NCT00980577

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Last Updated

November 10, 2010

Status Verified

September 1, 2009

Enrollment Period

1.8 years

First QC Date

September 18, 2009

Last Update Submit

November 9, 2010

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • time and number of attempts to perform block, the efficacy of the block

    during the block procedure

Secondary Outcomes (1)

  • postoperative analgesic effect

    pod 1-3

Study Arms (1)

NS

ACTIVE COMPARATOR

stimulating catheter will be inserted using stimulator

Device: NUUS

Interventions

NUUSDEVICE

Sonosite Micro Maxx

Also known as: stimulating catheter will be inserted under stimulator and ungrasoud guidance
NS

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hosptial

Beijing, 100191, China

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Min Li, MD

CONTACT

86-10-82266688liminanesth@yahoo.com.cn

Xuedong Wang, MS

CONTACT

86-10-82266688wangxuedong1216@sina.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 18, 2009

First Posted

September 21, 2009

Study Start

January 1, 2008

Primary Completion

November 1, 2009

Last Updated

November 10, 2010

Record last verified: 2009-09

Locations

CN(1)