Sensation Diminished, PinprickNCT04553913
A Device to Determine Return of Sensation From Spinal Block
A study testing cooling device in people with Sensation Diminished, Pinprick, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sensation Diminished, Pinprick
- What is being tested?
- cooling device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2020to 3 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: Proof-of-Concept: A Device to Determine Return of Sensation After a Regional Anesthetic 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. 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.
Read the 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.
- Conditions
- Sensation Diminished, Pinprick
- Being tested
- cooling device
- Keywords
- nerve block, spinal block, local anesthetic, regional anesthesia
- Medical subject headings
- Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cooling deviceDevice
device placed on patient in recovery on non surgical side to determine resolution of spinal anesthetics.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: cooling device |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block Recovery Time (Device)
Time to resolution of subarachnoid block (minutes from injection) will be measured for the device on the (non-operative) thigh.
Measured: 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.
Measured: Baseline, from injection and up to 4 hours after injection
Secondary outcomes (2)
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
Measured: 2 hours after baseline
Cooling Pad Temperature (°F) at Stop Switch Activation
Measured: 2 hours after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start8 Dec 2020
- Primary completion3 Feb 2021
- Study completion3 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sensation Diminished, PinprickStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All participants will have the device placed in the recovery room to determine resolution of regional anesthetics.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seiha Kim, DO, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553913
- Sponsor's protocol ID
- IRB00067142
- Status last verified
- Apr 2022
- First submitted
- 11 Sep 2020
- Last updated
- 28 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-Concept: A Device to Determine Return of Sensation After a Regional Anesthetic Block
- ClinicalTrials.gov ID
- NCT04553913
- Acronym / sponsor ID
- IRB00067142
- Conditions
- Sensation Diminished, Pinprick
- Keywords
- nerve block, spinal block, local anesthetic, regional anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 3 Feb 2021 (actual)
- Study completion
- 3 Feb 2021 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Posted 28 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will have the device placed in the recovery room to determine resolution of regional anesthetics.
| Arm | Type | Receives |
|---|---|---|
| cooling device placed | Experimental | Device: cooling deviceA 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cooling devicedevice placed on patient in recovery on non surgical side to determine resolution of spinal anesthetics. | Device | cooling device placed |
Primary outcome
Block Recovery Time (Device)
Time frame: 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)
Time frame: 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.
2 secondary outcomes
Device Temperature Consistency
Time frame: 2 hours after baseline
Cooling Pad Temperature (°F) at Stop Switch Activation
Time frame: 2 hours after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seiha Kim, DO principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cooling device in people with Sensation Diminished, Pinprick, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Block Recovery Time (Device) (time frame: Baseline, from injection and up to 4 hours after injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.