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NCT04553913 · ClinicalTrials.gov registry record · NA

A Device to Determine Return of Sensation From Spinal Block

A NA study of Sensation Diminished, Pinprick, sponsored by Wake Forest University Health Sciences.

Completed
Registry status
NA
Development phase
15
Enrollment target
1
Study location

NCT04553913: Completed NA study of Sensation Diminished, Pinprick, sponsored by Wake Forest University Health Sciences.

NCT04553913 is a NA study of Sensation Diminished, Pinprick that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04553913, a NA study of Sensation Diminished, Pinprick, has completed, sponsored by Wake Forest University Health Sciences.

COMPLETED
Registry status
NA
Development phase
15 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Time to resolution of subarachnoid block (minutes from injection) will be measured for the device on the (non-operative) thigh.

Interventions

  • DEVICE cooling device

Study Locations (1)

North Carolina

  • Wake Forest School of Medicine - Winston-Salem

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2020-12-08
Est. Completion 2021-02-03
Phase NA
Wake Forest University Health Sciences

1,140 total trials

What the finished NCT04553913 record still lists

NCT04553913 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 1 condition, with Sensation Diminished, Pinprick appearing as the primary indexed condition, and to 1 intervention - of which cooling device is the first listed.

NCT04553913 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT04553913 about?

NCT04553913 is a clinical study titled "A Device to Determine Return of Sensation From Spinal Block". 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. T...

What is the current status of trial NCT04553913?

This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2020-12-08. Estimated completion is 2021-02-03.

What conditions does trial NCT04553913 study?

This clinical trial studies the following conditions: Sensation Diminished, Pinprick.

What interventions are being tested in trial NCT04553913?

The interventions under investigation include: cooling device (DEVICE).

Who is sponsoring clinical trial NCT04553913?

This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04553913 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT04553913's enrollment target sits among peer trials

15 1881st of 2000 higher than 92 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT04553913, the US trial registry maintained by the National Library of Medicine. NCT04553913 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.