Safety and Efficacy of Anricfen for Postoperative Analgesia and Rehabilitation Promotion After Pancreaticoduodenectomy.Intervention Measures: For Normal Adults, Administer Ariceptin Injection Intravenously Post-operation at a Dose of 1 μg/Kgevery 8 Hours for Three Consecutive Days After Surgery.

The Safety and Efficacy of Aniracetamfen for Postoperative Analgesia and Rehabilitation After Pancreaticoduodenectomy: A Single-center, Single-arm Clinical Study

Exploring the effectiveness and safety of early use of Ariceptinfen after pancreaticoduodenectomy in alleviating postoperative pain and promoting recovery of patients.

Main objective: To explore the analgesic effect of Anricfen after pancreaticoduodenectomy.

Secondary objective: To explore the impact of Anricfen on the accelerated recovery after pancreaticoduodenectomy.

Exploratory objective: To investigate the biomarkers of Anricfen's analgesic effect after pancreaticoduodenectomy, as well as its correlation factors with tumor pathology.

Study Overview

• Status: Recruiting
• Conditions: Patients Who Undergo Pancreaticoduodenectomy
• Intervention / Treatment: Drug: Experimental Group; Drug: Anrikefon

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: yudong QIU; Phone Number: 0086+13809021967; Email: yudongqiu510@163.com

Study Locations

• China
  • Nanjing, China
    • Recruiting
    • Nanjing Drum Tower Hospital
    • Contact: yudong QIU; Phone Number: 0086+13809021967; Email: yudongqiu510@163.com
    • Contact: Email: 1808456151@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who underwent pancreatic surgery, including pancreaticoduodenectomy (PD), pancreatic-preserving pancreaticoduodenectomy (PPPD), and laparoscopic pancreaticoduodenectomy (LPD)
• Age ≥ 18 years old and < 80 years old
• ASA Ⅰ-Ⅲ
• Be able to clearly understand and voluntarily participate in the research

Exclusion Criteria:

• Merging severe primary diseases involving the heart, brain, liver, kidneys and hematopoietic system
• History of long-term use of psychotropic drugs and cognitive dysfunction
• Having a history of acute poisoning from alcohol, sleeping pills, painkillers or other drugs that affect the central nervous system
• Pregnancy or lactation period
• History of allergy to NSAIDs, opioids, or to the test medication
• Drug users, alcoholics, and opiate abusers
• Those who had a history of chronic pain before the operation and a history of long-term use of analgesics and/or sedatives
• Those who had thyroid dysfunction before the operation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: experimental group; Postoperatively, administer Anrikefon injection intravenously at a dose of 1 μg/kg every 8 hours for three consecutive days.	Drug: Experimental Group; Postoperatively, administer Anrikefon injection intravenously at a dose of 1 μg/kg every 8 hours for three consecutive days.; Drug: Anrikefon; Postoperatively, intravenous injection of Anrikefon injection was administered at a dose of 1 μg/kg, every 8 hours, for three consecutive days as an intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of postoperative complications	After undergoing treatment for 2 months
Incidence rate of adverse events	Two month after the treatment
The VAS score within 0-72 hours after the operation	Within 3 days after receiving treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in biochemical indicators and inflammatory indicators	The unit of C-reactive protein is mg/L;The unit of WBC is ×109/L	One week after the treatment
The time of first flatus and defecation after surgery, and the time to get out of bed for activities	The time of the first postoperative standing up for activities, passing gas, and having a bowel movement is calculated in days. The postoperative hospital stay is also calculated.	One week after the treatment
Postoperative hospital stay and hospitalization costs	The postoperative hospital stay is calculated in days, and the hospitalization expenses are settled in RMB.	After undergoing treatment for 2 months
Postoperative analgesia satisfaction scores of the subjects and the satisfaction scores of the study doctors after the administration of the medication were obtained.	The postoperative pain relief satisfaction score and the doctor satisfaction score are calculated on a scale of 0 to 10, with 10 being the highest score.	Within 3 days after receiving treatment
The initial pressing time of the postoperative analgesic pump, the total number of presses, and the number of effective presses	The number of presses of the postoperative analgesic pump should be recorded based on the actual situation. Each press is counted as 1.	One day after the treatment
The time for discontinuing postoperative analgesics		After undergoing treatment for 2 months
The proportion and duration of VAS scores ≤ 3 points within 0-12 hours and 0-24 hours after the first postoperative administration		Within one day after receiving treatment
The timing and dosage of remedial analgesia		After undergoing treatment for 2 months

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: pancreaticoduodenectomy; analgesia; Peripheral κ receptor agonist; Promote recovery
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia
• Other Study ID Numbers: 2025-0770-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No