N/A
N=15
A Device to Determine Return of Sensation From Spinal Block
Sensation Diminished, Pinprick
Bottom Line
View on ClinicalTrials.gov: NCT04553913 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Block Recovery Time (Device) — 40.7 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- cooling device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Block Recovery Time (Device) |
40.7 | — |
| PRIMARY Block Recovery Time (Pinprick Test) |
3.3 | — |
| SECONDARY Device Temperature Consistency |
— | — |
| SECONDARY Cooling Pad Temperature (°F) at Stop Switch Activation |
53.9 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT04553913). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.