CompletedNot Applicable

A Device to Determine Return of Sensation From Spinal Block

United States15 participantsStarted 2020-12-08

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Block Recovery Time (Device)

Timeframe: Baseline, from injection and up to 4 hours after injection

Block Recovery Time (Pinprick Test)

Timeframe: Baseline, from injection and up to 4 hours after injection

Trial details

NCT IDNCT04553913

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-02-03

Results submitted2022-02-03

View on ClinicalTrials.gov More Sensation Diminished, Pinprick trials