Efficacy and Safety of Anrikefon Injection for the Treatment of Postoperative Pain in Patients Undergoing Laparoscopic Hepatectomy

NCT07826806 | Not Yet Recruiting Phase 2

• 1 other identifier: E20261121
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

Efficacy and safety of Anrikefon injection for the treatment of postoperative pain in patients undergoing laparoscopic hepatectomy--A single-center, randomized, controlled clinical study

Conditions

Pain Management

Keywords

Post-surgery，pain

Outcome Measures

Primary Outcomes (1)

• 1. Area under the NRS pain score curve 24 hours after medication (AUC-NRS24)

  24 hours after surgery

Secondary Outcomes (8)

• Pain intensity at rest and during movement (assess pain scores at 30 min, 1 h, 3 h, 6 h, 12 h, 24 h, 48 h, and 72 h after the first dose).

  0-72 hours after surgery

• Pain intensity difference (PID) at 30 min, 1, 3, 6, 12, 24, 48, and 72 h after dosing. Pain was assessed by NRS (0-10; 0=no pain, 10=severe pain). PID = baseline score (pre-dose/pre-op, 0 h) minus score at each time point. Unit: points.

  0-72 hours after surgery

• Sum of Pain Intensity Difference (SPID) at 30 min, 1, 3, 6, 12, 24, 48, and 72 h post-dose. NRS (0-10; 0=no pain, 10=worst pain) assessed pain. TPID = baseline score (pre-dose, 0 h) - score at each time point. Unit: points.

  0-72 hours after surgery

• Total Sufentanil dose administered via PCIA pump within 24 hours post-surgery. Measurement tool: PCIA pump (or electronic medical record). Measurement unit: micrograms (μg).

  24 hours after surgery

• Baseline, then assess NRS scores (visceral pain, incision pain, shoulder pain) at 30 min, 1 h, 3 h, 6 h, 12 h, 24 h, 48 h, and 72 h after the first dose.

  0-72 hours after surgery

Study Arms (2)

Anruikefen

EXPERIMENTAL

Drug: Anrikefon Injection

Flurbiprofen Ester

PLACEBO COMPARATOR

Drug: Flurbiprofen

Interventions

Anrikefon Injection DRUG

For patients undergoing laparoscopic liver resection, randomization is completed within 2 hours after surgery. Within 30 minutes after successful randomization, they receive their first injection of either Anruikefen or Flurbiprofen Ester. After the first dose, at 8±1h, 16±1h, 24±1h, 32±1h, 40±1h, 48±1h, 56±1h, and 64±1h, each participant is given a corresponding dose of Anruikefen IV infusion

Anruikefen

Flurbiprofen DRUG

For patients undergoing laparoscopic liver resection, randomization is completed within 2 hours after surgery. Within 30 minutes after successful randomization, they receive their first injection of either Anruikefen or Flurbiprofen Ester. After the first dose, at 8±1h, 16±1h, 24±1h, 32±1h, 40±1h, 48±1h, 56±1h, and 64±1h, each participant is given a corresponding dose of Flurbiprofen Ester IV infusion.

Flurbiprofen Ester

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years, any gender;
• American Society of Anesthesiologists (ASA) score of I or II;
• BMI between 18 kg/m² and 30 kg/m²;
• Patients scheduled for laparoscopic liver resection under general anesthesia, with surgery lasting less than 6 hours;
• Surgical incision less than 10 cm;
• Able to understand pain intensity assessment methods.
• Participants understand the purpose and procedures of this study, voluntarily participate, and sign a written informed consent form.

You may not qualify if:

• Patients allergic to opioids, flurbiprofen ester, or any other ingredients in the investigational drugs.
• Patients expected to use continuous epidural analgesia or local block analgesia during the treatment period.
• Patients with a history of gastrointestinal ulcers or bleeding who need treatment.
• Patients undergoing emergency surgery or trauma.
• Patients whose surgery needs to be converted to open abdominal surgery.
• Patients unwilling to use patient-controlled intravenous analgesia (PCIA).
• Patients with a history of upper abdominal surgery.
• Patients expected to require postoperative continued intubation.
• Patients needing postoperative admission to the ICU.
• Patients with any of the following disease history or evidence before screening:
• Severe cardiovascular or pulmonary diseases (myocardial infarction, heart failure, or respiratory failure).
• Neurological or psychiatric history: brain injury, intracranial hypertension, schizophrenia, mania, etc., judged by the investigator as not suitable for the study.
• History of digestive diseases: intestinal obstruction or other digestive system diseases that may cause nausea or vomiting as judged by the investigator; accompanied by other severe digestive tract issues affecting digestion (e.g., severe constipation, duodenal stasis syndrome, etc.), or other digestive diseases evaluated by the investigator as unsuitable for the study.
• Patients with obvious chronic dizziness or diagnosed vestibular function disorders (other than motion sickness), including but not limited to peripheral vestibular syndrome or central vestibular syndrome.
• Patients who received neoadjuvant treatment before surgery.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Conditions

Agnosia

Interventions

Flurbiprofen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Ping Chen, MD

CONTACT

13821017600; sly178604@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 17, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share