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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04113954
Other study ID # 2019P002781
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 29, 2020
Est. completion date April 6, 2021

Study information

Verified date May 2021
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Intervention

Drug:
Mepivacaine Injection
Injection of 0.375% mepivacaine in nerve block
Mepivacaine Injection
Injection of 1.5% mepivacaine in nerve block

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Brigham and Women's Hospital Massachusetts Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pressure-pain threshold and tolerance Pressure (mmHg) in cuff corresponding to pain score 4, 6, 8, and 10 out of 10 based on visual analog scale (VAS) 2 hours
Primary Ischemic pain threshold and tolerance Cuff inflation to predetermined pressure (mmHg) corresponding to pain score of 4, 6, 8, and 10 out of 10 based on pressure-pain threshold, and held for up to 5 minutes. Pain scores recorded every 30 seconds, pain scores every 1minute with passive stretch of the gastrocnemius. 2 hours
Primary Ultrasound measurement of pressure in compartment in leg Measurement of ultrasonographic qualities of compartments in the leg using both standard imaging as well shear wave elastography in response to varying external pressure of probe (0-22mmHg) using an external load sensor attached to the probe handle during pressure testing and block recovery, in the absence and presence of a thigh cuff set to 70 mmHg (non-painful pressure). 1 hour
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