Patient-controlled IV anrikefon for pain after laparoscopic colorectal surgery

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

This trial tests whether patient-controlled intravenous anrikefon, given in different doses alongside standard nerve blocks, can better relieve visceral postoperative pain in adults having elective laparoscopic colorectal surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking University First Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07525986 on ClinicalTrials.gov

What this trial studies

In this Phase 4 interventional study, adults undergoing elective laparoscopic colorectal surgery who receive a transversus abdominis plane or rectus sheath block will be given patient-controlled intravenous analgesia (PCIA) delivering low, medium, or high doses of anrikefon or morphine. Participants will use the PCIA pump for postoperative pain control and investigators will record pain intensity, opioid consumption, adverse events, and recovery measures during the early postoperative period. Anrikefon is a selective peripheral κ-opioid receptor agonist thought to preferentially relieve visceral pain with fewer central opioid side effects. The study aims to identify an effective PCIA dosing regimen for anrikefon as part of a multimodal analgesic strategy after laparoscopic procedures.

Who should consider this trial

Good fit: Adults aged 18–74 scheduled for elective laparoscopic colorectal surgery lasting at least one hour who will receive a transversus abdominis plane or rectus sheath block and require postoperative PCIA may be eligible.

Not a fit: Patients with significant cognitive impairment, BMI outside 18–30 kg/m², poorly controlled major comorbidities, recent unstable cardiac disease, or those having non-colorectal or shorter laparoscopic procedures are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this could give patients more targeted relief of visceral postoperative pain with fewer traditional opioid side effects and potentially faster recovery.

How similar studies have performed: Preliminary studies reported that a single intravenous dose of anrikefon reduced postoperative visceral pain after abdominal surgery with a low rate of adverse effects, but using anrikefon in a PCIA regimen is a newer application that needs testing.

Eligibility criteria

Inclusion Criteria:

1. Aged \>= 18 years but \< 75 years;
2. Scheduled to undergo elective laparoscopic colorectal surgery with an expected duration of \>=1 hour;
3. 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.

Exclusion Criteria:

1. Presence of preoperative cognitive impairment (Mini-Mental State Examination \[MMSE\] score \< 27), or inability to communicate due to language barrier;
2. Body mass index (BMI) \> 30 kg/m² or \< 18 kg/m²;
3. 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;
4. 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;
5. 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);
6. 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);
7. Anticipated need for postoperative mechanical ventilation；
8. Other conditions that are considered unsuitable for study participation.

Where this trial is running

Beijing, Beijing Municipality

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

Study contacts

• Principal investigator: Dong-Xin Wang, MD, PhD — Peking University First Hospital
• Study coordinator: Dong-Xin Wang, MD, PhD

Conditions Laparoscopic Surgery; Visceral Pain, Postoperative; Anrikefon; Patient-controlled Intravenous Analgesia; Laparoscopic surgery; Visceral pain, Postoperative; Patient-controlled intravenous analgesia