Acute Postoperative Pain in Patients Undergoing Minimally Invasive Distal Pancreatectomy
Conditions
Interventions
Sufentanil PCIA group:Sufentanil 100 µ g each time
Anrikefon PCIA group:Anrikefon 1mg per dose
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 80 years; 2. American Society of Anesthesiologists (ASA) classification I-III; 3. BMI between 18 kg/m^2 and 30 kg/m^2; 4. Patients scheduled for elective minimally invasive (laparoscopic or robotic) distal pancreatectomy under general anesthesia; 5. Expected surgery duration less than 5 hours; 6. Agree to participate in this trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Emergency surgery or trauma patients; 2.Unwilling to use patient-controlled intravenous analgesia (PCIA); 3.History of abdominal surgery within the past 3 months; 4.Tumor patients receiving neoadjuvant therapy before surgery; 5.Expected requirement for continued endotracheal intubation postoperatively; 6.History or evidence of any of the following diseases prior to screening: Severe cardiopulmonary disease (myocardial infarction, heart failure, or respiratory failure) Neurological or psychiatric history: craniocerebral injury, intracranial hypertension, schizophrenia, mania, etc., assessed by the investigator as unsuitable for study participation History of digestive system disease: patients with a history of intestinal obstruction Severe renal dysfunction (estimated glomerular filtration rate < 30 mL/min/1.73m^2); 7.Severe renal dysfunction (estimated glomerular filtration rate < 30ml/min/1.73m^2); 8.Continuous use of opioid analgesics for more than 10 days for any reason or a history of alcohol abuse within 3 months prior to screening; 9.Opioid and non-opioid analgesics were used in advance before the operation, and the interval between the last administration and randomization was shorter than five half-lives of the drug or the duration of the response. 10.Known to be allergic to or contraindicated to opioid drugs and other anesthetics, antiemetic drugs, NSAIDs, etc. that may be used during the trial; 11.Situations where other researchers or attending physicians consider it inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The area under the curve (AUC0-72h) of the NRS score at rest from 0 to 72 hours after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of nausea, vomiting, and PONV within 24h, 48h, and 72h postoperatively;Quality of Recovery (QoR) of patients at 48 h and 72 h postoperatively, evaluated using the QoR-15 scale.;Postoperative resting NRS AUC0-24h, AUC0-48h;Postoperative Activity (Deep Breathing/Coughing) NRS AUC????h, AUC????h, AUC????h (surgical pain induced when the patient takes 3 deep breaths or coughs; record the highest pain score value);The time (h) from the recovery of intestinal function (first defecation/exhaust) to the end of the surgery;The resting and activity NRS pain scores were assessed at 1h+/-30min, 4h+/-1h, 8h+/-2h, 16h+/-2h, 24h+/-2h, 36h+/-2h, 48h+/-2h, and 72h+/-2h postoperatively;The proportion of patients with resting and activity NRS scores >= 3 during postoperative 0h–24h, 0h–48h, and 0h–72h.;Inflammatory factor levels at 72 hours postoperatively and their changes compared to preoperative levels (TNF-a, CRP, IL-6, IL-8) (record the inflammatory factor levels from the patient's routine tests without adding additional tests);Total number of PCIA demands and effective deliveries within 0–24 h, 0–48 h, and 0–72 h postoperatively.;Proportion of rescue analgesia use and cumulative dosage of rescue analgesics within 0–24 h, 0–48 h, and 0–72 h postoperatively.;Patient satisfaction score at 72 hours postoperatively;Incidence of rescue antiemetic therapy and cumulative dosage of rescue antiemetics within 0–24 h, 0–48 h, and 0–72 h postoperatively;Overall Benefit Analgesia Score (OBAS) at 24 h, 48 h, and 72 h postoperatively;Time from end of surgery to first ambulation (hours)Time from end of surgery to recovery of bowel function (first defecation / flatus) (hours);Incidence of various complications during hospitalization (pancreatic fistula, surgical site infection, postoperative pancreatitis) and the severity of complications.; | — |
Countries
China
Contacts
Public ContactYan Luo
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed