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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Clifford Bowens, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01591603
First received: April 23, 2012
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Neuromuscular Inhibition
Procedure: 1 cm
Procedure: 5 cm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Perineural Catheter Depth for the Continuous Popliteal Nerve Block Using Ultrasound Guidance and Dermabond

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: May 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 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
Experimental: Group 2 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591603

Contacts
Contact: Jennifer Morse, MS, CCRP 615-936-8495 jennifer.morse@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: Clifford Bowens, MD         
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Clifford Bowens, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: Clifford Bowens, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01591603     History of Changes
Other Study ID Numbers: 120382
Study First Received: April 23, 2012
Last Updated: October 22, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 21, 2014