CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
cooling devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04553913
NCT04553913N/ACompleted

Proof-of-Concept: A Device to Determine Return of Sensation After a Regional Anesthetic Block

Wake Forest University Health Sciences·interventional·Posted Sep 18, 2020·Updated Apr 28, 2022

In Brief

A clinical study evaluating cooling device for Sensation Diminished, Pinprick. Completed, enrolled 15 participants across 1 site.

Detailed Summary

Participation in this study will involve having a pad wrapped onto the subject's non-surgical leg to detect when sensation returns after spinal anesthetic and while in recovery room. The pad is part of an approved medical device, but which has been modified and will be used in an experimental way. The device will run cold water through the pad wrapped to the subject's leg. The subject will be asked to press a stop button when they feel the pad gets cold. Nurses in the recovery area will also be testing return of sensation using a standard technique and this will be compared to when the subject begins to feel the cold.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedSep 18, 2020
Enrollment StartDec 8, 2020
Primary CompletionFeb 3, 2021
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 5.8 years ago

Interventions

cooling devicedevice

device placed on patient in recovery on non surgical side to determine resolution of spinal anesthetics.