Stimulating Catheter With or Without Ultrasound Guidance

Pain Clinical Trial

Official title:

Phase 2 Study of Stimulating Catheter for Continuous Femoral Nerve Block in Total Knee Replacement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00980577
• Other study ID #: PUTH7275
• Status: Recruiting
• Phase: Phase 4
• First received: September 18, 2009
• Last updated: November 9, 2010
• Start date: January 2008

Study information

• Verified date: September 2009
• Source: Peking University Third Hospital
• Contact: Min Li, MD
• Phone: 86-10-82266688
• Email: liminanesth[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To study whether the combination of ultrasound guidance and stimulating catheter could reduce the time for needle and catheter insertion compared with using stimulating catheter alone. Secondary outcomes: analgesic effects after the surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

Inclusion Criteria:

• Elective primary total knee replacement surgery under neuraxial anesthesia ASA<=4

• Able to give informed consent

• Able to cooperate with sensory and motor testing of lower limb function

Exclusion Criteria:

• coagulopathy

• Allergy to local anaesthetic or postanalgesic rescue regimen

• Signs, symptoms or laboratory evidence of local infection or systemic sepsis

• No pre-existing neurological deficit (sensory or motor) affecting lower limb

• Patients with lower limb amputations

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• NUUS
Sonosite Micro Maxx

Locations

Country	Name	City	State
China	Peking University Third Hosptial	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time and number of attempts to perform block, the efficacy of the block		during the block procedure	Yes
Secondary	postoperative analgesic effect		pod 1-3	Yes