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A Device to Determine Return of Sensation From Spinal Block

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04553913
Enrollment
15
Registered
2020-09-18
Start date
2020-12-08
Completion date
2021-02-03
Last updated
2022-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensation Diminished, Pinprick

Keywords

nerve block, spinal block, local anesthetic, regional anesthesia

Brief 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.

Detailed description

Regional anesthesia investigators have always shown interest in measuring the specific duration of neuraxial or peripheral nerve blocks, and how variations in block technique or medications affect that duration. Although ostensibly a simple concept, there are many sensory modalities available for block testing (light touch, cold or hot temperature, pain, pressure, etc.) and there is no consensus in the anesthesia literature on how best to measure the duration of nerve block (. Sensory testing is repetitive, and must be practical and consistent. Pinprick and cold sensation are commonly employed, and these modalities share the same afferent fibers (C-delta) so there is close overlap in the sensory loss mapping after regional block. With respect to pinprick sensation there can be variability in the sharpness, pressure, and reproducibility of a pinprick test. Testing for cold sensation may be more consistent, using a controlled stimulus temperature and duration, and there are different methods of testing such as a cooled glass vial (5℃) or Rolltemp (25℃). Testing for long-acting blocks overnight adds an additional challenge since it requires repetitive subject awakening for assessment, and the interval for testing is a compromise between test specificity and sleep disruption. Again, there is no consensus on the proper interval for testing recovery from regional block. Cold therapy is a commonly applied modality following strenuous exercise or during recovery from extremity surgery, and is expected to reduce tissue damage and relieve pain. There is some evidence of benefit but little consensus on the optimum interval and duration of therapy, and there are many approved medical devices available for use. This investigation proposes an adaptation of an approved cold therapy device to administer automated, periodic cold stimulus at a location made insensate by regional block. When the subject perceives cold at that site, they will press a stop switch to discontinue cooling which will also stop a timer and give an accurate duration of the time to recovery of sensation at that site. The concept will be tested by comparing the duration measured to the standard measurement of recovery from nerve block (spinal) employed by post-anesthesia care unit (PACU) nurses who will use pinprick (toothpick) testing of lumbar dermatomes every thirty minutes. If the device shows acceptable agreement with standard block recovery testing, a follow-up study would be its evaluation for long-duration block testing as an alternative to research assistant repeated testing overnight.

Interventions

DEVICEcooling device

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

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

There is no masking. The PACU nurse will know the patient has the device; the only thing that he/she will not know is when the patient pushed the button to turn off the device.

Intervention model description

All participants will have the device placed in the recovery room to determine resolution of regional anesthetics.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patients 18-75 y/o and scheduled to undergo unilateral primary knee or hip arthroplasty under spinal anesthesia with bupivacaine, ropivacaine or tetracaine will be eligible.

Exclusion criteria

* Patients will be excluded if pre-block sensation is abnormal in the L3 dermatome of the non-operative leg (neuropathy), or if spinal anesthesia is not performed or is unsuccessful. * They will also be excluded if sensation has already returned in the L3 dermatome on arrival to the PACU.

Design outcomes

Primary

MeasureTime frameDescription
Block Recovery Time (Device)Baseline, from injection and up to 4 hours after injectionTime to resolution of subarachnoid block (minutes from injection) will be measured for the device on the (non-operative) thigh.
Block Recovery Time (Pinprick Test)Baseline, from injection and up to 4 hours after injectionTime to resolution of subarachnoid block (minutes from injection) will be measured for the standard nursing pinprick testing on the same (non-operative) thigh.

Secondary

MeasureTime frameDescription
Device Temperature Consistency2 hours after baselinePercentage of time the temperature sensor displays the pad temperature between 40 and 50 degrees F for the duration of the application
Cooling Pad Temperature (°F) at Stop Switch Activation2 hours after baseline

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

ArmCount
Overall Subject Numbers
Subjects in the experimental arm serve as their own control.
15
Total15

Withdrawals & dropouts

PeriodReasonFG000
Overall Studydid not use the device properly5
Overall Studypatient's block resolved prior to PACU1

Baseline characteristics

CharacteristicOverall Subject Numbers
Age, Continuous59.6 years
STANDARD_DEVIATION 14.7
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
14 Participants
Sex: Female, Male
Female
7 Participants
Sex: Female, Male
Male
8 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 15
other
Total, other adverse events
0 / 15
serious
Total, serious adverse events
0 / 15

Outcome results

Primary

Block Recovery Time (Device)

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

Time frame: Baseline, from injection and up to 4 hours after injection

Population: Applies to experimental site only.

ArmMeasureValue (MEAN)Dispersion
Cooling Device PlacedBlock Recovery Time (Device)40.7 minutesStandard Deviation 33.32
Primary

Block Recovery Time (Pinprick Test)

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

Time frame: Baseline, from injection and up to 4 hours after injection

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

ArmMeasureValue (MEAN)Dispersion
Cooling Device PlacedBlock Recovery Time (Pinprick Test)3.3 minutesStandard Deviation 12.36
Secondary

Cooling Pad Temperature (°F) at Stop Switch Activation

Time frame: 2 hours after baseline

Population: applies only to experimental site group

ArmMeasureValue (MEAN)Dispersion
Cooling Device PlacedCooling Pad Temperature (°F) at Stop Switch Activation53.9 degrees FahrenheitStandard Deviation 5.6
Secondary

Device Temperature Consistency

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

Time frame: 2 hours after baseline

Population: Data not collected for this outcome.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026