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

Neuromuscular Inhibition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01591603
• Other study ID #: 120382
• Status: Completed
• Phase: N/A
• First received: April 23, 2012
• Last updated: July 17, 2015
• Start date: May 2012
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Neuromuscular Inhibition

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	No