Effects of nalmefene on postoperative analgesia, a multicenter, prospective, randomized, double-blinded controlled trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000032472

Enrollment

Unknown

Registered

2020-04-29

Start date

2020-05-01

Completion date

Unknown

Last updated

2020-05-04

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

Conditions

Observation on postoperative analgesia of single upper limb fracture/ lower extremity fracture / clavicle fracture

Interventions

Dezocine C group:placebo

dezocine N group:nalmefene

fentanyl C group:placebo

fentanyl N group:nalmefene

sufentanil C group :placebo

sufentanil N group :nalmefene

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with single upper limb / lower limb / clavicle fracture after general anesthesia; 2. Patients with single and single fracture, excluding comminuted fracture, and having little difficulty in preoperative evaluation; 3. Gender is not limited, ASA grade I-II, aged 20-70 years, body mass index (BMI) 20-29kg / ?; 4. The patients who have no basic diseases of cardiopulmonary system and no history of disease attack, such as bronchospasm, asthma, etc.; 5. Patients with normal intelligence, ability to understand and willing to participate in this study, and willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women; 2. Patients with a long history of painful diseases; 3. Patients with allergic history of opioids or their antagonists; 4. Patients with a history of drug or alcohol dependence; 5. Patients with severe cardiopulmonary function, liver and kidney dysfunction; 6. Patients with severe snoring and obesity (BMI > 30 kg / m2); 7. Patients with history of digestive system diseases; 8. Patients with high blood pressure, diabetes, mental disorders and mental disorders.

Design outcomes

Primary

Measure	Time frame
Visual Analogue Scale/Score;Preoperative condition;Vital signs;Outcome of side effects of analgesics;Ramsay Sedation score;OAA/S sedation rating standard;application of self-control analgesia pump;Sleep quality of patients;Forecast model parameters;	—

Secondary

Measure	Time frame
Basic information of patients;Intraoperative condition;	—

Countries

China

Contacts

Public ContactDekun Yin

Funing People's Hospital of Jiangsu Province

kundymedical@qq.com+86 15805110243

Outcome results

None listed

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