Detection and Prevention of Nerve Injury in Shoulder Arthroplasty Surgery

Neuropathy Clinical Trial

Official title:

Detection and Prevention of Perioperative Nerve Injury Using Automated Somatosensory Evoked Potential Monitoring in Shoulder Arthroplasty Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03624426
• Other study ID #: 108951
• Status: Completed
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: December 2020
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Up to 5% of total shoulder arthroplasty patients experience transient or permanent nerve injury during surgery. In this study, we will monitor the nerve transmission of the patients' arm to detect whether the nerve is functioning normally. This techniques is called somatosensory evoked potential (SSEP) monitoring. In this study, we will assess whether SSEP monitoring could detect nerve abnormalities, alerts the surgical team enabling optimize their surgical intervention and prevent surgical related nerve injury.

Description:

Perioperative PNI is a well-recognized but seriously under-investigated complication of general anesthesia. Arguably, such nerve injury may be viewed as being as devastating as spinal cord and cerebral injury, as the resultant functional disabilities may be very comparable.(1) Many such nerve injured patients require prolonged recovery and rehabilitation, while some result in long-term disability and/or litigation due to motor deficits and chronic pain.(2-5) In ASA Closed Claims Analysis PNI was the second most common cause of claims other than death.(6, 7) However, little progress has been made in the past three decades in developing a reliable intraoperative monitoring technique for early detection and prevention. SSEP monitoring is a potential option for preventing PNI. Abnormal SSEP is widely used as a surrogate outcome for PNI in research studies (8-11). Additionally, previous studies (12-17) investigating the use of SSEP for spinal cord or cerebral injury during neurosurgical procedures have incidentally found high incidences of abnormal SSEP (4-7%) due to mal-positioning that was corrected with repositioning; this suggested SSEP could be used to detect intraoperative PNI and that prompt intervention can reverse PNI. However, there have been no further prospective studies to evaluate the diagnostic value of SSEP, or its outcome benefit. This is largely because conventional SSEP is a bulky, expensive and labor-intensive monitoring modality, requiring a technologist for operation and interpretation.(18) Because of these budgetary and logistical limitations, as well as the relative lack of clinical evidence, SSEP is not performed routinely in most surgical centres solely for the purpose of PNI detection. The recent introduction of the Evoked Potential Assessment Device (EPAD®, SafeOp Surgical, Hunt Valley, MD) may be able to overcome these practical barriers. It is a novel, simplified, automated SSEP monitoring device (FDA approved). The key features of EPAD® are its compactness, ease of connectivity via Bluetooth, and its use of surface adhesive electrodes that remove the potential for needle-stick injuries. This device also incorporates an automated progressive signal optimization algorithm, several newly developed artifact rejection and electrocautery suppression technologies as well as an auto-interpretation diagnostic system. It eliminates the need for a designated technician and permits simplified and direct interpretation of the SSEP data for clinicians in the operating room. This device also enables display and storage of raw SSEP data permitting post hoc area-under-curve analysis. (Fig. 3) We have previously evaluated the clinical utility of this automated SSEP device in 33 cardiac surgical patients (19). This pilot study found that automated SSEP monitoring can be performed readily in a busy cardiac operating room. The raw signal quality is reliable and comparable to the conventional SSEP machine. These results indicate that this device is able to eliminate the practical challenges of performing SSEP monitoring and confirmed its feasibility for routine use.(REB# 104826) Surgical-related nerve injury during TSA is one of the highest risk subspecialties leading to postoperative upper limb peripheral neuropathy with reported incidences of 1-4% (20-22). A previous cohort study10, using motor evoked potential and EMG to evaluate the nerve injury during TSA, reported an exceedingly high incidence of intraoperative alerts (56.7% of patients). Importantly, 76.7% (23 of 30) of nerve alerts were reversed with repositioning of the patients' arm and removal of the retractor. Another cohort study11 in shoulder rotator cuff repair reported an even higher incidence of nerve alert (76.5%). Both studies were received Neer research awards from the Orthopedic Society, however neither study has informed the outcome benefit nor has assessed the relationship between cumulative injury, baseline nerve reserve and postoperative neuropathy. Accordingly, we propose to perform single blinded, superiority, parallel design, prospective randomized controlled study to assess the efficacy of the automated SSEP device in preventing PNI during TSA and explore the dose-response relationship of PNI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 31, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult elective patients undergoing total shoulder arthroplasty surgery using general anesthesia

Exclusion Criteria:

• Patients unable to perform complete neurological examination

• Patients who refuse to participate

• Unable to obtain informed consent.

• Patients who are contraindicated for (or unable to perform) SSEP monitoring

• Patients who have known pre-existing peripheral neuropathy or brachial plexus injury

• Patients who are contraindicated to brachial plexus block

Related Conditions & MeSH terms

• Nerve Injury
• Neuropathy
• Wounds and Injuries

Intervention

Device:
• Automated Somatosensory Evoked Potential device (EPAD@)
After commencement of general anesthesia and during patient positioning, stimulating sensors will be applied to patient wrists and a recording sensor is applied at base of neck posteriorly (at C5 level), forehead and the bilateral wrists. The monitoring will be continued throughout the surgery.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (22)

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

Carofino BC, Brogan DM, Kircher MF, Elhassan BT, Spinner RJ, Bishop AT, Shin AY. Iatrogenic nerve injuries during shoulder surgery. J Bone Joint Surg Am. 2013 Sep 18;95(18):1667-74. doi: 10.2106/JBJS.L.00238. — View Citation

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

Chui J, Murkin JM, Turkstra T, McKenzie N, Guo L, Quantz M. A Novel Automated Somatosensory Evoked Potential (SSEP) Monitoring Device for Detection of Intraoperative Peripheral Nerve Injury in Cardiac Surgery: A Clinical Feasibility Study. J Cardiothorac Vasc Anesth. 2017 Aug;31(4):1174-1182. doi: 10.1053/j.jvca.2016.11.024. Epub 2016 Nov 17. — View Citation

Chung I, Glow JA, Dimopoulos V, Walid MS, Smisson HF, Johnston KW, Robinson JS, Grigorian AA. Upper-limb somatosensory evoked potential monitoring in lumbosacral spine surgery: a prognostic marker for position-related ulnar nerve injury. Spine J. 2009 Apr;9(4):287-95. doi: 10.1016/j.spinee.2008.05.004. Epub 2008 Aug 5. — View Citation

Delaney RA, Freehill MT, Janfaza DR, Vlassakov KV, Higgins LD, Warner JJ. 2014 Neer Award Paper: neuromonitoring the Latarjet procedure. J Shoulder Elbow Surg. 2014 Oct;23(10):1473-80. doi: 10.1016/j.jse.2014.04.003. Epub 2014 Jun 18. — 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

Ho E, Cofield RH, Balm MR, Hattrup SJ, Rowland CM. Neurologic complications of surgery for anterior shoulder instability. J Shoulder Elbow Surg. 1999 May-Jun;8(3):266-70. — View Citation

Jellish WS, Blakeman B, Warf P, Slogoff S. Somatosensory evoked potential monitoring used to compare the effect of three asymmetric sternal retractors on brachial plexus function. Anesth Analg. 1999 Feb;88(2):292-7. — 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

Labrom RD, Hoskins M, Reilly CW, Tredwell SJ, Wong PK. Clinical usefulness of somatosensory evoked potentials for detection of brachial plexopathy secondary to malpositioning in scoliosis surgery. Spine (Phila Pa 1976). 2005 Sep 15;30(18):2089-93. — View Citation

Lädermann A, Lübbeke A, Mélis B, Stern R, Christofilopoulos P, Bacle G, Walch G. Prevalence of neurologic lesions after total shoulder arthroplasty. J Bone Joint Surg Am. 2011 Jul 20;93(14):1288-93. doi: 10.2106/JBJS.J.00369. — 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

Nagda SH, Rogers KJ, Sestokas AK, Getz CL, Ramsey ML, Glaser DL, Williams GR Jr. Neer Award 2005: Peripheral nerve function during shoulder arthroplasty using intraoperative nerve monitoring. J Shoulder Elbow Surg. 2007 May-Jun;16(3 Suppl):S2-8. Epub 2006 Jul 26. — View Citation

Schwartz DM, Drummond DS, Hahn M, Ecker ML, Dormans JP. Prevention of positional brachial plexopathy during surgical correction of scoliosis. J Spinal Disord. 2000 Apr;13(2):178-82. — View Citation

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

Tamkus A, Rice K. Risk of needle-stick injuries associated with the use of subdermal needle electrodes during intraoperative neurophysiologic monitoring. J Neurosurg Anesthesiol. 2014 Jan;26(1):65-8. doi: 10.1097/ANA.0b013e31829b677c. — View Citation

Wilent B, Oppenheimer S. Utlility of nerve monitoring during shoulder arthroplasty. Journal of Clinical Neurophysiology 2012; 29 (6): 536

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

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative duration of abnormal SSEP changes	The cumulative duration (min) of abnormal SSEP changes in the operative arm.	duration of surgery
Secondary	New-onset of peripheral neuropathy	New-onset peripheral neuropathy of the operative arm at postoperative 6 weeks. A thorough neurologic examination will be performed by an independent assessor before (after brachial plexus catheter inserted), and after the surgery (6 weeks). Any new neurological deficit at postoperative 6 weeks that identified by the independent outcomes assessor will be defined as a positive case.	2 weeks, 6 weeks and 3 months
Secondary	American shoulder and elbow surgeons standardized shoulder assessment form	ASES score is a 100 point scale that consists of two dimensions; pain and daily activity. The pain scale is worth 50 points and the daily activity is worth 50 points. 100 points describes being pain- free and able to complete daily activity with no issues while a score of 0 describes extreme pain and unable to complete daily activities.	2 weeks, 6 weeks and 3 months
Secondary	Quality of life measure	The EQ-5D-5L score consists of two components: a descriptive component to assess five dimensions of quality of life and an EQ visual analogue scale (VAS). The EQ-5D health state index is a single summary index, ranging from 0 to 1 (where 0 denotes death and 1 denotes full health/function), that is weighted to the country/region to describe the five dimensions of EQ-5D.	2 weeks, 6 weeks and 3 months