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Effect of hydromorphone combined with nalbuphine on postoperative analgesia in patients undergoing laparoscopic surgery

Effect of hydromorphone combined with nalbuphine on postoperative analgesia in patients undergoing laparoscopic surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071471
Enrollment
Unknown
Registered
2023-05-16
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Analgesia after general anesthesia

Interventions

HN group:Hydromorphone 0.7ug/kg/ml+narbuphine7ug/kg/ml
H group:Hydromorphone 1.4 ug/kg/ml

Sponsors

Shengjing Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. ASA Grade I or II 2. Age 18-65, BMI 18-35 kg/m2 3. Laparoscopic abdominal surgery (hepatobiliary surgery, gastroduodenectomy, splenectomy, pancreatectomy, nephrectomy, colorectal resection)

Exclusion criteria

Exclusion criteria: 1. Merge pain related diseases unrelated to surgery, such as herpes zoster, trigeminal neuralgia, etc 2. Individuals with a previous history of opioid allergy and allergies to hydromorphone, hydromorphone salts, and nabrphine; Drug abusers; 3. Previous history of nausea and vomiting after general anesthesia and abnormal anesthesia recovery; 4. Preoperative liver and kidney function abnormalities (alanine transaminase, glutamic oxaloacetic transaminase, creatinine, urea nitrogen more than twice the normal value); 5. Those who are unable to communicate normally with others, cannot understand NRS scores, and cannot use pain pumps; 6. Use sedatives, antiemetics, and antipruritic drugs within 24 hours before surgery; 7. Long term use of analgesics or antipsychotics (including opioids, non steroidal anti-inflammatory drugs, sedatives, antidepressants, etc.) due to chronic pain or mental or nervous system disease 8. Patients with severe or acute asthma; 9. Change in surgical method and transfer to intensive care unit (ICU) after surgery; 10. There is a risk of gastrointestinal obstruction, especially in patients with paralytic intestinal obstruction. Patients with fertility requirements within one year.

Design outcomes

Primary

MeasureTime frame
NRS pain score at each time point immediately after operation, entering the recovery room, 2h, 6h, 12h, 24h and 48h after operation;The overall benefit of analgesia scores at the time points immediately after operation, entering the recovery room, 2h, 6h, 12h, 24h and 48h after operation is OBAS.;Cognitive function evaluation and MMSE score of patients 1 and 2days after operation;

Secondary

MeasureTime frame
Number of analgesic pump compressions;Total drug consumption and total self-administered analgesic medication;Intraoperative blood loss and fluid administration;Whether lung infection;

Countries

China

Contacts

Public ContactYang Fan

Shengjing Hospital of China Medical University

yfysjx@126.com+86 189 4025 6891

Outcome results

None listed

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