New Non-Opioid painkiller shows promise for knee surgery patients
NCT ID NCT03974932
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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116 people
The number who actually took part.
- Started
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Jun 2019
- Finished
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Jan 2021
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Endeavor Clinical Trials, LLC.
San Antonio, Texas, 78229, United States
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First Surgical Hospital
Bellaire, Texas, 77401, United States
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Helen Keller Hospital
Sheffield, Alabama, 35660, United States
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Midwest Clinical Research Center, LLC
Dayton, Ohio, 45417, United States
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Phoenix Clinical Research, LLC
Tamarac, Florida, 33321, United States
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Plano Surgical Hospital
Plano, Texas, 75093, United States
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Other studies related to the condition(s) this trial covers.
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