Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery

Recruiting now · Phase 4

Conditions studied: Laparoscopic Surgery, Visceral Pain, Postoperative, Anrikefon, Patient-controlled Intravenous Analgesia

In brief

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.

Key facts

Study ID

NCT07525986

Run by

Peking University First Hospital

People needed

140

Starts

2026-04-14

Expected to finish

2027-04-01

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged >= 18 years but < 75 years;
• Scheduled to undergo elective laparoscopic colorectal 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.

You may not qualify if…

• Presence of preoperative cognitive impairment (Mini-Mental State Examination [MMSE] score < 27), or inability to communicate due to language barrier;
• Body mass index (BMI) > 30 kg/m² or < 18 kg/m²;
• Presence of poorly controlled or untreated comorbidities, including but not limited to the following: hypertension characterized by a resting systolic blood pressure (SBP) > 180 mmHg and/or diastolic blood pressure (DBP) > 110 mmHg, coronary artery disease with unstable angina or myocardial infarction within 6 months, heart failure rated as New York Heart Association classification >= III, severe chronic obstructive pulmonary disease (or in a state of acute exacerbation), severe hepatic insufficiency (Child-Pugh grade C), severe renal insufficiency (estimated glomerular filtration rate < 30 ml/min/1.73m²), or American Society of Anesthesiologists (ASA) physical status classification >= IV;
• Continuous use of opioid analgesics for more than 10 days for any reason, or alcohol abuse (average daily intake of pure alcohol > 36 g) within 3 months before screening;
• Preoperative use of opioid or non-opioid analgesics with the interval between the last administration and randomization shorter than five half-lives of the drug or the duration of drug action (whichever is longer);
• Known allergies or contraindications to opiates or other medications that may be used in this study, such as anesthetics, antiemetics, and nonsteroidal anti-inflammatory drugs (NSAIDs);
• Anticipated need for postoperative mechanical ventilation；
• Other conditions that are considered unsuitable for study participation.

Where it is running

• Peking University First Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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