Actively Recruiting

Phase 4
Age: 18Years - 75Years
All Genders
ID07525986

Efficacy of Anrikefon-based Patient-controlled Intravenous Analgesia for Pain Management After Laparoscopic Surgery: a Randomized, Double-blind, Active-controlled Pilot Trial

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

140

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of anrikefon, a new type of pain medicine that targets specific receptors related to visceral pain, for managing pain after laparoscopic surgery. This study focuses on patients undergoing laparoscopic colorectal surgery, aiming to find the best dose of anrikefon given through a patient-controlled intravenous analgesia (PCIA) pump. The goal is to specifically reduce visceral pain, which is often underestimated and not well controlled by usual pain medicines like morphine. Participants will receive postoperative pain management with one of four treatments: high-dose anrikefon, medium-dose anrikefon, low-dose anrikefon, or morphine. Each treatment is delivered via a PCIA pump programmed to give an initial dose followed by patient-controlled bolus doses with a lockout period, over 48 hours. The treatments are combined with other pain control methods like nerve blocks for somatic pain and nonsteroidal anti-inflammatory drugs (NSAIDs) for inflammatory pain as part of a multimodal approach. During the study, participants will be monitored closely for pain levels at rest and with movement over 48 hours after surgery using pain intensity measures. Researchers will assess the area under the curve (AUC) of visceral and overall pain to evaluate effectiveness. Safety and side effects will also be observed. The study is designed as a randomized, double-blind, active-controlled trial, helping determine the feasibility of a larger future study and optimal dosing for anrikefon in this setting.

CONDITIONS

Brief 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 at least 1 hour
  • Incisional pain planned to be managed by transversus abdominis plane block or rectus sheath block
  • Requires postoperative patient-controlled intravenous analgesia
Not Eligible

You will not qualify if you...

  • Preoperative cognitive impairment (Mini-Mental State Examination score less than 27) or inability to communicate due to language barrier
  • Body mass index (BMI) greater than 30 kg/m² or less than 18 kg/m²
  • Poorly controlled or untreated major health conditions such as severe hypertension, unstable coronary artery disease, advanced heart failure, severe lung disease, severe liver or kidney failure, or ASA physical status classification IV or higher
  • Continuous opioid use for more than 10 days or recent alcohol abuse
  • Recent use of opioid or non-opioid analgesics with insufficient time since last dose
  • Known allergies or contraindications to opioids, anesthetics, antiemetics, or NSAIDs
  • Anticipated need for postoperative mechanical ventilation
  • Any other condition deemed unsuitable for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 48 hours

Participants receive patient-controlled intravenous analgesia with anrikefon or morphine following laparoscopic surgery to manage postoperative pain.

1 baseline visit and continuous use of analgesic pump for 48 hours

Trial Site Locations

Total: 1 location

1

Peking University First Hospital

Beijing, Beijing Municipality, China, 100034

Actively Recruiting

Loading map...

Research Team

D

Dong-Xin Wang, MD, PhD

C

Chun-Qing Li, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

4

Similar Trials

Comparison of Postoperative Analgesic Efficacy of Ultrasonog...

Laparoscopic Surgery

Actively Recruiting

1 location

Evaluation of Intra-operative Photographs for the Assessment...

Gastric Cancer

Actively Recruiting

8 locations

Impact of Recruitment Maneuvers and PEEP-guided Electrical I...

Laparoscopic Surgery

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Phase I clinical trial evaluating the safety, tolerance, pharmacokinetics and pharmacodynamics of HSK21542 injection in healthy volunteers.

Rong Shao, Hai-Ying Wang, Zou-Rong Ruan...

https://pubmed.ncbi.nlm.nih.gov/39397291

Antinociceptive and Antipruritic Effects of HSK21542, a Peripherally-Restricted Kappa Opioid Receptor Agonist, in Animal Models of Pain and Itch.

Xin Wang, Xiaoli Gou, Xiaojuan Yu...

https://pubmed.ncbi.nlm.nih.gov/34867403

Effect of Intravenous Oxycodone in Combination With Different Doses of Dexmedetomdine on Sleep Quality and Visceral Pain in Patients After Abdominal Surgery: A Randomized Study.

Zongming Jiang, Guozhong Zhou, Qiliang Song...

https://pubmed.ncbi.nlm.nih.gov/30134283

Comparison of Analgesic and Adverse Effects of Oxycodone- and Fentanyl-Based Patient-Controlled Analgesia in Patients Undergoing Robot-Assisted Laparoscopic Gastrectomy Using a 55:1 Potency Ratio of Oxycodone to Fentanyl: A Retrospective Study.

Jae Chul Koh, Hee Jung Kong, Myoung Hwa Kim...

https://pubmed.ncbi.nlm.nih.gov/32943912

Application of Vitamin E Acetate on Staple Lines and Anastomoses of Roux-en-Y Gastric Bypass: Impact on Postoperative Pain and Acute Phase Reactants.

Jaime Ruiz-Tovar, Alejandro Garcia, Carlos Ferrigni...

https://pubmed.ncbi.nlm.nih.gov/32342266