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

Study acronym: ARK-PCNL
StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07825142
Lead Sponsor Beijing Tsinghua Chang Gung Hospital
Conditions
(from sponsor)		 Postoperative Pain, Nephrolithiasis
Related terms Nephrolithiasis, Postoperative Pain
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov