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

NCT07825142 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 27024-0-01
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

Anrikefon; Percutaneous Nephrolithotomy; PCNL; Opioid-related adverse events; Perioperative analgesia; Peripheral kappa opioid receptor agonist; Multimodal analgesia

Outcome Measures

Primary Outcomes (1)

• Incidence of composite opioid-related adverse events (ORAEs) within 24 h after surgery

  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

  Postoperative hours 0-24 and 24-48

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

  Postoperative hours 0.5, 1, 2, 4, 8, 12, and 24

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

  Within the first 24 hours after surgery

• PCA effective bolus ratio (%)

  Within the first 24 hours after surgery

• Rate of patients requiring rescue analgesia (%)

  Within the first 24 hours after surgery

Study Arms (2)

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.

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.

Drug: 0.9% Sodium Chloride Injection as Placebo

Interventions

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.

Placebo

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.

Anrikefon

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

MeSH Terms

Conditions

Pain, Postoperative; Nephrolithiasis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Haotian Wu, MD

CONTACT

+86 17600809297; tatabox@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pharmacists preparing the study drug are unblinded but do not participate in outcome assessment; all other personnel listed above are blinded to allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Department of Anesthesiology

Model Details: Two parallel arms (anrikefon vs. placebo) with 1:1 allocation, stratified block randomization.

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 17, 2026
• Study Start (Estimated): October 12, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share