Effect of transauricular nerve stimulation on perioperative pain: a single-blind, analyser-masked, randomised controlled trial

Patel, Amour; Bibawy, Phillip P.W. M.; Althonayan, Juri; Majeed, Zehra; Gan, Weng L.; Abbott, Tom; Ackland, Gareth L.

doi:10.1016/j.bja.2022.12.025

Cited by 4 publications

(4 citation statements)

References 43 publications

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“…Very few clinical studies have actively sought to measure cardiac autonomic modulation at the same time as the primary outcome has been recorded [17]. Although the assessment of autonomic function is particularly challenging during acute tissue injury in patients, we found that only active transauricular nerve stimulation altered HRV measures indicative of increased baroreflex sensitivity [15]. These data were consistent with our systematic review that identified stimulation parameters that alter heart rate variability [17].…”

Section: Plos Onesupporting

confidence: 84%

“…Patients, clinicians and investigators are blinded to the device allocation throughout data collection and analysis. For active stimulation, the current is typically imperceptible at 3mA [15]. If patients complain or are irritated by the device leads, the current will be reduced by 1mA until the discomfort is no longer reported.…”

Section: Bias and Blindingmentioning

confidence: 99%

“…Bilateral transcutaneous aurciular stimulation is a simple, safe, hand-held, low-cost approach to increase vagal activity and baroreflex sensitivity through non-invasive, painless stimulation of nerves located in the outer ear [17]. We have demonstrated that baroreflex sensitivity can be increased at the bedside by bilateral transcutaneous aurciular stimulation following acute trauma, where the development of baroreflex dysfunction also occurs rapidly after injury [15]. Here, we describe the protocol for a randomised sham-controlled device trial, hypothesizing that bilateral transauricular nerve stimulation lowers blood pressure variability in patients presenting with acute ischaemic stroke through increasing cardiac vagal autonomic tone.…”

Section: Introductionmentioning

confidence: 96%

“…Surgically implanted devices for autonomic neuromodulation, such as vagus nerve stimulators, are impractical in the context of acute stroke. A potential alternative is using non-invasive peripheral neuromodulation devices to attempt to restore autonomic control [15,16]. Bilateral transcutaneous aurciular stimulation is a simple, safe, hand-held, low-cost approach to increase vagal activity and baroreflex sensitivity through non-invasive, painless stimulation of nerves located in the outer ear [17].…”

Section: Introductionmentioning

confidence: 99%

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Transauricular nerve stimulation in acute ischaemic stroke requiring mechanical thrombectomy: Protocol for a phase 2A, proof-of-concept, sham-controlled randomised trial

Ackland,

Martin,

Joseph

et al. 2023

PLoS ONE

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Background Labile blood pressure after acute ischaemic stroke requiring mechanical thrombectomy is independently associated with poor patient outcomes. Objectives This study protocol describes is designed to determine whether transauricular nerve stimulation, improves baroreflex sensitivity, reduces blood pressure variability in the first 24 hours after acute ischaemic stroke requiring mechanical thrombectomy. Design: Phase 2A, proof-of-concept, sham-controlled randomised trial Methods and Analysis: 36 individuals undergoing mechanical thrombectomy for acute ischaemic stroke with established hypertension aged >18 years will be randomly allocated to receive bilateral active or sham transauricular nerve stimulation for the duration of the mechanical thrombectomy procedure (AffeX-CT/001 investigational device). The intervention will be repeated for 1h the morning following the mechanical thrombectomy. Non-invasive blood pressure will be measured ≥2h for 24h after mechanical thrombectomy. Holter electrocardiographic monitoring will be recorded during transauricular nerve stimulation. Participants, clinicians and investigators will be masked to treatment allocations. The primary outcome will be the coefficient of variation of systolic blood pressure. Secondary outcomes include additional estimates of blood pressure variability and time/frequency-domain measures of autonomic cardiac modulation An adjusted sample size of 36 patients is required to have a 90% chance of detecting, as significant at the 5% level, a difference in the coefficient of variation in systolic blood pressure of 5±4mmHg between sham and active stimulation [assuming 5% non-compliance rate in each group]. Ethics: confirmed on 16 March 2023 by HRA and Health and Care Research Wales ethics committee (reference 23/WA/0013) Discussion This study will provide proof-of-concept data that examines whether non-invasive autonomic neuromodulation can be used to favourably modify blood pressure and autonomic control after acute ischaemic stroke requiring mechanical thrombectomy. Trial registration Trial registration number: NCT05417009.

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Section: Plos Onesupporting

confidence: 84%

Section: Bias and Blindingmentioning

confidence: 99%