Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia
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
1 other identifier
interventional
285
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 postoperative-pain
Started Jan 2017
Typical duration for phase_2 postoperative-pain
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2017
CompletedFirst Posted
Study publicly available on registry
January 10, 2017
CompletedStudy Start
First participant enrolled
January 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2018
CompletedResults Posted
Study results publicly available
October 27, 2021
CompletedMarch 2, 2026
February 1, 2026
1.3 years
January 6, 2017
June 11, 2021
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores at Rest (NRS-R) Through 48 Hours Postsurgery (AUC0-48).
Pain intensity is assessed at rest using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-48 is 0-480.
48 hours
Secondary Outcomes (2)
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores at Rest (NRS-R) Through 72 Hours Postsurgery (AUC0-72).
72 hours
Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)
72 hours
Study Arms (8)
Cohort 1, Group 1: HTX-011
EXPERIMENTALHTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation
Cohort 1, Group 2: HTX-011
EXPERIMENTALHTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination)
Cohort 1, Group 3: Saline Placebo
PLACEBO COMPARATORSaline placebo via injection
Cohort 1, Group 4: Bupivacaine HCI
ACTIVE COMPARATORBupivacaine HCl without epinephrine, 125 mg via injection
Cohort 2, Group 1: HTX-011
EXPERIMENTALHTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via instillation
Cohort 2, Group 2: HTX-011 + Ropivacaine
EXPERIMENTALHTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection
Cohort 2, Group 3: Saline Placebo
PLACEBO COMPARATORSaline placebo via injection
Cohort 2, Group 4: Bupivacaine HCI
ACTIVE COMPARATORBupivacaine HCl without epinephrine, 125 mg via injection
Interventions
HTX-011 (bupivacaine/meloxicam), via instillation
Saline placebo via injection
Bupivacaine HCl without epinephrine
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Sheffield, Alabama, 35660, United States
Unknown Facility
Phoenix, Arizona, 85015, United States
Unknown Facility
Phoenix, Arizona, 85023, United States
Unknown Facility
La Jolla, California, 92037, United States
Unknown Facility
Riverside, California, 92503, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Miami, Florida, 33143, United States
Unknown Facility
Miami, Florida, 33155, United States
Unknown Facility
Tamarac, Florida, 33321, United States
Unknown Facility
Las Vegas, Nevada, 89109, United States
Unknown Facility
Columbus, Ohio, 43203, United States
Unknown Facility
Columbus, Ohio, 43210, United States
Unknown Facility
Dayton, Ohio, 45417, United States
Unknown Facility
Bellaire, Texas, 77401, United States
Unknown Facility
Houston, Texas, 77004, United States
Unknown Facility
Houston, Texas, 77027, United States
Unknown Facility
Houston, Texas, 77043, United States
Unknown Facility
Plano, Texas, 75093, United States
Unknown Facility
San Antonio, Texas, 78209, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
San Antonio, Texas, 78240, United States
Unknown Facility
Webster, Texas, 77598, United States
Related Publications (1)
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.
PMID: 32561266DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tricia Mulford
- Organization
- Heron Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2017
First Posted
January 10, 2017
Study Start
January 13, 2017
Primary Completion
April 20, 2018
Study Completion
May 16, 2018
Last Updated
March 2, 2026
Results First Posted
October 27, 2021
Record last verified: 2026-02