Efficacy of Anrikefon-based Patient-controlled Intravenous Analgesia for Pain Management After Laparoscopic Surgery: a Randomized, Double-blind, Active-controlled Pilot Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 74
Healthy Volunteers: f
View:
• Aged ≥ 18 years but \< 75 years;
• Scheduled to undergo elective laparoscopic gastrointestinal surgery with an expected duration of ≥1 hour;
• The incisional pain can be covered by the transversus abdominis plane block or rectus sheath block; yet patients still require postoperative patient-controlled intravenous analgesia.
Locations
Other Locations
China
Peking University First Hospital
RECRUITING
Beijing
Contact Information
Primary
Dong-Xin Wang, MD, PhD
wangdongxin@hotmail.com
8610 83572784
Backup
Chun-Qing Li, MD
lichuntsing@163.com
8610 83575138
Time Frame
Start Date:2025-12-25
Estimated Completion Date:2026-11
Participants
Target number of participants:140
Treatments
Experimental: High-dose anrikefon group
Postoperative patient-controlled intravenous analgesia is established with anrikefon 1000 μg, diluted with normal saline to 100 ml, and programmed to administer an initial loading dose of 8 ml, followed by 4-ml boluses with a lockout interval of 10 minutes and no continuous background infusion.
Experimental: Medium-dose anrikefon group
Postoperative patient-controlled intravenous analgesia is established with anrikefon 750 μg, diluted with normal saline to 100 ml, and programmed to administer an initial loading dose of 8 ml, followed by 4-ml boluses with a lockout interval of 10 minutes and no continuous background infusion.
Experimental: Low-dose anrikefon group
Postoperative patient-controlled intravenous analgesia is established with anrikefon 500 μg, diluted with normal saline to 100 ml, and programmed to administer an initial loading dose of 8 ml, followed by 4-ml boluses with a lockout interval of 10 minutes and no continuous background infusion.
Active_comparator: Morphine group
Postoperative patient-controlled intravenous analgesia is established with morphine 50 mg, diluted with normal saline to 100 ml, and programmed to administer an initial loading dose of 8 ml, followed by 4-ml boluses with a lockout interval of 10 minutes and no continuous background infusion.