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Completed

NCT Number: NCT02645097

Ideal Anatomic Location for Saphenous Nerve Blocks: A Prospective Clinical Evaluation

This research is being done to compare two different saphenous nerve block locations and will help to determine which site best maintains knee strength and pain control.

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Key information

Conditions

Foot Injury Ankle Injuries Ankle Injury Foot Injuries Leg Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

About this study

This is a prospective, randomized, observer blinded clinical trial comparing motor strength in knee extension between two sets of patients, one receiving a proximal thigh block of the saphenous nerve and one receiving a distal thigh block of the saphenous nerve. The secondary objectives are to compare the pain relief and quality of life of participants in these two groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-65
  • Upcoming elective foot or ankle surgery

Exclusion criteria

  • Preoperative weakness in knee extension
  • Documented neuropathy
  • Previous knee surgery
  • Inability to provide informed consent

Treatment and study plan

Saphenous nerve block

Procedure

A nerve block will be performed by the anesthesiologist. The location of the nerve block will be per randomization envelope (proximal vs. distal) and performed just prior to foot or ankle surgical procedures that require a saphenous nerve block

Primary outcomes

  1. knee extensor strength measured in kilograms

    Time frame: change from baseline preoperatively to 30 minutes after nerve block placement

    Strength of the knee extensors in both treatment arms (distal vs. proximal block) will be tested preoperatively and again 30 minutes after the nerve block by using a hand-held dynamometer measured in kilograms

Secondary outcomes

  1. pain level

    Time frame: change from baseline preoperatively to two weeks post-operatively

    Pain relief will be measured by review of the medical record for type and amount of pain medications used

  2. quality of life assessment

    Time frame: change from baseline preoperatively to two weeks post-operatively

    PROMIS Global Health Survey will be completed by patients in both treatment arms pre-operatively and again two weeks post-operatively

Sponsors and collaborators

Lead sponsor

Paul J. Juliano, M.D.

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 1, 2016
Registry last updated
Jun 25, 2019

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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