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Opioid - Sparing Strategy Based on Epidural Hydromorphone Promotes the Recovery of Gastrointestinal Function after Abdominal Surgery: A Prospective, Randomized Controlled, Open - Label Study

Opioid - Sparing Strategy Based on Epidural Hydromorphone Promotes the Recovery of Gastrointestinal Function after Abdominal Surgery: A Prospective, Randomized Controlled, Open - Label Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600132170
Enrollment
Unknown
Registered
2026-09-10
Start date
2026-09-10
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Post-abdominal surgery, gastrointestinal dysfunction may occur, with clinical manifestations including postoperative ileus (POI), abdominal distension, nausea and vomiting, delayed flatus and defecation, and food intolerance leading to delayed oral feeding.

Interventions

Experimental group:Epidural infusion of hydromorphone

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 years and 80 years; 2. BMI ranging from 18.0 to 28.0; 3. Planned for abdominal gastrointestinal surgery (including laparoscopic or open surgery, excluding liver or pancreaticoduodenectomy, etc.), with an estimated operation time of >= 2 hours; 4. ASA classification of grades I to III; 5. Agree to use general anesthesia combined with epidural anesthesia; 6. No history of chronic pain or abuse of opioid drugs before the operation; 7. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Severe underlying heart and lung diseases; 2) Previous central nervous system diseases, spinal deformities or injuries, history of spinal surgery, or abnormal coagulation function and other contraindications for epidural puncture; 3) Cognitive dysfunction, unable to cooperate with the study; 4) Uncontrolled mental system diseases or concurrent severe neuromuscular diseases (such as myasthenia gravis); 5) Allergy to opioids and any drugs involved in the study; 6) Preoperative severe gastrointestinal dysfunction diseases, such as: chronic intestinal obstruction, inflammatory bowel disease (Crohn's disease, ulcerative colitis), advanced liver cirrhosis with intractable ascites, or a history of major gastrointestinal surgery; 7) Long-term use of drugs that seriously affect gastrointestinal motility before surgery (such as: long-term use of laxatives, anticholinergic drugs, GLP-1 receptor agonists, etc.); 8) Severe liver and kidney dysfunction (Child-Pugh C grade or eGFR < 30 ml/min/1.73m^2).9)Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
rate of return of gut function at 72 hours after surgery measured by GI-3 recovery;

Secondary

MeasureTime frame
I-FEED Score;Total perioperative opioid consumption (up to 72 hours);time to GI-3 recovery;Time to GI-2 recovery;Incidence of Perioperative Complications;Quality of Recovery–15 score;

Countries

China

Contacts

Public ContactXu Pingbo

Zhejiang Cancer Hospital

xupingboshanghai@163.com+86 571 8812 2105

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 19, 2026