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Effect of patient-controlled intravenous analgesia with nalbuphine combined with sufentanil on gastrointestinal function recovery after laparoscopic colorectal surgery A single-center, prospective, randomized controlled study was conducted

Effect of patient-controlled intravenous analgesia with nalbuphine combined with sufentanil on gastrointestinal function recovery after laparoscopic colorectal surgery A single-center, prospective, randomized controlled study was conducted

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096771
Enrollment
Unknown
Registered
2025-02-06
Start date
2025-02-20
Completion date
Unknown
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal disease

Interventions

Experimental Group:Nalbuphine 0.4mg/kg was added to the postoperative patient-controlled intravenous analgesia pump
Control Group:Nalbuphine injection was not added to the postoperative patient-controlled intravenous analgesia pump

Sponsors

Chengdu Seventh People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) aged 18-75 years old; 2) patients undergoing elective laparoscopic colorectal surgery; 3) ASA grade I-III;

Exclusion criteria

Exclusion criteria: 1) patients with previous gastrointestinal surgery; 2) patients who were converted to open surgery; 3)BMI > 30 kg/m^2; 4) patients with a history of radiotherapy/chemotherapy within 14 days before surgery; 5) patients who received gastrointestinal prokinetic drugs within 24 hours before surgery; 6) severe liver and kidney dysfunction (severe liver dysfunction refers to alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 2 times the upper limit of normal; Severe renal insufficiency defined as glomerular filtration rate (GFR) < 30 mL/min); 7) pregnant/lactating patients; 8) allergy to study drug or opioid dependence; 9) participants who were enrolled in other interventional clinical trials within 3 months before dosing and/or planned to participate in the trial during the study period;

Design outcomes

Primary

MeasureTime frame
Incidence of gastrointestinal dysfunction within 72 hours after surgery (defined as I-FEED score >=6);

Secondary

MeasureTime frame
I-FEED score at 24h, 48h, and 72h after surgery;Time to first flatus after operation (h);First postoperative defecation time (h);Time to first oral feeding after surgery (h);NRS scores at 24h, 48h and 72h after operation, the number of patient-controlled infusion and the number of rescue analgesia were recorded;RASS sedation score at 24h, 48h and 72h after surgery;Occurrence of adverse drug reactions;Postoperative hospital stay (d);

Countries

China

Contacts

Public ContactHui Zhong

Chengdu Seventh People's Hospital

863075252@qq.com+86 182 8031 8565

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026