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Multicenter Continuous Peripheral Nerve Block Surveillance Study (cpnb)

H

Halyard Health

Status

Completed

Conditions

Postoperative Pain

Treatments

Device: Ultrasound imaging
Device: Peripheral nerve stimulator

Study type

Interventional

Funder types

Industry

Identifiers

NCT00653133
iflocpnb2007

Details and patient eligibility

About

This two tiered study is a multi-center, open label, surveillance study of the use of continuous nerve blocks with the ON-Q® C-bloc and either nerve stimulator or ultrasound guided continuous nerve block techniques. This study was developed to investigate specific aspects of complication rates related to continuous nerve block techniques in patients undergoing orthopedic surgical procedures.

Full description

Continuous peripheral nerve block techniques require the placement of catheters near target peripheral nerves. The placement of these catheters is guided by either ultrasound visualization, nerve stimulation or a combination of the two.

This surveillance study was designed to look at the rates of catheter placement related complications with the two techniques.

Enrollment

1,821 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients having elective orthopedic surgery who are candidates for CPNB as part of their management program for postoperative pain
  • Age >18
  • Able to give consent

Exclusion criteria

  • Morbid obesity (BMI> 40)
  • Uncooperative or having psychological or linguistic difficulties
  • Previous damage to the nerve or plexus
  • Significant comorbidities which the primary investigator feels would limit the quality and collection of data
  • Allergy to local anesthetic agents including ropivacaine, bupivacaine and lidocaine

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,821 participants in 2 patient groups

USPNB
Active Comparator group
Description:
Ultrasound imaging guided peripheral nerve block
Treatment:
Device: Ultrasound imaging
NSPNB
Active Comparator group
Description:
Peripheral nerve stimulator guided peripheral nerve block catheter placement for continuous infusion of local anesthetic
Treatment:
Device: Peripheral nerve stimulator

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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