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New shot may ease knee surgery pain, cut opioid use

NCT ID NCT03015532

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 pain-relieving medicine called HTX-011 in 285 people having knee replacement surgery. The medicine was injected into the surgical area to see if it could reduce pain and the need for strong opioid painkillers. The goal was to find a safer, more effective way to manage pain after surgery.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

285 people

The number who actually took part.

Started

Jan 2017

Finished

May 2018

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 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.

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Conditions

The condition(s) this trial relates to.

Pain, Postoperative

As listed by the trial registrant

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

Contacts and locations

Locations

  • Study site

    Mobile, Alabama, 36608, United States

  • Study site

    Sheffield, Alabama, 35660, United States

  • Study site

    Phoenix, Arizona, 85015, United States

  • Study site

    Phoenix, Arizona, 85023, United States

  • Study site

    La Jolla, California, 92037, United States

  • Study site

    Riverside, California, 92503, United States

  • Study site

    San Diego, California, 92103, United States

  • Study site

    Miami, Florida, 33136, United States

  • Study site

    Miami, Florida, 33143, United States

  • Study site

    Miami, Florida, 33155, United States

  • Study site

    Tamarac, Florida, 33321, United States

  • Study site

    Las Vegas, Nevada, 89109, United States

  • Study site

    Columbus, Ohio, 43203, United States

  • Study site

    Columbus, Ohio, 43210, United States

  • Study site

    Dayton, Ohio, 45417, United States

  • Study site

    Bellaire, Texas, 77401, United States

  • Study site

    Houston, Texas, 77004, United States

  • Study site

    Houston, Texas, 77027, United States

  • Study site

    Houston, Texas, 77043, United States

  • Study site

    Plano, Texas, 75093, United States

  • Study site

    San Antonio, Texas, 78209, United States

  • Study site

    San Antonio, Texas, 78229, United States

  • Study site

    San Antonio, Texas, 78240, United States

  • Study site

    Webster, Texas, 77598, United States

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