MedTrace Logo

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

NCT04113954 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-05-14

No results posted yet for this study

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.

Conditions

  • Compartment Syndrome of Leg
  • Healthy

Interventions

DRUG

Mepivacaine Injection

Injection of 0.375% mepivacaine in nerve block

DRUG

Mepivacaine Injection

Injection of 1.5% mepivacaine in nerve block

Sponsors & Collaborators

Principal Investigators

  • Kristin Schreiber, MD/PhD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-29
Primary Completion
2021-04-06
Completion
2021-04-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04113954 on ClinicalTrials.gov