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Effect and Genetic Dimorphism of Namefene in the Prevention of Pruritus Induced by Epidural Opioids

Effect and Genetic Dimorphism of Namefene in the Prevention of Pruritus Induced by Epidural Opioids

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050463
Enrollment
Unknown
Registered
2021-08-27
Start date
2021-09-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Pruritus

Interventions

Experimental group:Preventive giving of 0.5ug/kg of namefene postoperatively
Control group:Normal saline

Sponsors

Fudan University Zhongshan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Voluntary participation, the patient himself understands and signs the informed consent form; 2. Aged 18-80 years; 3. Patients who undergo surgery and voluntarily undergo epidural and postoperative analgesia; 4. In line with epidural analgesia indications: normal coagulation function; platelets >=75x10^9/L.

Exclusion criteria

Exclusion criteria: 1. Systemic infection state or the presence of foci of infection at the puncture site; Improper discontinuation of anticoagulant and antiplatelet agents; circulatory erratics; Those who suffer from mental illness and cannot cooperate; People with limb autonomy impairment; 2. The success of the epidural operation is uncertain due to trauma, deformity, implants, low back pain, etc. at the puncture site; 3. Those with serious abnormalities in the function of important organs before surgery; 4. Patients who cannot understand and cannot safely use an epidural analgesia pump; 5. Lack of expression and comprehension ability, unable to communicate effectively, do not understand the degree of itching and analgesia scorer; 6. Patients with a history of allergy to nalmefen injection before surgery; 7. Previous itching symptoms: patients with skin history, gout history, rheumatic immune diseases; 8. Those who are allergic to antibiotics, anesthetics or latex during the perioperative period; 9. Patients who have received allogeneic blood transfusion in the past 1 month; 10. Patients with serious complications in the perioperative period.

Design outcomes

Primary

MeasureTime frame
the incidence of pruritus 24h after the surgery;

Secondary

MeasureTime frame
the first reported time point of pruritus;The patient's postoperative sleep quality;other anesthesia/analgesia related side effects;the severity of the acute pain postoperatively;the severity of pruritus postoperatively;

Countries

China

Contacts

Public ContactFang Fang

Fudan University Zhongshan Hospital

Fang.fang@zs-hospital.sh.cn+86 13681972715

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026