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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: Completed Phase 1 study, sponsored by Brigham and Women's Hospital.
NCT04113954 is a Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Pressure (mmHg) in cuff corresponding to pain score 4, 6, 8, and 10 out of 10 based on visual analog scale (VAS)
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 |
What the finished NCT04113954 record still lists
NCT04113954 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 1 intervention - of which Mepivacaine Injection is the first listed.
NCT04113954 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04113954's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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