NCT03409536

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

January 18, 2018

Last Update Submit

February 18, 2020

Conditions

Brachial Plexus InjuryPeripheral Nerve Injuries

Keywords

SSEP MonitoringDiagnostic threshold

Outcome Measures

Primary Outcomes (1)

  • Neurological symptoms (including sensory and motor)

    Neurological symptoms (including sensory and motor)

    0-30 minutes after receiving the brachial plexus block

Study Arms (1)

SSEP Monitoring

participants will receive a brachial plexus block for their surgery and will be monitored for brachial plexus injury using the automated SSEP monitor.

Device: SSEP monitoring

Interventions

SSEP monitoringDEVICE

Participants will be monitored using the SSEP device both before and after induction of a brachial plexus block.

SSEP Monitoring

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Joeshp Hospital

London, Ontario, N6G5A5, Canada

Location

Related Publications (11)

  • 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.

    PMID: 26034424BACKGROUND

  • Grocott HP, Clark JA, Homi HM, Sharma A. "Other" neurologic complications after cardiac surgery. Semin Cardiothorac Vasc Anesth. 2004 Sep;8(3):213-26. doi: 10.1177/108925320400800304.

    PMID: 15375481BACKGROUND

  • 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. doi: 10.1097/00000539-200012000-00010. No abstract available.

    PMID: 11093980BACKGROUND

  • 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.

    PMID: 15160668BACKGROUND

  • 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.

    PMID: 26220898BACKGROUND

  • Kroll DA, Caplan RA, Posner K, Ward RJ, Cheney FW. Nerve injury associated with anesthesia. Anesthesiology. 1990 Aug;73(2):202-7. doi: 10.1097/00000542-199008000-00002.

    PMID: 2382845BACKGROUND

  • Cheney FW, Domino KB, Caplan RA, Posner KL. Nerve injury associated with anesthesia: a closed claims analysis. Anesthesiology. 1999 Apr;90(4):1062-9. doi: 10.1097/00000542-199904000-00020.

    PMID: 10201678BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 26629760BACKGROUND

  • 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

    BACKGROUND

  • Chui J, Freytag A, Glimore G, Dhir S, Rachinsky M, Murkin J. A novel approach of using brachial plexus blockade as an experimental model for diagnosis of intraoperative nerve dysfunction with somatosensory evoked potentials: a blinded proof-of-concept study. Can J Anaesth. 2021 Jul;68(7):1018-1027. doi: 10.1007/s12630-021-01975-7. Epub 2021 Mar 31.

    PMID: 33791897DERIVED

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Jason Chui, MBChB

    London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Anesthesiologist

Study Record Dates

First Submitted

January 18, 2018

First Posted

January 24, 2018

Study Start

January 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 19, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)