Neurometer vs Nerve Stimulator: Block Patients
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Purpose
Anesthetizing nerves in the extremities is an effective way to freeze an area in preparation for surgery. The doctor injects local anesthetic in an appropriate area, interrupting signals from nerves in that area that control movement and sensation. Depending on how much anesthetic is injected, the doctor can impair both movement and sensation or sensation alone. Currently, there are a few methods used to determine how much sensation a patient has in an area, such as testing the patient's response to a pinprick or cold sensation on the skin. Unfortunately, these methods are subjective and don't always give an accurate measurement of how extensive the block is. For this reason, a more accurate and objective method of assessing nerve blocks is needed. We wish to perform a study to test two nerve stimulation devices to compare their ability to give adequate measurements of nerve activity before and after local anesthesia. If we find that a common nerve stimulator can consistently give accurate readings of nerve activity, anesthesiologists may be able to use this device to determine how well a nerve block is working and adjust the patient's anesthesia accordingly.
| Condition | Intervention |
|---|---|
|
Nerve Block Assessment |
Device: Neurometer assessment Device: Nerve stimulator assessment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Percutaneous Nerve Stimulation as a Means to Assess Nerve Block Effectiveness |
- Accuracy of nerve activity measurement. [ Time Frame: During nerve stimulation (approximately 30 seconds for each stimulation test) ] [ Designated as safety issue: No ]Testing whether a common nerve stimulator device detects nerve activity as accurately and consistently as the Neurometer.
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Nerve stimulator
Patients in this group will have their nerve blocks assessed with a common nerve stimulator (Stimuplex HNS 12, B.Braun, Germany).
|
Device: Nerve stimulator assessment
Activity of nerve(s) to be blocked will be assessed with the Stimuplex HNS 12 nerve stimulator before and after administration of local anesthetic.
|
|
Active Comparator: Neurometer
Patients in this group will have their nerve block assessed using the Neurometer.
|
Device: Neurometer assessment
Activity of nerve(s) to be blocked will be assessed with the Neurometer before and after administration of local anesthetic.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult (18 years of age or older) patients who have provided informed consent.
- Outpatients scheduled for elective surgery on the upper or lower extremity or abdomen.
- Requirement for nerve block.
Exclusion Criteria:
- Failure to provide informed consent.
- Neuropathic lesions or polyneuropathic conditions.
- Implanted electrical devices (e.g., pacemaker, spinal cord or peripheral nerve stimulator).
- Allergy to local anesthetics.
- Severe coagulopathy.
- Bilateral upper limb surgery.
Contacts and Locations More Information
Publications:
| Responsible Party: | University of Alberta |
| ClinicalTrials.gov Identifier: | NCT01662154 History of Changes |
| Other Study ID Numbers: | Pro00031858 |
| Study First Received: | July 11, 2012 |
| Last Updated: | May 15, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
ClinicalTrials.gov processed this record on May 16, 2013