Multicenter Continuous Peripheral Nerve Block Surveillance Study (cpnb)
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound imaging
Peripheral nerve stimulator
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring ultrasonography, peripheral nerve block, peripheral nerve stimulation
Eligibility Criteria
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
Sites / Locations
- Arizona Joint and Spine
- Santa Clara Valley Medical Center
- Avista Adventist Hospital
- Kennestone Hospital
- The Medical Center of Bowling Green
- Caritas Good Samaritan
- Wesley Medical Center
- DesPeres Hospital
- St. Vincents Catholic Medical Center
- Charlotte Medical Center
- Miami Valley Hospital
- Bailey Medical Center
- Roper Hospital
- Memorial Herman Hospital
- Titus Regional Medical Center
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
USPNB
NSPNB
Arm Description
Ultrasound imaging guided peripheral nerve block
Peripheral nerve stimulator guided peripheral nerve block catheter placement for continuous infusion of local anesthetic
Outcomes
Primary Outcome Measures
Complications of Peripheral Nerve Block
Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00653133
Brief Title
Multicenter Continuous Peripheral Nerve Block Surveillance Study
Acronym
cpnb
Official Title
Multicenter Continuous Peripheral Nerve Block Surveillance Study Comparing Ultrasound Guided Catheter Placement to Non Ultrasound Guided Catheter Placement Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Halyard Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
ultrasonography, peripheral nerve block, peripheral nerve stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1821 (Actual)
8. Arms, Groups, and Interventions
Arm Title
USPNB
Arm Type
Active Comparator
Arm Description
Ultrasound imaging guided peripheral nerve block
Arm Title
NSPNB
Arm Type
Active Comparator
Arm Description
Peripheral nerve stimulator guided peripheral nerve block catheter placement for continuous infusion of local anesthetic
Intervention Type
Device
Intervention Name(s)
Ultrasound imaging
Intervention Description
Ultrasound guided techniques for placement of peripheral nerve block catheters for continuous infusion of local anesthetic
Intervention Type
Device
Intervention Name(s)
Peripheral nerve stimulator
Intervention Description
either stimulating needle or stimulating catheter used for placement of catheter for continuous infusion of local anesthetic
Primary Outcome Measure Information:
Title
Complications of Peripheral Nerve Block
Description
Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic
Time Frame
Preoperative through 3 days post operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joe Rodrigo, MD
Organizational Affiliation
Roper Hospital, Charleston, SC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Joint and Spine
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Santa Clara Valley Medical Center
City
San Jose
State/Province
California
ZIP/Postal Code
4088855230
Country
United States
Facility Name
Avista Adventist Hospital
City
Louisville
State/Province
Colorado
ZIP/Postal Code
80027
Country
United States
Facility Name
Kennestone Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
The Medical Center of Bowling Green
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Caritas Good Samaritan
City
Stoughton
State/Province
Massachusetts
ZIP/Postal Code
02072
Country
United States
Facility Name
Wesley Medical Center
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39402
Country
United States
Facility Name
DesPeres Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
St. Vincents Catholic Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Charlotte Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Bailey Medical Center
City
Owasso
State/Province
Oklahoma
ZIP/Postal Code
74055
Country
United States
Facility Name
Roper Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Memorial Herman Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Titus Regional Medical Center
City
Mount Pleasant
State/Province
Texas
ZIP/Postal Code
75455
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
25298
Country
United States
12. IPD Sharing Statement
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Multicenter Continuous Peripheral Nerve Block Surveillance Study
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