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Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT03015532•Heron Therapeutics

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+8 more criteria

Locations (24)

Mobile, Alabama, United States

Sheffield, Alabama, United States

Phoenix, Arizona, United States

La Jolla, California, United States

Riverside, California, United States

San Diego, California, United States

Miami, Florida, United States

Key Dates

Start Date

January 13, 2017

Primary Completion Date

April 20, 2018

Completion Date

May 16, 2018

Last Updated

March 2, 2026

Enrollment

285

ACTUAL participants

Conditions

Postoperative Pain

Interventions

HTX-011

DRUG

Saline Placebo

DRUG

Bupivicaine HCl

DRUG

Ropivacaine

DRUG

QIPB in Inguinal Hernia

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Postoperative Pain

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RECRUITINGNA

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NCT07436806

Chronic Post-thoracotomy PainNeuropathic Pain+1 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia

Inclusion Criteria

Exclusion Criteria

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