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Completed

NCT Number: NCT01591603

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.

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Key information

Conditions

Neuromuscular Inhibition

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1 cm

Procedure

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

5 cm

Procedure

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

Primary outcomes

  1. Change in Peripheral block score (PBS).

    Time frame: 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 outcomes

  1. Pain score

    Time frame: 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.

  2. Analgesia failure rate

    Time frame: 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).

  3. Catheter dislodgement rates

    Time frame: Arrival to PACU (Immediately after surgery, approximately 3-5 hours after intervention)

    The investigators will examine the difference in the catheter dislodgement rates.

  4. Difference in total opioid usage

    Time frame: 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).

  5. Degree of Doppler color agitation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 4, 2012
Registry last updated
Jul 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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