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.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Experimental Group

    Drug

    Postoperatively, administer Anrikefon injection intravenously at a dose of 1 μg/kg every 8 hours for three consecutive days.

  • Anrikefon

    Drug

    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

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: experimental groupOther 2 interventions

Trial outcomes

Primary outcomes

1

The incidence of postoperative complications

Time frame
After undergoing treatment for 2 months
2

Incidence rate of adverse events

Time frame
Two month after the treatment
3

The VAS score within 0-72 hours after the operation

Time frame
Within 3 days after receiving treatment

Secondary outcomes

1

Changes in biochemical indicators and inflammatory indicators

The unit of C-reactive protein is mg/L;The unit of WBC is ×109/L

Time frame
One week after the treatment
2

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.

Time frame
One week after the treatment
3

Postoperative hospital stay and hospitalization costs

The postoperative hospital stay is calculated in days, and the hospitalization expenses are settled in RMB.

Time frame
After undergoing treatment for 2 months
4

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.

Time frame
Within 3 days after receiving treatment

Other outcomes

Sponsors and contacts

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