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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental Group, Anrikefon.
- Who it may be relevant to
- Registry conditions: Patients Who Undergo Pancreaticoduodenectomy. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Safety and Efficacy of Aniracetamfen for Postoperative Analgesia and Rehabilitation After Pancreaticoduodenectomy: A Single-center, Single-arm Clinical Study
Overview
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.
Interventions
- 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
Primary outcome measures
- The incidence of postoperative complications [Time frame: After undergoing treatment for 2 months]
- Incidence rate of adverse events [Time frame: Two month after the treatment]
- The VAS score within 0-72 hours after the operation [Time frame: Within 3 days after receiving treatment]
Secondary outcome measures (8)
- Changes in biochemical indicators and inflammatory indicators [Time frame: One week after the treatment]
- The time of first flatus and defecation after surgery, and the time to get out of bed for activities [Time frame: One week after the treatment]
- Postoperative hospital stay and hospitalization costs [Time frame: 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. [Time frame: 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 [Time frame: One day after the treatment]
- The time for discontinuing postoperative analgesics [Time frame: 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 [Time frame: Within one day after receiving treatment]
- The timing and dosage of remedial analgesia [Time frame: After undergoing treatment for 2 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
China · 1 center
- NanJing drum tower hospital — Nanjing
Identifiers
NCT: NCT07514637 · 2025-0770-01