NCT04113954

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

Completed Phase 1 Last updated 14 May 2021

What this trial tests

Phase 1 trial testing Mepivacaine Injection in Compartment Syndrome of Leg in 42 participants. Completed in 6 April 2021.

Timeline

29 September 2020

Primary endpoint
6 April 2021

6 April 2021

Quick facts

Lead sponsor	Brigham and Women's Hospital
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	42
Start date	29 September 2020
Primary completion	6 April 2021
Estimated completion	6 April 2021
Sites	1 location across United States

Drugs / interventions tested

• Mepivacaine Injection — full drug profile →
• Mepivacaine Injection — full drug profile →

Conditions studied

• Compartment Syndrome of Leg — all drugs for Compartment Syndrome of Leg →
• Healthy — all drugs for Healthy →

Sponsor

Brigham and Women's Hospital

Who can join

Adults 18 to 65, any sex, with Compartment Syndrome of Leg or Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Impact of varying degrees of peripheral nerve blockade on experimental pressure and ischemic pain: adductor canal and sciatic nerve blocks in a human model of compartment syndrome pain.
   Chen YK, Lirk P, Flowers KM, Colebaugh CA, et al · · 2022 · cited 5× · PMID 35858717 · DOI 10.1136/rapm-2022-103671