Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cooling device placed | Experimental | 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. |
|
| standard of care no intervention | No Intervention | Subjects in intervention arm will serve as their own control; standard nursing pinprick testing on the same (non-operative) thigh |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cooling device | Device | device placed on patient in recovery on non surgical side to determine resolution of spinal anesthetics. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Block Recovery Time (Device) | Time to resolution of subarachnoid block (minutes from injection) will be measured for the device on the (non-operative) thigh. | Baseline, from injection and up to 4 hours after injection |
| 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. | Baseline, from injection and up to 4 hours after injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 hours after baseline |
| Cooling Pad Temperature (°F) at Stop Switch Activation |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Seiha Kim, DO | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall Subject Numbers | Subjects in the experimental arm serve as their own control. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Applies to experimental site only. | Posted | Mean | Standard Deviation | minutes | Baseline, from injection and up to 4 hours after injection |
|
from baseline through completion of study, an average of four hours
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Completed Subjects | Because subjects served as their own control, both groups included together. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Seiha Kim, DO | Atrium Health Wake Forest Baptist | 336-716-4498 | sekim@wakehealth.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 13, 2020 | Feb 3, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 27, 2020 | Feb 3, 2022 | ICF_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020886 | Somatosensory Disorders |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
Not provided
Not provided
All participants will have the device placed in the recovery room to determine resolution of regional anesthetics.
Not provided
Not provided
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.
Not provided
| 2 hours after baseline |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 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. | this outcome applies to the standard of care site only | Posted | Mean | Standard Deviation | minutes | Baseline, from injection and up to 4 hours after injection |
|
|
|
| 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 | Data not collected for this outcome. | Posted | 2 hours after baseline |
|
|
| Secondary | Cooling Pad Temperature (°F) at Stop Switch Activation | applies only to experimental site group | Posted | Mean | Standard Deviation | degrees Fahrenheit | 2 hours after baseline |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
Not provided
Not provided
Not provided
| D013568 | Pathological Conditions, Signs and Symptoms |