New shot may ease knee surgery pain, cut opioid use
NCT ID NCT03015532
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 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 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Postoperative pain are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two nerve blocks go head to head for chest surgery pain
- Can a Nurse's confidence ease a Patient's postoperative pain?
- Antidepressant may double as pain reliever after gallbladder surgery
- Nerve blocks put to the test for breast surgery pain
- A Non-Opioid pain drug takes aim at Surgery's opioid problem
- Can a nerve block stop pain months after hysterectomy?