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New Non-Opioid painkiller shows promise for knee surgery patients

NCT ID NCT03974932

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new non-opioid pain medicine called HTX-011 in 116 people having knee replacement surgery. Everyone received the medicine as part of a pain plan that did not include opioids. The goal was to see how well it controlled pain after surgery. The study is complete, and results may help reduce the need for strong opioid painkillers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

116 people

The number who actually took part.

Started

Jun 2019

Finished

Jan 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Is scheduled to undergo primary unilateral TKA under spinal anesthesia. * Has not previously undergone TKA in either knee. * Has an American Society of Anesthesiologists (ASA) Physical Status of I, II, or III. * Is able to walk at least 20 feet with 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 is at least 2 years post-menopausal; or is in a monogamous relationship with a partner who is surgically sterile; or using acceptable contraceptives. Exclusion Criteria: * Has a planned concurrent surgical procedure. * Has other pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain. * Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications. * Using or expected to use Factor IX Complex or anti-inhibitor coagulant concentrates during the study. * 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 with the exception of subjects on low-dose (≤100 mg) daily acetylsalicylic acid for cardioprotection. * 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 been administered any local anesthetic within 72 hours 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. * Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives. * 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. * 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. * Is currently undergoing treatment for hepatitis B, hepatitis C, or HIV. * Has uncontrolled anxiety, psychiatric, or neurological disorder that, in the opinion of the Investigator, might interfere with study assessments. * Has acquired defective color vision or acute gastrointestinal ulcers, either of which could interfere with scheduled study medications. * 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 nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix. * Has undergone 3 or more surgeries within 12 months. * Has a body mass index (BMI) \>39 kg/m2.

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Conditions

The condition(s) this trial relates to.

agnosia pain agnosia Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Endeavor Clinical Trials, LLC.

    San Antonio, Texas, 78229, United States

  • First Surgical Hospital

    Bellaire, Texas, 77401, United States

  • Helen Keller Hospital

    Sheffield, Alabama, 35660, United States

  • Midwest Clinical Research Center, LLC

    Dayton, Ohio, 45417, United States

  • Phoenix Clinical Research, LLC

    Tamarac, Florida, 33321, United States

  • Plano Surgical Hospital

    Plano, Texas, 75093, United States

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Other studies related to the condition(s) this trial covers.