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

Not Applicable

Completed

• Conditions: Neuromuscular Inhibition
• Interventions: Procedure: 1 cm; Procedure: 5 cm

• Registration Number: NCT01591603
• Lead Sponsor: Vanderbilt University

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 Timeline

• Study First Submitted: 2012-04-23
• Study Start: 2012-05
• Study First Submitted QC: 2012-05-02
• Study First Posted: 2012-05-04
• Status Verified: 2015-07
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-07-17
• Last Update Posted: 2015-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	1 cm	-
Group 2	5 cm	-

Primary Outcome Measures

Name	Time	Method
Change in Peripheral block score (PBS).	10, 20, and 30 minutes after intervention	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

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

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States