New painkiller could ease recovery after bone surgery
NCT ID NCT07353996
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a single injection of tegileridine fumarate, a new painkiller, for adults recovering from orthopedic surgeries like spinal fusion or knee replacement. Researchers aim to find the dose that works for 90% of patients without causing too many side effects. 180 participants will receive different doses to see which provides the best pain relief with the fewest problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tegileridine fumarate (a painkiller)
- What this could lead to
- If successful, this could establish a safe, effective single dose of tegileridine for managing pain after common orthopedic surgeries, improving recovery.
- What could go wrong
- This is a small, early-phase dose-finding study, not a large efficacy trial. The drug may cause side effects like nausea or breathing problems, and the optimal dose may not work for everyone.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 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: * Adults aged 18 to 75 years. * Scheduled for elective orthopedic surgery, including spinal fusion, femoral fracture fixation, or total knee arthroplasty. * American Society of Anesthesiologists (ASA) physical status I-III. * Ability to understand the study procedures and provide written informed consent. Exclusion Criteria: * Patients with moderate to severe obesity (BMI \> 30 kg/m²). * Known hypersensitivity or allergy to tegileridine fumarate or other analgesics. * History of chronic pain or long-term use of opioids. * Severe hepatic or renal impairment. * Patients requiring postoperative ICU care. * Severe respiratory depression (e.g., oxygen saturation \< 90%). * Known or suspected gastrointestinal obstruction, including paralytic ileus.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Locations
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The Second Affiliated Hospital of Zhejiang University anesthesiology department
RECRUITINGHanzhong, Zhejiang, 3100000, China
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