New injection could ease pain after hip surgery
NCT ID NCT07442877
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new pain-relief injection called HSK21542 in 161 adults who had hip replacement surgery. The goal was to see if it works better than a placebo or morphine at reducing pain after the operation. The results could lead to a new option for managing pain after orthopedic surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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161 people
The number who actually took part.
- Started
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Sep 2024
- Finished
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Jan 2025
- 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
-
18 to 74 years
- 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: * 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 1-3; * 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.
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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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Xiangya Hospital of Central South University
Changsha, Hunan, China
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