New oral painkiller aims to ease recovery after orthopedic surgery

NCT ID NCT07699601

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This clinical trial tests an experimental painkiller called HL-1186 for people recovering from orthopedic surgery (bone or joint surgery). The study compares HL-1186 against a placebo (dummy pill) and a standard painkiller (oxycodone-acetaminophen) to see how well it controls pain and whether it is safe. Participants are adults aged 18 to 75 who are scheduled for orthopedic surgery under general anesthesia and are expected to have moderate to severe pain afterward. The main goal is to measure pain relief over the first 48 hours after taking the drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HL-1186
What this could lead to
If effective, HL-1186 could offer a new oral painkiller option for people recovering from orthopedic surgery, potentially with fewer side effects than current medications.
What could go wrong
This is a mid-stage trial with 330 participants, so results may not apply to everyone. The drug may prove no better than existing painkillers or cause unexpected side effects.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 330 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

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 75 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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 18 years old ≤ age ≤ 75 years old, gender is not limited. 2. 18 kg/m2 ≤ Body Mass Index (BMI) ≤ 30kg/m2. 3. Scheduled to undergo orthopedic surgery under general anesthesia, with expected moderate-to-severe postoperative pain intensity. 4. Able to understand the research process and the use of pain scales, and communicate effectively with researchers. 5. After surgery completion, the participant is judged by the investigator to be awake and has a resting NRS score ≥ 4. Exclusion Criteria: 1. Previous surgery on the same site that may affect pain perception at the surgical site. 2. Paresthesia or other pain that may affect postoperative pain evaluation or scale assessment. 3. Neuropsychological disorders that may affect postoperative pain evaluation or scale assessment. 4. Unstable angina, myocardial infarction, severe arrhythmia, NYHA cardiac function class ≥ III, or recurrent asthma attacks, etc., deemed unsuitable for inclusion by the investigator. 5. Poorly controlled hypertension. 6. Sleep apnea syndrome, or the presence of a difficult airway as assessed by the investigator. 7. 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. 8. 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. 9. Women who are pregnant or breastfeeding (within 1 year after delivery). 10. Participation in another drug or medical device trial within 1 month before screening, or currently participating in another clinical trial receiving investigational intervention. 11. Any other condition considered unsuitable for participation by the investigator.

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Conditions

The condition(s) this trial relates to.

Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • The Third Xiangya Hospital of Central South University, Changsha, Hunan

    RECRUITING

    Changsha, Hunan, China

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