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Not yet recruitingNCT07826806Updated Sep 17, 2026

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

A Phase 2 interventional study of Anrikefon Injection and Flurbiprofen in Pain Management, sponsored by Tianjin Medical University Cancer Institute and Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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

02

Conditions studied

  • Pain Management

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Keywords

  • Post-surgery,pain
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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age between 18 and 75 years, any gender;
  2. American Society of Anesthesiologists (ASA) score of I or II;
  3. BMI between 18 kg/m² and 30 kg/m²;
  4. Patients scheduled for laparoscopic liver resection under general anesthesia, with surgery lasting less than 6 hours;
  5. Surgical incision less than 10 cm;
  6. 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.

Exclusion criteria

Exclusion Criteria:

  1. Patients allergic to opioids, flurbiprofen ester, or any other ingredients in the investigational drugs.
  2. Patients expected to use continuous epidural analgesia or local block analgesia during the treatment period.
  3. Patients with a history of gastrointestinal ulcers or bleeding who need treatment.
  4. Patients undergoing emergency surgery or trauma.
  5. Patients whose surgery needs to be converted to open abdominal surgery.
  6. Patients unwilling to use patient-controlled intravenous analgesia (PCIA).
  7. Patients with a history of upper abdominal surgery.
  8. Patients expected to require postoperative continued intubation.
  9. Patients needing postoperative admission to the ICU.
  10. Patients with any of the following disease history or evidence before screening:
  11. Severe cardiovascular or pulmonary diseases (myocardial infarction, heart failure, or respiratory failure).
  12. Neurological or psychiatric history: brain injury, intracranial hypertension, schizophrenia, mania, etc., judged by the investigator as not suitable for the study.
  13. 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.
  14. 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.
  15. Patients who received neoadjuvant treatment before surgery.
  16. Patients who experienced nausea, retching, or vomiting within 24 hours before anesthesia induction (excluding bowel prep-related cases).
  17. Known allergy or contraindication to other anesthetics or antiemetics that may be used during the trial.
  18. Patients who used drugs with unclear half-lives that have analgesic or antiemetic effects within 14 days before randomization, or whose last use was less than 5 half-lives or the drug's effective duration (whichever is longer), including but not limited to opioids, non-opioid analgesics, antiemetics (or drugs with antiemetic effects), sedatives, anesthetics, corticosteroids, and other similar drugs.
  19. Patients needing dialysis or who have alcoholism during treatment.
  20. Pregnant or breastfeeding women, or those planning pregnancy during the study period or within 3 months after study completion.
  21. Subjects the investigator believes have any other factor making them unsuitable for this clinical study.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
108 participants (estimated)

Study arms

  • Experimental
    Anruikefen

    Drug: Anrikefon Injection

  • Placebo comparator
    Flurbiprofen Ester

    Drug: Flurbiprofen

Interventions

  • DrugAnrikefon Injection

    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

  • DrugFlurbiprofen

    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.

05

What researchers measure

Primary outcomes

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

    Time frame: 24 hours after surgery

Secondary outcomes

  1. 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).

    Time frame: 0-72 hours after surgery

  2. 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.

    Time frame: 0-72 hours after surgery

  3. 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.

    Time frame: 0-72 hours after surgery

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

    Time frame: 24 hours after surgery

  5. 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.

    Time frame: 0-72 hours after surgery

  6. Use of rescue pain medication: cumulative usage of rescue pain medication (morphine injection mg) at 072h after the first dose

    Time frame: 0-72 hours after surgery

  7. The proportion of patients needing rescue pain relief within 72 hours after the first dose and the total amount of rescue medication used

    Time frame: 0-72 hours after surgery

  8. Incidence of nausea, vomiting, and PONV within 72 hours after the first dose

    Time frame: 0-72 hours after surgery

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07826806
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Responsible party
Sponsor
First posted
Sep 17, 2026
Start date
Sep 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Sep 17, 2026

Study contacts

Ping Chen, MD
Contact
sly178604@126.com
13821017600

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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