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

ConditionPain Management
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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.

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: AnruikefenExperimental treatment 1 intervention
Group B: Flurbiprofen EsterPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: