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Study for the efficacy and safety of disposable continuous peripheral nerve block set in postoperative analgesia of upper and lower limbs — a multi-center, single-blind, randomized, positive, parallel controlled clinical trial

Study for the efficacy and safety of disposable continuous peripheral nerve block set in postoperative analgesia of upper and lower limbs — a multi-center, single-blind, randomized, positive, parallel controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022980
Enrollment
Unknown
Registered
2019-05-06
Start date
2019-05-15
Completion date
Unknown
Last updated
2019-05-13

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

Conditions

pain

Interventions

experimental group:Disposable continuous peripheral nerve block set
control group: Continuous peripheral nerve block catheter set of German Braun company

Sponsors

Tongji Hospital of Shanghai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: ? Male and female aged 18-70 years; ? Patients who received upper and lower limb surgery(including clavicular fracture, humerus fracture, ankle fractures and calcaneal fractures) and expected postoperative analgesia time 24h; ? 18Kg/m2=BMI=28Kg/m2; ? Patients graded I, II, III level of American Society of anesthesiologists (American Socitey of Anesthesiology, ASA) grading standard; ? Patients who know the procedure and operate PCA equipment well, and communicate with researchers well; ? Patients agree to participate in the test, and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with liver function obviously abnormal, ALT and/or AST>2×ULNor TBIL=1.5×ULN; 2. Patients with renal function obviously abnormal; Scr>112µmol/L; 3. Patients with high risk of blood; 4. The electrocardiogram were significantly abnormal; 5. Hypertension patients with unsatisfactory control of blood pressure; 6. Diabetic patients with unsatisfactory blood glucose control (Fasting plasma glucose=11mmol/L); 7. Patients with skin infection of anesthesia puncture site or severe systemic infection; 8. Patients participating in other clinical trials within 30 days; 9. Patients with peripheral neuropathy or other nerve block contraindication; 10. Patients with tumor; 11. The female patients who are pregnant or lactating (confirmed by HCG test); 12. Patients who researchers think them should not participate in the clinical trial.

Design outcomes

Primary

MeasureTime frame
The analgesic effectIve rate during 24h postoperation;—

Secondary

MeasureTime frame
The satisfaction of patients;The satisfaction of doctors;The effective rate of analgesic pump presses;Immediate analgesic effect 24h postoperative;—

Countries

China

Contacts

Public ContactBin Yu

Tongji Hospital of Shanghai

yubin@tongji.edu.cn+86 13918108880

Outcome results

None listed

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