Comparison of Perineural Catheter Depth for the Continuous Popliteal Nerve Block Using Ultrasound Guidance and Dermabond

This study is currently recruiting participants.

Verified December 2012 by Vanderbilt University

Sponsor:

Information provided by (Responsible Party):

Clifford Bowens, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT01591603

First received: April 23, 2012

Last updated: December 20, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 23, 2012

Last Updated Date

December 20, 2012

Start Date ^ICMJE

May 2012

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in Peripheral block score (PBS). [ Time Frame: 10, 20, and 30 minutes after intervention ] [ Designated as safety issue: No ]

The extent of popliteal nerve blockade will be captured with four sensory groups (sural, superficial peroneal, tibial, and deep peroneal) and three motor groups (superficial peroneal, tibial, and deep peroneal). For each group, a score of 0, 1, or 2 will be assigned based on complete, partial, or no blockade, respectively. The peripheral block score (PBS) outcome variable will be based on the sum of these values and will range from 0 to 14.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01591603 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pain score [ Time Frame: Arrival to PACU (Immediately after surgery, approximately 3-5 hours after intervention) ] [ Designated as safety issue: No ]
The investigators will examine the difference in the pain scores (0-10 numeric rating scale) between the two groups.
Analgesia failure rate [ Time Frame: Arrival to PACU (Immediately after surgery, approximately 3-5 hours after intervention) ] [ Designated as safety issue: No ]
The investigators will examine the difference in analgesia failure rates in the PACU. Analgesia failure is defined as the failure of a rescue bolus (to treat patient pain).
Catheter dislodgement rates [ Time Frame: Arrival to PACU (Immediately after surgery, approximately 3-5 hours after intervention) ] [ Designated as safety issue: No ]
The investigators will examine the difference in the catheter dislodgement rates.
Difference in total opioid usage [ Time Frame: Length of Stay In PACU (Approximately 5-7 hours after intervention) ] [ Designated as safety issue: No ]
The investigators will examine the difference in the total opioid usage. We will compare medications separately and in total equivalent units (using an opioid conversion table).
Degree of Doppler color agitation [ Time Frame: Immediately after intervention ] [ Designated as safety issue: No ]
The investigators will examine the relationship between the degree of Doppler color agitation (evaluated at the time the catheter is placed) and block success (i.e., the outcome in the primary analysis). Degree of agitation color will be defined as the percentage of nerve covered during the color agitation.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of Perineural Catheter Depth for the Continuous Popliteal Nerve Block Using Ultrasound Guidance and Dermabond

Official Title ^ICMJE

Comparison of Perineural Catheter Depth for the Continuous Popliteal Nerve Block Using Ultrasound Guidance and Dermabond

Brief Summary

The study will investigate the difference in success rate between popliteal peripheral nerve catheters placed at 1 centimeter compared to 5 centimeters past the tip of a Tuohy needle.

Detailed Description

Traditionally for the lower extremity, peripheral nerve catheters have been threaded greater than or equal to 5 centimeters past the tip of the Tuohy needle. The major rational for this practice is to reduce dislodgement. However, the greater the distance that a catheter is advanced, the greater the risk of contacting undesired structures, kinking, looping and knotting. For the continuous popliteal nerve block, the catheter is threaded perpendicular to the course of the nerve. This could result in the tip of the catheter being a significant distance from the targeted nerve which may lead to a decrease in the success rate or efficacy of the block.

Greater efficacy may be seen if the needle is closer to its target. This may be quantified by documenting a faster onset of motor and sensory changes and/or a lower catheter infusion rate required to maintain pain control. The study will investigate the difference in success rate between popliteal peripheral nerve catheters placed at 1 centimeter compared to 5 centimeters past the tip of a Tuohy needle.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Neuromuscular Inhibition

Intervention ^ICMJE

Procedure: 1 cm
A Tuohy needle will be advanced in-plane with the bevel cephalad to a point that lies between the tibial and common peroneal branches of the sciatic nerve. The catheter will be advanced 1 cm past the tip of the Tuohy
Other Names:
- 18 gauge 100mm Contiplex Tuohy needle
- 20-gauge non-stimulating catheter
Procedure: 5 cm
A Tuohy needle will be advanced in-plane with the bevel cephalad to a point that lies between the tibial and common peroneal branches of the sciatic nerve. The catheter will be advanced 5 cm past the tip of the Tuohy
Other Names:
- 18 gauge 100mm Contiplex Tuohy needle
- 20-gauge non-stimulating catheter

Study Arm (s)

Experimental: Group 1
Intervention: Procedure: 1 cm
Experimental: Group 2
Intervention: Procedure: 5 cm

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2013

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Will be having a popliteal nerve blocks
Do not meet any of the exclusion criteria listed below.

Exclusion Criteria:

< 18 years old
BMI > 35
Pregnant patients
Diabetes mellitus or patients with known neuropathy
Amputations & polytrauma patients
Patients allergic to local anesthetics
Chronic Pain patients
Patients in whom communication is a problem

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jennifer Morse, MS, CCRP

615-936-8495

jennifer.morse@vanderbilt.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01591603

Other Study ID Numbers ^ICMJE

120382

Has Data Monitoring Committee

Yes

Responsible Party

Clifford Bowens, Vanderbilt University

Study Sponsor ^ICMJE

Vanderbilt University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Clifford Bowens, M.D.

Vanderbilt University

Information Provided By

Vanderbilt University

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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