cpnb: Multicenter Continuous Peripheral Nerve Block Surveillance Study

• Sponsor: Halyard Health (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00653133
• Collaborator: (none)
• Enrollment: 1,821
• Locations: 16
• Arms: 2
• Duration (Months): 22
• Patients Per Site: 113.8
• Patients Per Site Per Month: 5.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Device: Ultrasound imaging; Device: Peripheral nerve stimulator	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1821 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multicenter Continuous Peripheral Nerve Block Surveillance Study Comparing Ultrasound Guided Catheter Placement to Non Ultrasound Guided Catheter Placement Techniques
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: USPNB Ultrasound imaging guided peripheral nerve block	Device: Ultrasound imaging; Ultrasound guided techniques for placement of peripheral nerve block catheters for continuous infusion of local anesthetic
Active Comparator: NSPNB Peripheral nerve stimulator guided peripheral nerve block catheter placement for continuous infusion of local anesthetic	Device: Peripheral nerve stimulator; either stimulating needle or stimulating catheter used for placement of catheter for continuous infusion of local anesthetic

Outcome Measures

Primary Outcome Measures

1. Complications of Peripheral Nerve Block [Preoperative through 3 days post operative]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Joint and Spine	Chandler	Arizona	United States	85224
2	Santa Clara Valley Medical Center	San Jose	California	United States	4088855230
3	Avista Adventist Hospital	Louisville	Colorado	United States	80027
4	Kennestone Hospital	Atlanta	Georgia	United States	30060
5	The Medical Center of Bowling Green	Bowling Green	Kentucky	United States	42101
6	Caritas Good Samaritan	Stoughton	Massachusetts	United States	02072
7	Wesley Medical Center	Hattiesburg	Mississippi	United States	39402
8	DesPeres Hospital	Saint Louis	Missouri	United States	63131
9	St. Vincents Catholic Medical Center	New York	New York	United States	10011
10	Charlotte Medical Center	Charlotte	North Carolina	United States	28203
11	Miami Valley Hospital	Dayton	Ohio	United States	45459
12	Bailey Medical Center	Owasso	Oklahoma	United States	74055
13	Roper Hospital	Charleston	South Carolina	United States	29403
14	Memorial Herman Hospital	Houston	Texas	United States	77030
15	Titus Regional Medical Center	Mount Pleasant	Texas	United States	75455
16	Virginia Commonwealth University	Richmond	Virginia	United States	25298

Sponsors and Collaborators

• Halyard Health

Investigators

• Principal Investigator: Joe Rodrigo, MD, Roper Hospital, Charleston, SC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Halyard Health
• ClinicalTrials.gov Identifier: NCT00653133
• Other Study ID Numbers: iflocpnb2007
• First Posted: Apr 4, 2008
• Last Update Posted: Oct 2, 2018
• Last Verified: Dec 1, 2014

• Keywords provided by Halyard Health: ultrasonography; peripheral nerve block; peripheral nerve stimulation
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

Participant Flow

Arm/Group Title	USPNB	NSPNB
Arm/Group Description	ultrasound imaging guided peripheral nerve block	Stimulator guided nerve block
Period Title: Overall Study
STARTED	1324	497
COMPLETED	1324	497
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	USPNB	NSPNB	Total
Arm/Group Description	ultrasound imaging guided peripheral nerve block	Stimulator guided nerve block	Total of all reporting groups
Overall Participants	1324	497	1821
Age (Count of Participants)
<=18 years	12 0.9%	0 0%	12 0.7%
Between 18 and 65 years	843 63.7%	306 61.6%	1149 63.1%
>=65 years	469 35.4%	191 38.4%	660 36.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.1 (16.4)	57.7 (17.2)	57.3 (16.6)
Sex: Female, Male (Count of Participants)
Female	649 49%	214 43.1%	863 47.4%
Male	675 51%	283 56.9%	958 52.6%
Region of Enrollment (participants) [Number]
United States	1324 100%	497 100%	1821 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT)

Arm/Group Title	USPNB	NSPNB
Arm/Group Description	Ultrasound imaging guided peripheral nerve block	Nerve Stimulator guided peripheral nerve block
Measure Participants	1324	497
Number [participants]	7 0.5%	14 2.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	USPNB, NSPNB
	Comments	Null hypothesis: There is no difference in reported complications associated with the placement of continuous peripheral nerve block catheters between ultrasound imaging guided placement and nerve stimulator guided placement.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	7 days postoperative
Arm/Group Title	USPNB		NSPNB
Arm/Group Description	ultrasound imaging guided peripheral nerve block		Stimulator guided nerve block
All Cause Mortality
	USPNB		NSPNB
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	USPNB		NSPNB
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1324 (0%)		0/497 (0%)
Other (Not Including Serious) Adverse Events
	USPNB		NSPNB
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/1324 (0.5%)		14/497 (2.8%)
Infections and infestations
Infection	2/1324 (0.2%)	2	2/497 (0.4%)	2
Nervous system disorders
motor block	1/1324 (0.1%)	1	4/497 (0.8%)	4
Vascular disorders
VASCULAR PUNCTURE	4/1324 (0.3%)	4	8/497 (1.6%)	8

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.