New injection could ease pain after bone surgery
NCT ID NCT07186426
First seen Jun 24, 2026 · Last updated Aug 27, 2026 · Updated 3 times
Summary
This study tests a new drug called HSK21542 for pain after hip replacement surgery. About 405 adults will receive either HSK21542, morphine, or a placebo. The goal is to see if HSK21542 reduces pain better and causes fewer side effects like nausea and vomiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HSK21542 injection
- What this could lead to
- If successful, this could provide a new option for managing pain after orthopedic surgery with potentially fewer side effects than current treatments.
- What could go wrong
- This is still an experimental drug. Even in Phase 3, it may not prove more effective or safer than existing painkillers like morphine. Side effects are possible.
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
-
405 people
The number who actually took part.
- Started
-
Aug 2025
- Finished
-
Feb 2026
- 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 to 74 years
- 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: * 18 years old ≤ age ≤74 years old, regardless of gender; * 18 kg/m2≤BMI≤32 kg/m2,meet the weight range specified in the protocol; * American Society of Anesthesiologists (ASA) grade ⅰ-ⅲ; * Accept hip replacement under general anesthesia; * Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time; * Fully understand and voluntarily participate this trial, and sign the informed consent form; Exclusion Criteria: * Patients with allergy to opioids or any component of the trial drug; * Patients with a history of severe cardiovascular and cerebrovascular diseases, ,and psychiatric disorders; * Last use of opioid or non-opioid analgesics less than 5 half-lives or the duration of drug efficacy prior to randomization; use of drugs with unclear half-lives that may affect analgesic efficacy within 7 days prior to randomization, or last use of drugs affecting analgesic efficacy less than 5 half-lives prior to randomization, as well as Chinese herbal medicines or proprietary Chinese medicines deemed by the investigator as potentially impacting the evaluation of efficacy and safety; * Continuous use of opioid analgesics for more than 7 days for any reason within 30 days prior to screening; * Laboratory test results during the screening period meeting any of the following criteria: 1) Significantly abnormal hematology results; 2) Significantly abnormal prothrombin time test results; 3) Significantly abnormal liver or kidney function; 4) Significantly abnormal fasting blood glucose; * Positive test results during the screening period for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody; * A history of drug, drug, and/or alcohol abuse; * Participate in any clinical trail within 30 days; * Pregnant or lactating female subjects; * Subjects of childbearing potential who are unwilling to use contraception throughout the study period or plan to become pregnant within 3 months after the study.; * Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Postoperative pain management are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Xiangya Hospital of Central South University
Changsha, Hunan, China
-
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Chest surgery pain study seeks best relief strategy
- New study tests two injections to ease knee surgery pain and cut opioid use
- Eye-Opening pain relief: pupillometer may cut opioid use after surgery
- Hip surgery pain relief: which nerve block method works best?
- New hip block could match standard for Post-Surgery pain relief
- Pain education may boost shoulder surgery recovery