Anrikefon-based Patient-controlled Intravenous Analgesia After Laparoscopic Surgery

NCT07246785 | Terminated Phase 4

• 1 other identifier: 2025R0444
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Visceral Pain, Postoperative; Anrikefon; Patient-controlled Intravenous Analgesia; Laparoscopic Surgery

Keywords

Laparoscopic surgery; Visceral pain, Postoperative; Anrikefon; Patient-controlled intravenous analgesia

Outcome Measures

Primary Outcomes (1)

• Time-weighted sum of pain intensity difference (SPID) of movement-evoked visceral pain within 48 hours

  Time-weighted SPID is defined as the cumulative sum of the product obtained by multiplying the pain intensity difference at each time point (calculated by subtracting the baseline pain intensity score from the current pain intensity score) by the time difference (the current time point minus the previous time point). Movement-evoked visceral pain intensity will be assessed before intervention and at 0.5, 1, 2, 6, 12, 24, 36, and 48 hours after intervention using an 11-point Numeric Rating Scale (0 = no pain, 10 = the worst pain).

  Within 48 hours after intervention.

Secondary Outcomes (5)

• Time-weighted SPID of visceral pain at rest within 48 hours

  Within 48 hours after intervention.

• Time-weighted SPID of movement-evoked somatic pain within 48 hours

  Within 48 hours after intervention.

• Time-weighted SPID of somatic pain at rest within 48 hours

  Within 48 hours after intervention.

• Time-weighted SPID of movement-evoked overall pain within 48 hours

  Within 48 hours after intervention.

• Time-weighted SPID of overall pain at rest within 48 hours

  Within 48 hours after intervention.

Other Outcomes (9)

• Quality of recovery at 24 hours after surgery

  At the 24th hour after surgery.

• Number of patient-controlled analgesia (PCA) attempts within 48 hours after intervention

  Within 48 hours after intervention.

• Rate of rescue analgesia within 48 hours after intervention

  Within 48 hours after intervention.

Study Arms (4)

High-dose anrikefon group

EXPERIMENTAL

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.

Drug: High-dose anrikefon

Medium-dose anrikefon group

EXPERIMENTAL

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.

Drug: Medium-dose anrikefon

Low-dose anrikefon group

EXPERIMENTAL

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.

Drug: Low-dose anrikefon

Morphine group

ACTIVE COMPARATOR

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.

Drug: Morphine

Interventions

High-dose anrikefon DRUG

Patients in this group receive postoperative patient-controlled intravenous analgesia for 48 hours. The formula comprises anrikefon (10 μg/ml), diluted with normal saline to 100 ml. The analgesic pump is set to deliver an initial loading dose of 8 ml, followed by patient-controlled boluses of 4 ml with a 10-minute lockout interval and no background infusion.

Also known as: High-dose anrikefon-based patient-controlled analgesia

High-dose anrikefon group

Medium-dose anrikefon DRUG

Patients in this group receive postoperative patient-controlled intravenous analgesia for 48 hours. The formula comprises anrikefon (7.5 μg/ml), diluted with normal saline to 100 ml. The analgesic pump is set to deliver an initial loading dose of 8 ml, followed by patient-controlled boluses of 4 ml with a 10-minute lockout interval and no background infusion.

Also known as: Medium-dose anrikefon-based patient-controlled analgesia

Medium-dose anrikefon group

Low-dose anrikefon DRUG

Patients in this group receive postoperative patient-controlled intravenous analgesia for 48 hours. The formula comprises anrikefon (5 μg/ml), diluted with normal saline to 100 ml. The analgesic pump is set to deliver an initial loading dose of 8 ml, followed by patient-controlled boluses of 4 ml with a 10-minute lockout interval and no background infusion.

Also known as: Low-dose anrikefon-based patient-controlled analgesia

Low-dose anrikefon group

Morphine DRUG

Patients in this group receive postoperative patient-controlled intravenous analgesia for 48 hours. The formula comprises morphine (0.5 mg/ml), diluted with normal saline to 100 ml. The analgesic pump is set to deliver an initial loading dose of 8 ml, followed by patient-controlled boluses of 4 ml with a 10-minute lockout interval and no background infusion.

Also known as: Morphine-based patient-controlled analgesia

Morphine group

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (23)

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MeSH Terms

Conditions

Visceral Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

Nociceptive Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anaesthesiology

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 24, 2025
• Study Start: December 25, 2025
• Primary Completion: February 11, 2026
• Study Completion: March 11, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)