Peripheral Nerve Injuries Clinical Trial
Official title:
Evaluation of the Diagnostic Threshold of SSEP of Brachial Plexus Injury
NCT number | NCT03409536 |
Other study ID # | SSEP BPI |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2018 |
Est. completion date | December 31, 2019 |
Verified date | February 2020 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Brachial plexus block is a common regional anesthesia technique which is performed by anesthesiologists to anesthetize the arm for surgery. In this study, we are investigating the relationship between the nerve conduction (induced by brachial plexus block) and the patients' symptoms before and after the brachial plexus block. We will attach a nerve conduction device (SSEP device) to monitor the patients' arm conduction and we will assess the patients' symptoms simultaneously.
Status | Completed |
Enrollment | 40 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 95 Years |
Eligibility |
Inclusion Criteria: - All adult patients who are scheduled to have elective upper limb surgeries and require a brachial plexus block as part of their standard of care. Exclusion Criteria: - Patients unable to perform a complete neurological examination (e.g. dementia, upper limb fracture). - Patients who refuse to participate or unable to provide informed consent. - Patients who are contraindicated for SSEP monitoring. - Patients who have known pre-existing peripheral neuropathy or brachial plexus injury. - Patients who are contraindicated to brachial plexus block. - Patients who are not undergoing brachial plexus block for their procedures (e.g. elective C5 nerve root block). - Patients who had failed brachial plexus block. |
Country | Name | City | State |
---|---|---|---|
Canada | St Joeshp Hospital | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
Araus-Galdos E, Delgado P, Villalain C, Martin-Velasco V, Castilla JM, Salazar A. Prevention of brachial plexus injury due to positioning of patient in spinal surgery. Value of multimodal intraoperative neuromonitoring (IONM). Clinical Neurophysiology 2011; 122: S113
Cheney FW, Domino KB, Caplan RA, Posner KL. Nerve injury associated with anesthesia: a closed claims analysis. Anesthesiology. 1999 Apr;90(4):1062-9. — View Citation
Fitzgerald M, McKelvey R. Nerve injury and neuropathic pain - A question of age. Exp Neurol. 2016 Jan;275 Pt 2:296-302. doi: 10.1016/j.expneurol.2015.07.013. Epub 2015 Jul 26. Review. — View Citation
Grocott HP, Clark JA, Homi HM, Sharma A. "Other" neurologic complications after cardiac surgery. Semin Cardiothorac Vasc Anesth. 2004 Sep;8(3):213-26. Review. — View Citation
Kroll DA, Caplan RA, Posner K, Ward RJ, Cheney FW. Nerve injury associated with anesthesia. Anesthesiology. 1990 Aug;73(2):202-7. — View Citation
Larson SJ, Gandhoke GS, Kaur J, et al. Incidence of position related neuropraxia in 4489 consecutive patients undergoing spine surgery. Role of SSEP monitoring? Journal of Neurosurgery 2016; 124 (4): A1182
Sharma AD, Parmley CL, Sreeram G, Grocott HP. Peripheral nerve injuries during cardiac surgery: risk factors, diagnosis, prognosis, and prevention. Anesth Analg. 2000 Dec;91(6):1358-69. Review. — View Citation
Tajiri O, Tateda T, Sugihara H, Yokoyama H, Nishikido O, Mukumoto C. [Brachial plexus neuropathy following open-heart surgery]. Masui. 2004 Apr;53(4):407-10. Japanese. — View Citation
Wojtkiewicz DM, Saunders J, Domeshek L, Novak CB, Kaskutas V, Mackinnon SE. Social impact of peripheral nerve injuries. Hand (N Y). 2015 Jun;10(2):161-7. doi: 10.1007/s11552-014-9692-0. — View Citation
Ying T, Wang X, Sun H, Tang Y, Yuan Y, Li S. Clinical Usefulness of Somatosensory Evoked Potentials for Detection of Peripheral Nerve and Brachial Plexus Injury Secondary to Malpositioning in Microvascular Decompression. J Clin Neurophysiol. 2015 Dec;32(6):512-5. doi: 10.1097/WNP.0000000000000212. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neurological symptoms (including sensory and motor) | Neurological symptoms (including sensory and motor) | 0-30 minutes after receiving the brachial plexus block |
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