NCT00653133

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,821

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started May 2007

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

16 active sites

Status
completed

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

May 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

August 19, 2013

Completed
Last Updated

October 2, 2018

Status Verified

December 1, 2014

Enrollment Period

1.8 years

First QC Date

March 28, 2008

Results QC Date

May 19, 2011

Last Update Submit

September 1, 2018

Conditions

Postoperative Pain

Keywords

ultrasonographyperipheral nerve blockperipheral nerve stimulation

Outcome Measures

Primary Outcomes (1)

  • Complications of Peripheral Nerve Block

    Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic

    Preoperative through 3 days post operative

Study Arms (2)

USPNB

ACTIVE COMPARATOR

Ultrasound imaging guided peripheral nerve block

Device: Ultrasound imaging

NSPNB

ACTIVE COMPARATOR

Peripheral nerve stimulator guided peripheral nerve block catheter placement for continuous infusion of local anesthetic

Device: Peripheral nerve stimulator

Interventions

Ultrasound imagingDEVICE

Ultrasound guided techniques for placement of peripheral nerve block catheters for continuous infusion of local anesthetic

USPNB
Peripheral nerve stimulatorDEVICE

either stimulating needle or stimulating catheter used for placement of catheter for continuous infusion of local anesthetic

NSPNB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Arizona Joint and Spine

Chandler, Arizona, 85224, United States

Location

Santa Clara Valley Medical Center

San Jose, California, 4088855230, United States

Location

Avista Adventist Hospital

Louisville, Colorado, 80027, United States

Location

Kennestone Hospital

Atlanta, Georgia, 30060, United States

Location

The Medical Center of Bowling Green

Bowling Green, Kentucky, 42101, United States

Location

Caritas Good Samaritan

Stoughton, Massachusetts, 02072, United States

Location

Wesley Medical Center

Hattiesburg, Mississippi, 39402, United States

Location

DesPeres Hospital

St Louis, Missouri, 63131, United States

Location

St. Vincents Catholic Medical Center

New York, New York, 10011, United States

Location

Charlotte Medical Center

Charlotte, North Carolina, 28203, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45459, United States

Location

Bailey Medical Center

Owasso, Oklahoma, 74055, United States

Location

Roper Hospital

Charleston, South Carolina, 29403, United States

Location

Memorial Herman Hospital

Houston, Texas, 77030, United States

Location

Titus Regional Medical Center

Mount Pleasant, Texas, 75455, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 25298, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Alan Dine Director of Clinical Research
Organization
I-Flow Corporation
alan.dine@kcc.com
513-253-8033

Study Officials

  • Joe Rodrigo, MD

    Roper Hospital, Charleston, SC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2008

First Posted

April 4, 2008

Study Start

May 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

October 2, 2018

Results First Posted

August 19, 2013

Record last verified: 2014-12

Locations

US(16)