Actively Recruiting

Phase 4
Age: 18Years - 75Years
All Genders
NCT07525986

Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery

Led by Peking University First Hospital · Updated on 2026-04-24

140

Participants Needed

1

Research Sites

50 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Visceral pain following laparoscopic surgery is frequently underestimated, yet it is associated with a range of adverse outcomes. Effective visceral pain management should constitute an essential component of postoperative analgesic strategies following laparoscopic procedures. However, conventional analgesic agents, including μ-opioid receptor agonists, lack specificity for visceral pain. Anrikefon, a novel selective peripheral κ-opioid receptor agonist, demonstrates unique efficacy in alleviating visceral pain with a favorable safety profile. Preliminary studies showed that a single intravenous dose of anrikefon effectively alleviates postoperative pain after abdominal surgery with a low risk of adverse effects. The investigators hypothesize that an appropriate dosing regimen of anrikefon administered via patient-controlled intravenous analgesia (PCIA) pump, as part of a multimodal analgesic strategy, can specifically target and alleviate visceral pain after laparoscopic surgery, thereby achieving comprehensive postoperative analgesia.

CONDITIONS

Official Title

Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older but younger than 75 years
  • Scheduled for elective laparoscopic colorectal surgery lasting 1 hour or more
  • Incisional pain covered by transversus abdominis plane block or rectus sheath block but still needing postoperative patient-controlled intravenous analgesia
Not Eligible

You will not qualify if you...

  • Preoperative cognitive impairment (Mini-Mental State Examination score below 27) or inability to communicate due to language barriers
  • Body mass index over 30 kg/m² or under 18 kg/m²
  • Poorly controlled or untreated comorbidities such as severe hypertension, recent unstable angina or heart attack, severe heart failure, severe lung disease, severe liver or kidney failure, or very high anesthesia risk
  • Continuous opioid use for more than 10 days or alcohol abuse within 3 months before screening
  • Recent use of opioid or non-opioid analgesics without sufficient time before randomization
  • Known allergies or contraindications to opioids, anesthetics, antiemetics, or NSAIDs
  • Expected need for postoperative mechanical ventilation
  • Other conditions deemed unsuitable for participation

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking University First Hospital

Beijing, Beijing Municipality, China, 100034

Actively Recruiting

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Research Team

D

Dong-Xin Wang, MD, PhD

CONTACT

C

Chun-Qing Li, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

4

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