Saline placebo via injection
Saline Placebo
Saline placebo via injection
Cohort 1, Group 4: Bupivacaine HCI
Bupivacaine HCl without epinephrine, 125 mg via injection
Bupivicaine HCl
Bupivacaine HCl without epinephrine
Cohort 2, Group 1: HTX-011
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via instillation
HTX-011
HTX-011 (bupivacaine/meloxicam), via instillation
Cohort 2, Group 2: HTX-011 + Ropivacaine
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection
HTX-011
HTX-011 (bupivacaine/meloxicam), via instillation
Ropivacaine
Ropivacaine, via injection
Cohort 2, Group 3: Saline Placebo
Saline placebo via injection
Saline Placebo
Saline placebo via injection
Cohort 2, Group 4: Bupivacaine HCI
Bupivacaine HCl without epinephrine, 125 mg via injection
Bupivicaine HCl
Bupivacaine HCl without epinephrine
Interventions
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HTX-011
HTX-011 (bupivacaine/meloxicam), via instillation
Saline Placebo
Saline placebo via injection
Bupivicaine HCl
Bupivacaine HCl without epinephrine
Ropivacaine
Ropivacaine, via injection
Eligibility Criteria
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Inclusion Criteria
* Has not previously undergone TKA in either knee.
* Has an American Society of Anesthesiologists Physical Status of I, II, or III.
* Is able to demonstrate motor function by performing a timed 20-meter walk unassisted, but with the optional use of a 4-legged walker for balance.
* Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.
Exclusion Criteria
* Has a pre-existing concurrent acute or chronic painful/restrictive physical condition that may require analgesic treatment in the postoperative period for pain.
* Has a contraindication or a known or suspected history of hypersensitivity or idiosyncratic reaction to required study medications.
* Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
* Has taken NSAIDs within 10 days prior to the scheduled surgery.
* Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting).
* Has been administered bupivacaine within 5 days prior to the scheduled surgery.
* Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control.
* Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug.
* Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments.
* Has a known history of Hepatitis B, human immunodeficiency virus (HIV), or active Hepatitis C.
* Has uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments.
* Has any chronic neuromuscular deficit of either femoral nerve function or thigh musculature. Has any chronic condition or disease that would compromise neurological or vascular assessments.
* Had a malignancy in the last year, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
* Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse.
* Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.
* Has undergone 3 or more surgeries within 12 months.
* Has a body mass index (BMI) \>38 kg/m2.
18 Years
ALL
No
Sponsors
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Heron Therapeutics
INDUSTRY
Responsible Party
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Locations
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Mobile, Alabama, United States
Sheffield, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
La Jolla, California, United States
Riverside, California, United States
San Diego, California, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Tamarac, Florida, United States
Las Vegas, Nevada, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Bellaire, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Webster, Texas, United States
Countries
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References
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Lachiewicz PF, Lee GC, Pollak RA, Leiman DG, Hu J, Sah AP. HTX-011 Reduced Pain and Opioid Use After Primary Total Knee Arthroplasty: Results of a Randomized Phase 2b Trial. J Arthroplasty. 2020 Oct;35(10):2843-2851. doi: 10.1016/j.arth.2020.05.044. Epub 2020 May 27.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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HTX-011-209
Identifier Type: -
Identifier Source: org_study_id
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