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NCT Number: NCT07825142

A Randomized, Double-Blind, Placebo-Controlled Trial of Anrikefon for Postoperative Analgesia After Percutaneous Nephrolithotomy

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.

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Key information

Conditions

Postoperative Pain Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrolithiasis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.9% Sodium Chloride Injection as Placebo

Drug

5 mL IV, administered 15-30 min before the end of surgery; identical in appearance to anrikefon; used as placebo comparator.

Anrikefon

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Cumulative sufentanil consumption

    Time frame: Postoperative hours 0-24 and 24-48

  2. Pain intensity by numeric rating scale (NRS), 0-10 score

    Time frame: Postoperative hours 0.5, 1, 2, 4, 8, 12, and 24

  3. Total and effective patient-controlled analgesia (PCA) bolus counts (number)

    Time frame: Within the first 24 hours after surgery

  4. PCA effective bolus ratio (%)

    Time frame: Within the first 24 hours after surgery

  5. Rate of patients requiring rescue analgesia (%)

    Time frame: Within the first 24 hours after surgery

  6. Number of rescue analgesic doses (count)

    Time frame: Within the first 24 hours after surgery

  7. Time to first flatus (hours)

    Time frame: From surgery until the date of first documented flatus, assessed up to 7 days after surgery

  8. Time to first ambulation (hours)

    Time frame: From surgery until the date of first ambulation, assessed up to 7 days after surgery

  9. Duration of postoperative hospital stay (days)

    Time frame: From surgery until the date of hospital discharge, assessed up to 7 days after surgery

  10. Analgesia satisfaction score (0-10)

    Time frame: At postoperative hour 24

  11. Serum creatinine and blood urea nitrogen (mg/dL)

    Time frame: Baseline (preoperative) and at postoperative hours 24, 48, and 72

  12. Estimated glomerular filtration rate (eGFR, mL/min/1.73 m²)

    Time frame: Baseline (preoperative) and at postoperative hours 24, 48, and 72

  13. Incidence of acute kidney injury per KDIGO criteria (%)

    Time frame: Baseline (preoperative) through postoperative hour 72

  14. Incidence of adverse events (%)

    Time frame: From study drug administration through postoperative hour 72

  15. Area under the curve of NRS scores over 24 hours (AUC₀-₂₄ₕ, score-hours)

    Time frame: Postoperative hours 0-24

Study contacts

Contact information is provided by the study sponsor or research team.

Haotian Wu, MD

CONTACT

[email protected]

+86 17600809297

Sponsors and collaborators

Lead sponsor

Beijing Tsinghua Chang Gung Hospital

Other

Registry information

Official study title

A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study of Anrikefon for Perioperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy (PCNL)

Acronym: ARK-PCNL

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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