Postoperative PainPhase 4ARK-PCNLNCT07825142
A Randomized, Double-Blind, Placebo-Controlled Trial of Anrikefon for Postoperative Analgesia After Percutaneous Nephrolithotomy
A Phase 4 study testing Anrikefon in people with Postoperative Pain and Nephrolithiasis, run by Beijing Tsinghua Chang Gung Hospital.
Trial summary
This study evaluates whether a single dose of anrikefon, given intravenously shortly before the end of kidney stone removal surgery (PCNL), can reduce opioid-related side effects such as nausea, vomiting, itching, oversedation, and breathing problems in the first 24 hours after surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain, Nephrolithiasis
- What is being tested?
- Anrikefon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 12 Oct 2026to 30 Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study of Anrikefon for Perioperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy (PCNL)
This study evaluates whether a single dose of anrikefon, given intravenously shortly before the end of kidney stone removal surgery (PCNL), can reduce opioid-related side effects such as nausea, vomiting, itching, oversedation, and breathing problems in the first 24 hours after surgery. All participants receive the same standard pain control regimen (flurbiprofen axetil plus a sufentanil patient-controlled pump). In addition, half receive anrikefon and half receive a placebo (saline), decided by random allocation, with neither patients nor doctors knowing who receives which. A total of 160 adults (18-75 years) undergoing elective PCNL at Beijing Tsinghua Changgung Hospital will take part. Pain scores, opioid use, recovery, satisfaction, kidney function and side effects will be followed for up to 3 days after surgery.
- Conditions
- Postoperative Pain, Nephrolithiasis
- Being tested
- 0.9% Sodium Chloride Injection as Placebo, Anrikefon
- Keywords
- Anrikefon, Percutaneous Nephrolithotomy, PCNL, Opioid-related adverse events, Perioperative analgesia, Peripheral kappa opioid receptor agonist, Multimodal analgesia
- Medical subject headings
- Pain, Postoperative, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% Sodium Chloride Injection as PlaceboDrug
5 mL IV, administered 15-30 min before the end of surgery; identical in appearance to anrikefon; used as placebo comparator.
AnrikefonDrug
Single IV dose of anrikefon 0.1 mg diluted to 5 mL with 0.9% saline, administered 15-30 min before the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Anrikefon | Experimental | Anrikefon 0.1 mg IV (diluted to 5 mL) 15-30 min before the end of surgery, added to standard multimodal analgesia: flurbiprofen axetil 50 mg IV plus sufentanil PCIA. Receives: Drug: Anrikefon |
| Placebo | Placebo comparator | 0.9% saline 5 mL IV 15-30 min before the end of surgery, identical in appearance, added to the same standard multimodal analgesia: flurbiprofen axetil 50 mg IV plus sufentanil PCIA. Receives: Drug: 0.9% Sodium Chloride Injection as Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of composite opioid-related adverse events (ORAEs) within 24 h after surgery
Measured: Postoperative hours 0-6, 6-12, and 12-24; composite endpoint assessed over the 24-hour period immediately after surgery
Secondary outcomes (15)
Cumulative sufentanil consumption
Measured: Postoperative hours 0-24 and 24-48
Pain intensity by numeric rating scale (NRS), 0-10 score
Measured: Postoperative hours 0.5, 1, 2, 4, 8, 12, and 24
Total and effective patient-controlled analgesia (PCA) bolus counts (number)
Measured: Within the first 24 hours after surgery
PCA effective bolus ratio (%)
Measured: Within the first 24 hours after surgery
Rate of patients requiring rescue analgesia (%)
Measured: Within the first 24 hours after surgery
Number of rescue analgesic doses (count)
Measured: Within the first 24 hours after surgery
Time to first flatus (hours)
Measured: From surgery until the date of first documented flatus, assessed up to 7 days after surgery
Time to first ambulation (hours)
Measured: From surgery until the date of first ambulation, assessed up to 7 days after surgery
Duration of postoperative hospital stay (days)
Measured: From surgery until the date of hospital discharge, assessed up to 7 days after surgery
Analgesia satisfaction score (0-10)
Measured: At postoperative hour 24
Serum creatinine and blood urea nitrogen (mg/dL)
Measured: Baseline (preoperative) and at postoperative hours 24, 48, and 72
Estimated glomerular filtration rate (eGFR, mL/min/1.73 m²)
Measured: Baseline (preoperative) and at postoperative hours 24, 48, and 72
Incidence of acute kidney injury per KDIGO criteria (%)
Measured: Baseline (preoperative) through postoperative hour 72
Incidence of adverse events (%)
Measured: From study drug administration through postoperative hour 72
Area under the curve of NRS scores over 24 hours (AUC₀-₂₄ₕ, score-hours)
Measured: Postoperative hours 0-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start12 Oct 2026 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel arms (anrikefon vs. placebo) with 1:1 allocation, stratified block randomization.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhifeng Gao, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825142
- Sponsor's protocol ID
- 27024-0-01
- Other IDs
- 27024-0-01
- Acronym
- ARK-PCNL
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient privacy considerations; de-identified aggregate results will be published in peer-reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study of Anrikefon for Perioperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy (PCNL)
- ClinicalTrials.gov ID
- NCT07825142
- Acronym / sponsor ID
- ARK-PCNL / 27024-0-01
- Conditions
- Postoperative Pain, Nephrolithiasis
- Keywords
- Anrikefon, Percutaneous Nephrolithotomy, PCNL, Opioid-related adverse events, Perioperative analgesia, Peripheral kappa opioid receptor agonist, Multimodal analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 12 Oct 2026 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates whether a single dose of anrikefon, given intravenously shortly before the end of kidney stone removal surgery (PCNL), can reduce opioid-related side effects such as nausea, vomiting, itching, oversedation, and breathing problems in the first 24 hours after surgery. All participants receive the same standard pain control regimen (flurbiprofen axetil plus a sufentanil patient-controlled pump). In addition, half receive anrikefon and half receive a placebo (saline), decided by random allocation, with neither patients nor doctors knowing who receives which. A total of 160 adults (18-75 years) undergoing elective PCNL at Beijing Tsinghua Changgung Hospital will take part. Pain scores, opioid use, recovery, satisfaction, kidney function and side effects will be followed for up to 3 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel arms (anrikefon vs. placebo) with 1:1 allocation, stratified block randomization.
| Arm | Type | Receives |
|---|---|---|
| Anrikefon | Experimental | Drug: AnrikefonAnrikefon 0.1 mg IV (diluted to 5 mL) 15-30 min before the end of surgery, added to standard multimodal analgesia: flurbiprofen axetil 50 mg IV plus sufentanil PCIA. |
| Placebo | Placebo comparator | Drug: 0.9% Sodium Chloride Injection as Placebo0.9% saline 5 mL IV 15-30 min before the end of surgery, identical in appearance, added to the same standard multimodal analgesia: flurbiprofen axetil 50 mg IV plus sufentanil PCIA. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.9% Sodium Chloride Injection as Placebo5 mL IV, administered 15-30 min before the end of surgery; identical in appearance to anrikefon; used as placebo comparator. | Drug | Placebo |
| AnrikefonSingle IV dose of anrikefon 0.1 mg diluted to 5 mL with 0.9% saline, administered 15-30 min before the end of surgery. | Drug | Anrikefon |
Primary outcome
Incidence of composite opioid-related adverse events (ORAEs) within 24 h after surgery
Time frame: Postoperative hours 0-6, 6-12, and 12-24; composite endpoint assessed over the 24-hour period immediately after surgery
15 secondary outcomes
Cumulative sufentanil consumption
Time frame: Postoperative hours 0-24 and 24-48
Pain intensity by numeric rating scale (NRS), 0-10 score
Time frame: Postoperative hours 0.5, 1, 2, 4, 8, 12, and 24
Total and effective patient-controlled analgesia (PCA) bolus counts (number)
Time frame: Within the first 24 hours after surgery
PCA effective bolus ratio (%)
Time frame: Within the first 24 hours after surgery
Rate of patients requiring rescue analgesia (%)
Time frame: Within the first 24 hours after surgery
Number of rescue analgesic doses (count)
Time frame: Within the first 24 hours after surgery
Time to first flatus (hours)
Time frame: From surgery until the date of first documented flatus, assessed up to 7 days after surgery
Time to first ambulation (hours)
Time frame: From surgery until the date of first ambulation, assessed up to 7 days after surgery
Duration of postoperative hospital stay (days)
Time frame: From surgery until the date of hospital discharge, assessed up to 7 days after surgery
Analgesia satisfaction score (0-10)
Time frame: At postoperative hour 24
Serum creatinine and blood urea nitrogen (mg/dL)
Time frame: Baseline (preoperative) and at postoperative hours 24, 48, and 72
Estimated glomerular filtration rate (eGFR, mL/min/1.73 m²)
Time frame: Baseline (preoperative) and at postoperative hours 24, 48, and 72
Incidence of acute kidney injury per KDIGO criteria (%)
Time frame: Baseline (preoperative) through postoperative hour 72
Incidence of adverse events (%)
Time frame: From study drug administration through postoperative hour 72
Area under the curve of NRS scores over 24 hours (AUC₀-₂₄ₕ, score-hours)
Time frame: Postoperative hours 0-24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient privacy considerations; de-identified aggregate results will be published in peer-reviewed journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anrikefon in people with Postoperative Pain and Nephrolithiasis, run by Beijing Tsinghua Chang Gung Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haotian Wu, MD (+86 17600809297, tatabox@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of composite opioid-related adverse events (ORAEs) within 24 h after surgery (time frame: Postoperative hours 0-6, 6-12, and 12-24; composite endpoint assessed over the 24-hour period immediately after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.