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

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 Overview

• Status: Completed
• Conditions: Neuromuscular Inhibition
• Intervention / Treatment: Procedure: 1 cm; Procedure: 5 cm

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: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Peripheral block score (PBS).	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.	10, 20, and 30 minutes after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	The investigators will examine the difference in the pain scores (0-10 numeric rating scale) between the two groups.	Arrival to PACU (Immediately after surgery, approximately 3-5 hours after intervention)
Analgesia failure rate	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).	Arrival to PACU (Immediately after surgery, approximately 3-5 hours after intervention)
Catheter dislodgement rates	The investigators will examine the difference in the catheter dislodgement rates.	Arrival to PACU (Immediately after surgery, approximately 3-5 hours after intervention)
Difference in total opioid usage	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).	Length of Stay In PACU (Approximately 5-7 hours after intervention)
Degree of Doppler color agitation	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.	Immediately after intervention

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Clifford Bowens, M.D., Vanderbilt University Medical Center

Publications and helpful links

General Publications

• Bowens C Jr, Badiola IJ, Allen BFS, Canlas CL, Gupta RK, Jaeger LM, Briggs ER, Corey JM, Shi Y, Schildcrout JS, Malchow RJ. Color Doppler ultrasonography of an agitated solution is predictive of accurate catheter placement for a continuous popliteal sciatic nerve block. Perioper Med (Lond). 2021 Dec 15;10(1):59. doi: 10.1186/s13741-021-00229-w.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: April 23, 2012
• First Submitted That Met QC Criteria: May 2, 2012
• First Posted (Estimate): May 4, 2012

Study Record Updates

• Last Update Posted (Estimate): July 20, 2015
• Last Update Submitted That Met QC Criteria: July 17, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 120382