Detecting Compartment Syndrome Pain in the Presence of Regional Anesthesia in Healthy Volunteers

Completed · Phase 1

Conditions studied: Compartment Syndrome of Leg, Healthy

In brief

The goal of the study is to determine how different types of Regional Anesthesia (nerve blocks) can be helpful to patients with lower extremity trauma who develop compartment syndrome (an increased pressure in the fascial compartments) which can occur after injury to the leg. This is a prospective, randomized study in healthy volunteers, who will undergo testing of the leg using a cuff inflation system, involving quantitative sensory testing (QST), questionnaire completion, with ultrasound scanning and nerve blocks in a supervised, monitored setting (BWH Clinical Investigation Center). Specific Aims 1. Determine the effect of adductor canal-saphenous nerve block (ACB) and popliteal-fossa nerve block (SNB-PF) vs no block on pressure and ischemic pain in a model of compartment syndrome. 1. Hypothesis: There will be minimal or no change in pressure pain threshold and tolerance and pain ratings with ACB alone 2. Hypothesis: There will be an increase in pressure pain threshold and tolerance and decrease in pain ratings with ACB plus popliteal-fossa nerve block (SNB-PF), compared to no block 2. Determine the concentration dependence of SNB-PF effect on pressure and ischemic pain by comparing increasing doses of local anesthetic. 1. Hypothesis: There will be a greater increase in pressure pain threshold and tolerance and great decrease in pain ratings with 1.5% mepivacaine than with 0.375% mepivacaine.

Key facts

Study ID

NCT04113954

Run by

Brigham and Women's Hospital

People needed

42

Starts

2020-09-29

Expected to finish

2021-04-06

Last updated by the study team

2021-05-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age ≥ 18 years old, ≤ 65 years old
• BMI < 35
• Able to speak and understand English
• Willingness to undergo psychophysical testing
• Willingness to have nerve block performed

You may not qualify if…

• Ongoing acute or chronic pain in lower extremities
• Diagnosis of neuropathy
• Diagnosis of diabetes
• History of chronic opioid use (having an opioid prescription > 30 days)
• Loss of any limb
• Currently pregnant
• Any skin conditions or breakdown of skin affecting lower extremities
• Current history of peripheral arterial disease
• History of blood clot in any lower extremity
• Current smoking/vaping of nicotine or illicit substances including marijuana

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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