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

Phase 4Not Yet RecruitingNCT07825142

Beijing Tsinghua Chang Gung Hospital160 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

160

Conditions

Postoperative Pain Nephrolithiasis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts