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NCT04113954 · ClinicalTrials.gov registry record · Phase 1
Detecting Compartment Syndrome Pain in the Presence of Regional Anesthesia in Healthy Volunteers
A Phase 1 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT04113954 is a Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 42 participants.
The verdict
NCT04113954, a Phase 1 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
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.
Interventions
- DRUG Mepivacaine Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2020-09-29 |
| Est. Completion | 2021-04-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04113954
The ClinicalTrials.gov registry entry for NCT04113954 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Mepivacaine Injection is the first listed.
NCT04113954 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04113954 about?
NCT04113954 is a clinical study titled "Detecting Compartment Syndrome Pain in the Presence of Regional Anesthesia in Healthy Volunteers". 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,...
What is the current status of trial NCT04113954?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2020-09-29. Estimated completion is 2021-04-06.
What interventions are being tested in trial NCT04113954?
The interventions under investigation include: Mepivacaine Injection (DRUG).
Who is sponsoring clinical trial NCT04113954?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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