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A randomized controlled trial for nalbuphine combined with sufentanil PCIA for postoperative analgesia in patients undergoing open surgery

A randomized controlled trial for nalbuphine combined with sufentanil PCIA for postoperative analgesia in patients undergoing open surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020059
Enrollment
Unknown
Registered
2018-12-12
Start date
2018-12-24
Completion date
Unknown
Last updated
2018-12-18

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

Conditions

Postoperative pain in patients undergoing open surgery

Interventions

Group 1:Sufentanil 2µg/ml PCIA
Group 2:Nabuphine 1mg/ml + sufentanil 1µg/ml PCIA

Sponsors

Xijing Hospital Fourth Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Open surgery patients; 2. ASA I-II; 3. aged between 18 and 65 years old; 4. BMI between 19 and 29 kg/m2.

Exclusion criteria

Exclusion criteria: 1. Poor compliance, can not cooperate with the surgery; 2. Severe organic disease (coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, abnormal electrolytes); 3. II degree and above atrioventricular block, bradycardia (HR <50 beats / min), hypotension (SBP <90mmHg); 4. History of neurological diseases; history of chronic pain; drug addiction and alcoholism; long-term application of opioids; 5. Patients who are allergic to nalbuphine hydrochloride or components thereof, and patients with allergic history of opioids; 6. Gastric emptying restriction and stomach cramps; 7. Patients with weakened bowel movements or intestinal obstruction; 8. Clinical trial participants who have participated in other drugs in the past 4 weeks; 9. With other circumstances, the investigator believes that it is not suitable for the selected patients.

Design outcomes

Primary

MeasureTime frame
NRS resting and active pain scores;

Secondary

MeasureTime frame
Function score;Total PCA times and PCA effective times;LOS sedation score;Changes in blood pressure, heart rate, respiration, and pulse oxygen;Pain satisfaction;Incidence of adverse reactions;

Countries

China

Contacts

Public ContactDong Hailong

First Affiliated Hospital of Fourth Military Medical University

345169823@qq.com+86 029-84775337

Outcome results

None listed

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