A Device to Determine Return of Sensation From Spinal Block

NCT04553913 | Completed Results FDA Device

• 1 other identifier: IRB00067142
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensation Diminished, Pinprick

Keywords

nerve block; spinal block; local anesthetic; regional anesthesia

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Device Temperature Consistency

  2 hours after baseline

• Cooling Pad Temperature (°F) at Stop Switch Activation

  2 hours after baseline

Study Arms (2)

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.

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

Interventions

cooling device DEVICE

device placed on patient in recovery on non surgical side to determine resolution of spinal anesthetics.

cooling device placed

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Somatosensory Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Seiha Kim, DO
• Organization: Atrium Health Wake Forest Baptist

sekim@wakehealth.edu

336-716-4498

Study Officials

• Seiha Kim, DO

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will have the device placed in the recovery room to determine resolution of regional anesthetics.

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 18, 2020
• Study Start: December 8, 2020
• Primary Completion: February 3, 2021
• Study Completion: February 3, 2021
• Last Updated: April 28, 2022
• Results First Posted: April 28, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)