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Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia

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ClinicalTrials.gov Identifier: NCT03015532
Recruitment Status : Completed
First Posted : January 10, 2017
Results First Posted : October 27, 2021
Last Update Posted : October 27, 2021
Sponsor:
Information provided by (Responsible Party):
Heron Therapeutics

Study Description
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Brief Summary:
This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled, multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 administered via infiltration to the surgical site.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: HTX-011 Drug: Saline Placebo Drug: Bupivicaine HCl Drug: Ropivacaine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double-Blind, Saline Placebo- and Active-Controlled, Multicenter Study of HTX-011 Via Infiltration for Postoperative Analgesia in Subjects Undergoing Total Knee Arthroplasty
Actual Study Start Date : January 13, 2017
Actual Primary Completion Date : April 20, 2018
Actual Study Completion Date : May 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1, Group 1: HTX-011
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation
 Drug: HTX-011
HTX-011 (bupivacaine/meloxicam), via instillation
Experimental: Cohort 1, Group 2: HTX-011
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination)
 Drug: HTX-011
HTX-011 (bupivacaine/meloxicam), via instillation
Placebo Comparator: Cohort 1, Group 3: Saline Placebo
Saline placebo via injection
 Drug: Saline Placebo
Saline placebo via injection
Active Comparator: Cohort 1, Group 4: Bupivacaine HCI
Bupivacaine HCl without epinephrine, 125 mg via injection
 Drug: Bupivicaine HCl
Bupivacaine HCl without epinephrine
Experimental: Cohort 2, Group 1: HTX-011
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via instillation
 Drug: HTX-011
HTX-011 (bupivacaine/meloxicam), via instillation
Experimental: Cohort 2, Group 2: HTX-011 + Ropivacaine
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection
 Drug: HTX-011
HTX-011 (bupivacaine/meloxicam), via instillation

Drug: Ropivacaine
Ropivacaine, via injection
Placebo Comparator: Cohort 2, Group 3: Saline Placebo
Saline placebo via injection
 Drug: Saline Placebo
Saline placebo via injection
Active Comparator: Cohort 2, Group 4: Bupivacaine HCI
Bupivacaine HCl without epinephrine, 125 mg via injection
 Drug: Bupivicaine HCl
Bupivacaine HCl without epinephrine


Outcome Measures
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Primary Outcome Measures :
  1. Mean Area Under the Curve (AUC) of the NRS-R (Windowed Worst Observation Carried Forward) Pain Intensity Scores [ Time Frame: 48 hours ]
    Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded at rest (NRS-R).


Secondary Outcome Measures :
  1. Mean Area Under the Curve (AUC) of the NRS-R (Windowed Worst Observation Carried Forward) Pain Intensity Scores [ Time Frame: 72 hours ]
    Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded at rest (NRS-R).

  2. Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) [ Time Frame: 72 hours ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is scheduled to undergo primary unilateral TKA under general anesthesia.
  • 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 planned concurrent surgical procedure (eg, bilateral TKA).
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015532


Locations
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United States, Alabama
Mobile, Alabama, United States, 36608
Sheffield, Alabama, United States, 35660
United States, Arizona
Phoenix, Arizona, United States, 85015
Phoenix, Arizona, United States, 85023
United States, California
La Jolla, California, United States, 92037
Riverside, California, United States, 92503
San Diego, California, United States, 92103
United States, Florida
Miami, Florida, United States, 33136
Miami, Florida, United States, 33143
Miami, Florida, United States, 33155
Tamarac, Florida, United States, 33321
United States, Nevada
Las Vegas, Nevada, United States, 89109
United States, Ohio
Columbus, Ohio, United States, 43203
Columbus, Ohio, United States, 43210
Dayton, Ohio, United States, 45417
United States, Texas
Bellaire, Texas, United States, 77401
Houston, Texas, United States, 77004
Houston, Texas, United States, 77027
Houston, Texas, United States, 77043
Plano, Texas, United States, 75093
San Antonio, Texas, United States, 78209
San Antonio, Texas, United States, 78229
San Antonio, Texas, United States, 78240
Webster, Texas, United States, 77598
Sponsors and Collaborators
Heron Therapeutics
  Study Documents (Full-Text)

Documents provided by Heron Therapeutics:
Study Protocol  [PDF] December 21, 2017
Statistical Analysis Plan  [PDF] January 5, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Heron Therapeutics
ClinicalTrials.gov Identifier: NCT03015532    
Other Study ID Numbers: HTX-011-209
First Posted: January 10, 2017    Key Record Dates
Results First Posted: October 27, 2021
Last Update Posted: October 27, 2021
Last Verified: September 2021
Keywords provided by Heron Therapeutics:
knee
knee replacement
arthroplasty
joint replacement
knee pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Ropivacaine
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents