Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Analgesia in Orthopedic Surgery (NCT07699601) | Clinical Trial Compass
RecruitingPhase 2/3
Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Analgesia in Orthopedic Surgery
China330 participantsStarted 2026-05-09
Plain-language summary
This clinical trial is a multiple-center, randomized, double-blind, placebo- and active-controlled parallel-group Phase II/III clinical trial, to evaluate the efficacy and safety of HL-1186 Tablets for Postoperative Analgesia in Orthopedic Surgery.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18 years old ≤ age ≤ 75 years old, gender is not limited.
. 18 kg/m2 ≤ Body Mass Index (BMI) ≤ 30kg/m2.
. Scheduled to undergo orthopedic surgery under general anesthesia, with expected moderate-to-severe postoperative pain intensity.
. Able to understand the research process and the use of pain scales, and communicate effectively with researchers.
. After surgery completion, the participant is judged by the investigator to be awake and has a resting NRS score ≥ 4.
Exclusion criteria
. Previous surgery on the same site that may affect pain perception at the surgical site.
. Paresthesia or other pain that may affect postoperative pain evaluation or scale assessment.
. Neuropsychological disorders that may affect postoperative pain evaluation or scale assessment.
. Unstable angina, myocardial infarction, severe arrhythmia, NYHA cardiac function class ≥ III, or recurrent asthma attacks, etc., deemed unsuitable for inclusion by the investigator.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Sleep apnea syndrome, or the presence of a difficult airway as assessed by the investigator.
. Known allergy to any component of the investigational drug(s), to perioperative (from induction of anesthesia to completion of surgery) anesthetic/analgesic/antiemetic drugs, or a history of allergy to ≥ 3 substances.
. Positive for human immunodeficiency virus (HIV) antibody; positive for Treponema pallidum antibody and positive toluidine red unheated serum test (TRUST); positive for hepatitis B surface antigen (HBsAg) with detectable HBV-DNA; or positive for hepatitis C virus (HCV) antibody.