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
Efficacy and safety of Anrikefon injection for the treatment of postoperative pain in patients undergoing laparoscopic hepatectomy--A single-center, randomized, controlled clinical study
Participants understand the purpose and procedures of this study, voluntarily participate, and sign a written informed consent form.
Exclusion Criteria:
Drug: Anrikefon Injection
Drug: Flurbiprofen
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
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.
1. Area under the NRS pain score curve 24 hours after medication (AUC-NRS24)
Time frame: 24 hours after surgery
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
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
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
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
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
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
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
Incidence of nausea, vomiting, and PONV within 72 hours after the first dose
Time frame: 0-72 hours after surgery
No study locations are listed for this record.
Plan to share: No
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Tianjin Medical University Cancer Institute and Hospital