A Device to Determine Return of Sensation From Spinal Block
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: cooling device placed 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. |
Device: cooling device
device placed on patient in recovery on non surgical side to determine resolution of spinal anesthetics.
|
| No Intervention: standard of care no intervention Subjects in intervention arm will serve as their own control; standard nursing pinprick testing on the same (non-operative) thigh |
Outcome Measures
Primary Outcome Measures
- Block Recovery Time (Device) [Baseline, from injection and up to 4 hours after injection]
Time 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 injection]
Time to resolution of subarachnoid block (minutes from injection) will be measured for the standard nursing pinprick testing on the same (non-operative) thigh.
Secondary Outcome Measures
- Device Temperature Consistency [2 hours after baseline]
Percentage 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 Activation [2 hours after baseline]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wake Forest School of Medicine | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Seiha Kim, DO, Wake Forest University Health Sciences
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- IRB00067142
Study Results
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 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | All Participants |
|---|---|
| Arm/Group Description | 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 |
| Period Title: Overall Study | |
| STARTED | 15 |
| COMPLETED | 9 |
| NOT COMPLETED | 6 |
Baseline Characteristics
| Arm/Group Title | Overall Subject Numbers |
|---|---|
| Arm/Group Description | Subjects in the experimental arm serve as their own control. |
| Overall Participants | 15 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
59.6
(14.7)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
7
46.7%
|
| Male |
8
53.3%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
1
6.7%
|
| White |
14
93.3%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
Outcome Measures
| Title | Block Recovery Time (Device) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Applies to experimental site only. |
| Arm/Group Title | Cooling Device Placed |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 9 |
| Mean (Standard Deviation) [minutes] |
40.7
(33.32)
|
| Title | Block Recovery Time (Pinprick Test) |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| this outcome applies to the standard of care site only |
| Arm/Group Title | Standard of Care no Intervention |
|---|---|
| Arm/Group Description | Subjects in intervention arm will serve as their own control; standard nursing pinprick testing on the same (non-operative) thigh |
| Measure Participants | 9 |
| Mean (Standard Deviation) [minutes] |
3.3
(12.36)
|
| Title | Device Temperature Consistency |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data not collected for this outcome. |
| Arm/Group Title | Cooling Device Placed |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 0 |
| Title | Cooling Pad Temperature (°F) at Stop Switch Activation |
|---|---|
| Description | |
| Time Frame | 2 hours after baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| applies only to experimental site group |
| Arm/Group Title | Cooling Device Placed |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 9 |
| Mean (Standard Deviation) [degrees Fahrenheit] |
53.9
(5.6)
|
Adverse Events
| Time Frame | from baseline through completion of study, an average of four hours | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | All Completed Subjects | |
| Arm/Group Description | Because subjects served as their own control, both groups included together. | |
All Cause Mortality |
||
| All Completed Subjects | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/15 (0%) | |
Serious Adverse Events |
||
| All Completed Subjects | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/15 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| All Completed Subjects | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/15 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Seiha Kim, DO |
|---|---|
| Organization | Atrium Health Wake Forest Baptist |
| Phone | 336-716-4498 |
| sekim@wakehealth.edu |
- IRB00067142