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Can a single drug dose curb opioid side effects after kidney stone surgery?

NCT ID NCT07825142

Symptom relief Sponsor: Beijing Tsinghua Chang Gung Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers test whether a single intravenous dose of anrikefon, given near the end of kidney stone removal surgery, can reduce opioid-related side effects such as nausea, vomiting, itching, oversedation, and breathing problems in the first 24 hours after surgery. All 160 adult participants receive standard pain control with flurbiprofen axetil and a sufentanil patient-controlled pump. Half also receive anrikefon and half receive a saline placebo, assigned randomly, with neither patients nor doctors knowing who gets which. The trial follows pain scores, opioid use, recovery, satisfaction, kidney function, and side effects for up to 3 days after surgery.

What this could mean

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

Active substance
anrikefon, an experimental pain medicine given intravenously
What this could lead to
If it works, anrikefon could become a way to cut opioid side effects after kidney stone surgery while keeping pain controlled.
What could go wrong
This is a single-center Phase 4 trial in 160 adults, so results may not apply to other hospitals or patients. Anrikefon may not reduce side effects, and it could cause unexpected reactions.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 160 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

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: * Age 18-75 years, either sex * Scheduled elective unilateral percutaneous nephrolithotomy (PCNL) under general anesthesia (stone diameter \>2 cm, meeting PCNL indications) * ASA classification I-III * Body mass index (BMI) 18-35 kg/m2 * Preoperative estimated glomerular filtration rate (eGFR) \>=60 mL/min/1.73 m2 * Resting pain NRS score \<=2 within 24 h before surgery * Voluntary participation with written informed consent signed by the patient * Ability to cooperate with postoperative pain assessment, follow-up and examinations Exclusion Criteria: * Allergy to anrikefon, sufentanil, flurbiprofen axetil or their excipients * Use of opioids, NSAIDs, glucocorticoids or other analgesics within 7 days before surgery * Renal dysfunction (eGFR \<60 mL/min/1.73 m2) or severe hepatic dysfunction (ALT/AST \>3 times upper limit of normal) * Severe cardiovascular or respiratory disease (e.g., COPD, respiratory failure) * History of gastrointestinal ulcer or bleeding, or coagulation disorders * Pregnant or lactating women * History of cognitive impairment or drug/alcohol dependence * Concurrent participation in other clinical trials

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Conditions

The condition(s) this trial relates to.

nephrolithiasis Pain, Postoperative

As listed by the trial registrant

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

Nephrolithiasis Postoperative pain

How to take part

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