None
Conditions
Interventions
Group 1:First time: SimpLi-PIN - Disposable needle
Second time: Disposable needle - SimpLi-PIN
Third time: SimpLi-PIN - Disposable needle
Fourth time: Disposable Needle - SimpLi-PIN
Group 2:First time: Disposable needle - SimpLi-PIN
Second time: SimpLi-PIN - Disposable needle
Third time: Disposable needle - SimpLi-PIN
Fourth time: SimpLi-PIN - Disposable needle.
Sponsors
Obstetrics and Gynecology Hospital of Fudan University
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Age = 18 years; (2) Singleton pregnancy; (3) Elective cesarean section under CSEA; (4) According to GCP regulations, being able to understand and sign written informed consent, and voluntarily participating in the trial.
Exclusion criteria
Exclusion criteria: (1) Preoperative BMI < 23 kg/m²; (2) Gestational age < 37 weeks; (3) Estimated fetal birth weight < 2500 g; (4) Contraindications to neuraxial anesthesia; (5) Skin abnormalities at the assessment site (e.g., damage, tattoos, skin disease); (6) Neurological disorders affecting pain sensitivity; (7) Hearing or communication impairments; (8) Refusal to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kappa consistency between SimpLi-PIN and traditional pinprick in assessing sensory block level; | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of skin damage at the measurement site;Pain intensity score;Degree of motor blockade; | — |
Countries
China
Contacts
Public ContactJingjing Liu
Obstetrics and Gynecology Hospital of Fudan University
Outcome results
None listed