Colorectal Cancer
Conditions
Interventions
Intervention group:Postoperative Patient-Controlled Intravenous Analgesia (PCA) using Nalbuphine
Control group:Postoperative Patient-Controlled Intravenous Analgesia (PCA) using sulfentanil
Sponsors
Ningbo No.2 Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age = 18 years, regardless of gender; 2) BMI < 30 kg/m^2; 3) Type of surgery: Primary laparoscopic radical resection of colorectal cancer (including right hemicolectomy, left hemicolectomy, sigmoidectomy, anterior resection of the rectum, etc.); 4) ASA physical status: I or II, or stable III (e.g., long-term controllable chronic diseases such as mild hypertension or diabetes); 5) Postoperative analgesia: Scheduled to use Patient-Controlled Intravenous Analgesia (PCIA); 6) Informed consent: Patients voluntarily participate in the study and sign the written informed consent form.
Exclusion criteria
Exclusion criteria: 1) Incompatible surgical method: Open surgery or palliative resection; 2) Preoperative presence of severe underlying diseases: a) Cardiac function at grade III or above; within the past 3 months, suffered from myocardial infarction or unstable angina pectoris, cerebrovascular accident or had sequelae of cerebrovascular accident; abnormal electrocardiogram and assessed by the investigator as not suitable for participating in this study; b) Significantly abnormal liver function (AST or ALT > 2*ULN or Child-Pugh B grade or above); c) Renal insufficiency: Glomerular filtration rate less than 45 ml/min/1.73m^2; d) Respiratory system diseases or history: Had severe bronchial asthma, high-risk diseases of respiratory depression (such as chronic obstructive pulmonary disease, sleep apnea syndrome, etc.), pulmonary heart disease, or severe ventilation or gas exchange dysfunction of lung function, and arterial blood gas oxygen partial pressure lower than 60 mmHg); 3) Previous history of gastrointestinal surgery and may affect gastrointestinal function (such as extensive gastrointestinal resection, post-gastrointestinal anastomosis complications, excluding appendectomy); 4) Existence of gastrointestinal functional disorders (such as preoperative chronic constipation, intestinal obstruction, intestinal paralysis); 5) Diagnosis of severe gastrointestinal diseases (such as inflammatory bowel disease, functional dyspepsia); 6) Had acute or chronic painful physical diseases at other non-surgical sites and the investigator assessed that they may affect postoperative pain assessment; 7) Had radiotherapy or neoadjuvant chemoradiotherapy before surgery and had not fully recovered (less than 4 weeks); 8) Had taken monoamine oxidase inhibitors (MAOIs) before surgery or stopped MAOIs within 14 days (including anti-depressant MAOIs: phenelzine, imipramine, bupropion, haloperidol, etc.; MAO-B inhibitors for treating Parkinson's disease: selegiline, rasagiline, etc.; others: linezolid); 9) Allergic to nalbuphine or other opioid drugs; 10) Had used the following drugs continuously or cumulatively for more than 10 days within 1 month before surgery: opioid analgesics; sedative/hypnotic drugs or anti-anxiety drugs; glucocorticoids (systemic use); other immunosuppressants; 11) Have a history of using other drugs that can significantly affect postoperative gastrointestinal function (such as anticholinergic drugs, pro-gastrointestinal motility drugs); 12) Pregnant or lactating women; 13) Complicated with mental disorders, cognitive dysfunction or poor compliance; 14) The patient is simultaneously participating in other ongoing interventional clinical studies; 15) There are other situations that the researcher considers not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recovery time of gastrointestinal function; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to GI-3;Incidence of postoperative ileus;Visual Analog Scale;Incidence of adverse reactions;Incidence of postoperative delirium;Postoperative Quality of Recovery-15 (QoR-15) score;Total length of hospital stay ;30-day readmission rate;30-day mortality rate;90-day mortality rate;Incidence of major postoperative complications within 30 days ; | — |
Countries
China
Contacts
Public ContactLi Xiaoyu
Ningbo No.2 Hospital
Outcome results
None listed