Patients Who Undergo Pancreaticoduodenectomy
Conditions
Keywords
pancreaticoduodenectomy, Peripheral κ receptor agonist, analgesia, Promote recovery
Brief summary
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
DRUGExperimental Group
Postoperatively, administer Anrikefon injection intravenously at a dose of 1 μg/kg every 8 hours for three consecutive days.
DRUGAnrikefon
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
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in biochemical indicators and inflammatory indicators | One week after the treatment | The unit of C-reactive protein is mg/L;The unit of WBC is ×109/L |
| The time of first flatus and defecation after surgery, and the time to get out of bed for activities | One week after the treatment | 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. |
| Postoperative hospital stay and hospitalization costs | After undergoing treatment for 2 months | The postoperative hospital stay is calculated in days, and the hospitalization expenses are settled in RMB. |
| Postoperative analgesia satisfaction scores of the subjects and the satisfaction scores of the study doctors after the administration of the medication were obtained. | Within 3 days after receiving treatment | 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. |
| The initial pressing time of the postoperative analgesic pump, the total number of presses, and the number of effective presses | One day after the treatment | The number of presses of the postoperative analgesic pump should be recorded based on the actual situation. Each press is counted as 1. |
| 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 | — |
Countries
China
Contacts
CONTACTyudong QIU
Outcome results
None listed