Trial Outcomes & Findings for A Device to Determine Return of Sensation From Spinal Block (NCT NCT04553913)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Baseline, from injection and up to 4 hours after injection

Results posted on

2022-04-28

Participant Flow

15 subjects served as their own controls, so only 15 subjects total. Two methods were used to assess the return of sensation on the same side/same non-operative leg after spinal block at the same time

Participant milestones

Participant milestones
Measure	All Participants 15 subjects served as their own controls; two methods were used to assess the return of sensation on the same side/same non-operative leg after spinal block at the same time
Overall Study STARTED	15
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants 15 subjects served as their own controls; two methods were used to assess the return of sensation on the same side/same non-operative leg after spinal block at the same time
Overall Study patient's block resolved prior to PACU	1
Overall Study did not use the device properly	5

Baseline Characteristics

A Device to Determine Return of Sensation From Spinal Block

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Subject Numbers n=15 Participants Subjects in the experimental arm serve as their own control.
Age, Continuous	59.6 years STANDARD_DEVIATION 14.7 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, from injection and up to 4 hours after injection

Population: Applies to experimental site only.

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

Outcome measures

Outcome measures
Measure	Cooling Device Placed n=9 Participants A basic medical grade cooling pad will be secured to the non operative leg. Intermittent coolness will be assessed and subject will inform recovery room staff when sensation returns. cooling device: device placed on patient in recovery on non surgical side to determine resolution of spinal anesthetics.
Block Recovery Time (Device)	40.7 minutes Standard Deviation 33.32

PRIMARY outcome

Timeframe: Baseline, from injection and up to 4 hours after injection

Population: this outcome applies to the standard of care site only

Time to resolution of subarachnoid block (minutes from injection) will be measured for the standard nursing pinprick testing on the same (non-operative) thigh.

Outcome measures

Outcome measures
Measure	Cooling Device Placed n=9 Participants A basic medical grade cooling pad will be secured to the non operative leg. Intermittent coolness will be assessed and subject will inform recovery room staff when sensation returns. cooling device: device placed on patient in recovery on non surgical side to determine resolution of spinal anesthetics.
Block Recovery Time (Pinprick Test)	3.3 minutes Standard Deviation 12.36

SECONDARY outcome

Timeframe: 2 hours after baseline

Population: Data not collected for this outcome.

Percentage of time the temperature sensor displays the pad temperature between 40 and 50 degrees F for the duration of the application

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 hours after baseline

Population: applies only to experimental site group

Outcome measures

Outcome measures
Measure	Cooling Device Placed n=9 Participants A basic medical grade cooling pad will be secured to the non operative leg. Intermittent coolness will be assessed and subject will inform recovery room staff when sensation returns. cooling device: device placed on patient in recovery on non surgical side to determine resolution of spinal anesthetics.
Cooling Pad Temperature (°F) at Stop Switch Activation	53.9 degrees Fahrenheit Standard Deviation 5.6

Adverse Events

All Completed Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Seiha Kim, DO

Atrium Health Wake Forest Baptist

Phone: 336-716-4498

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place