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.

Phase 2RecruitingNCT07514637

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School35 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Patients Who Undergo Pancreaticoduodenectomy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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

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

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

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

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.

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

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.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts