Percutaneous auricular neuromodulation (nerve stimulation) for the treatment of pain following cholecystectomy and hernia repair: a randomized, double-masked, sham-controlled pilot study.

BACKGROUND: Percutaneous auricular nerve stimulation (neuromodulation) involves implanting electrodes around the ear and administering an electric current. A device is currently available within the USA cleared to treat symptoms from opioid withdrawal, and multiple reports suggest a possible postoperative analgesic effect. The current randomized controlled pilot study was undertaken to (1) determine the feasibility and optimize the protocol for a subsequent definitive clinical trial; and (2) estimate the treatment effect of auricular neuromodulation on postoperative pain and opioid consumption following two ambulatory surgical procedures. METHODS: Within the recovery room following cholecystectomy or hernia repair, an auricular neuromodulation device (NSS-2 Bridge, Masimo, Irvine, California, USA) was applied. Participants were randomized to 5 days of either electrical stimulation or sham in a double-blinded fashion. RESULTS: In the first 5 days, the median (IQR) pain level for active stimulation (n=15) was 0.6 (0.3-2.4) vs 2.6 (1.1-3.7) for the sham group (n=15) (p=0.041). Concurrently, the median oxycodone use for the active stimulation group was 0 mg (0-1), compared with 0 mg (0-3) for the sham group (p=0.524). Regarding the highest pain level experienced over the entire 8-day study period, only one participant (7%) who received active stimulation experienced severe pain, versus seven (47%) in those given sham (p=0.031). CONCLUSIONS: Percutaneous auricular neuromodulation reduced pain scores but not opioid requirements during the initial week after cholecystectomy and hernia repair. Given the ease of application as well as a lack of systemic side effects and reported complications, a definitive clinical trial appears warranted. TRIAL REGISTRATION NUMBER: NCT05521516.

Percutaneous auricular neuromodulation (nerve stimulation) for the treatment of pain following total knee arthroplasty: a randomized, double-masked, sham-controlled pilot study.

BACKGROUND: Percutaneous auricular nerve stimulation (neuromodulation) is an analgesic technique involving the percutaneous implantation of multiple leads at various points on/around the ear followed by the delivery of electric current using an external pulse generator. A device is currently available within the USA cleared to treat symptoms from opioid withdrawal, and multiple reports suggest a possible postoperative analgesic effect. The current randomized, controlled pilot study was undertaken to (1) determine the feasibility and optimize the protocol for a subsequent definitive clinical trial and (2) estimate the treatment effect of auricular neuromodulation on postoperative pain and opioid consumption following total knee arthroplasty. METHODS: Within the recovery room following primary, unilateral, total knee arthroplasty, an auricular neuromodulation device (NSS-2 Bridge, Masimo, Irvine, California, USA) was applied using three percutaneous leads and one ground electrode. Participants were randomized to 5 days of either electrical stimulation or sham stimulation in a double-masked fashion. Participants were discharged with the stimulator in situ and removed the disposable devices at home. The dual primary treatment effect outcome measures were the cumulative opioid use (oral oxycodone) and the mean of the "average" daily pain measured with the Numeric Rating Scale for the first 5 postoperative days. RESULTS: During the first five postoperative days, oxycodone consumption in participants given active stimulation (n=15) was a median (IQR) of 4 mg (2-12) vs 13 mg (5-23) in patients given sham (n=15) treatment (p=0.039). During this same period, the average pain intensity in patients given active stimulation was a median (IQR) of 2.5 (1.5-3.3) vs 4.0 (3.6-4.8) in those given sham (p=0.014). Awakenings due to pain over all eight postoperative nights in participants given active stimulation was a median (IQR) of 5 (3-8) vs 11 (4-14) in those given sham (p<0.001). No device-related localized cutaneous irritation, systemic side effects, or other adverse events were identified. CONCLUSIONS: Percutaneous auricular neuromodulation reduced pain scores and opioid requirements during the initial week after total knee arthroplasty. Given the ease of application as well as the lack of systemic side effects and reported complications, a definitive clinical trial appears warranted. TRIAL REGISTRATION NUMBER: NCT05521516.

Relative Effects of Various Factors on Ice Ball Formation and Ablation Zone Size During Ultrasound-Guided Percutaneous Cryoneurolysis: A Laboratory Investigation to Inform Clinical Practice and Future Research.

INTRODUCTION: Ultrasound-guided percutaneous cryoneurolysis provides analgesia using cold temperatures to reversibly ablate peripheral nerves. Cryoneurolysis probes pass a gas through a small internal annulus, rapidly lowering the pressure and temperature, forming an ice ball to envelope the target nerve. Analgesia is compromised if a nerve is inadequately frozen, and laboratory studies suggest that pain may be paradoxically induced with a magnitude and duration in proportion with the incomplete ablation. We therefore investigated the relative effects of various factors that may contribute to the size of the ice ball and the effective cryoneurolysis zone. METHODS: A cryoprobe was inserted into a piece of meat, a gas was passed through for 2 min, and the resulting ice ball width (cross-section) and length (axis parallel to the probe) were measured using ultrasound, with the temperature evaluated in nine concentric locations concurrently. RESULTS: The factor with the greatest influence on ice ball size was probe gauge: in all probe types, a change from 18 to 14 increased ice ball width, length, and volume by up to 70%, 113%, and 512% respectively, with minimum internal temperature decreasing as much as from -5 to -32 °C. In contrast, alternating the type of meat (chicken, beef, pork) and the shape of the probe tip (straight, coudé) affected ice ball dimensions to a negligible degree. The ice ball dimensions and the zone of adequate temperature drop were not always correlated, and, even within a visualized ice ball, the temperature was often inadequate to induce Wallerian degeneration. CONCLUSIONS: Percutaneous probe design can significantly influence the effective cryoneurolysis zone; visualizing a nerve fully encompassed in an ice ball does not guarantee adequate treatment to induce the desired Wallerian degeneration because ice forms at temperatures between 0 and -20 °C, whereas only temperatures below -20 °C induce Wallerian degeneration. The correlation between temperatures in isolated pieces of meat and perfused human tissue remains unknown, and further research to evaluate these findings in situ appears highly warranted.

Wearable, noninvasive, pulsed shortwave (radiofrequency) therapy for analgesia and opioid sparing following outpatient surgery: A proof-of-concept case series.

BACKGROUND: It is often difficult to concurrently provide adequate analgesia while minimizing opioid requirements following ambulatory surgery. Nonthermal, pulsed shortwave (radiofrequency) fields are a noninvasive treatment used as an adjunct analgesic and wound healing therapy. The devices may be placed by nursing staff in less than a minute, are relatively inexpensive and readily available, theoretically provide analgesia for nearly any anatomic location, and have no systemic side effects-patients cannot detect any sensations from the devices-or significant risks. Here we present a case series to demonstrate the use of pulsed, electromagnetic field devices for outpatient herniorrhaphy and breast surgery. CASE REPORT: Following moderately painful ambulatory umbilical (n = 3) and inguinal (n = 2) hernia repair as well as bilateral breast surgery (n = 2), patients had taped over their surgical incision(s) 1 or 2 noninvasive, wearable, disposable, pulsed shortwave therapy devices (RecoveryRx, BioElectronics Corporation, Frederick, Maryland) which functioned continuously for 30 days. Average resting pain scores measured on the 0-10 numeric rating scale were a median of 0 during the entire treatment period. Six patients avoided opioid use entirely, while the remaining individual required only 5 mg of oxycodone during the first postoperative day. CONCLUSIONS: These cases demonstrate that the ambulatory use of pulsed shortwave devices is feasible and may be an effective analgesic, possibly obviating opioid requirements following outpatient herniorrhaphy and breast surgery. Considering the lack of any side effects, adverse events, and misuse/dependence/diversion potential, further study with a randomized, controlled trial appears warranted.

Percutaneous Auricular Nerve Stimulation (Neuromodulation) for Analgesia and Opioid-Sparing Following Knee and Hip Arthroplasty: A Proof-of-Concept Case Series.

We present a case series to demonstrate proof-of-concept for the off-label use of an auricular neuromodulation device-originally developed to treat symptoms associated with opioid withdrawal-to instead provide analgesia and opioid-sparing following knee and hip arthroplasties. Within the recovery room, an auricular neuromodulation device (near-field stimulator system 2 [NSS-2] Bridge, Masimo) was applied to 5 patients. Average daily pain at rest and while moving was a median of 0 to 2 as measured on the 0 to 10 numeric rating scale, while median daily oxycodone use was 0 to 2.5 mg until device removal at home on postoperative day 5. One patient avoided opioid use entirely.

Treating Intractable Postamputation Pain with Noninvasive, Wearable, Nonthermal, Pulsed Shortwave (Radiofrequency) Therapy: A 12-Patient Case Series.

BACKGROUND Postamputation phantom and residual limb pain are common and frequently intractable, with few reliably effective treatments. Pulsed nonthermal shortwave (radiofrequency) electromagnetic field therapy is a noninvasive treatment used previously as an adjunct analgesic and wound healing therapy. Its use for postamputation pain remains unexamined. CASE REPORT Twelve patients with an above or below knee amputation with persistent, intractable phantom and/or residual limb pain unresponsive to multiple previous invasive treatments were provided with a noninvasive, wearable, pulsed electromagnetic field device (RecoveryRx, BioElectronics Corporation, Frederick, MD, USA). Patients used the included dressings to self-apply the 12 cm-diameter ringed antenna to their residual limb and then activated the device, which delivered nonthermal radiofrequency energy continuously for up to 30 days. Of the 12 individuals, 4 (33%) experienced minimal/no change, 7 (58%) rated their phantom and/or residual limb pain as "very much improved" at the conclusion of treatment, and 1 (8%) patient reported "moderate" improvement, using the Patient Global Impression of Change scale. Of the 8 responders, worst and average phantom limb pain improved a mean (SD) of 4.0 (2.9) and 4.2 (1.8) points on the 0 to 10 numeric rating scale, respectively. Worst and average residual limb pain improved 5.4 (3.7) and 3.5 (2.4) points, respectively. CONCLUSIONS These cases suggest that pulsed electromagnetic field therapy may be an effective treatment for intractable postamputation pain. Considering the low patient burden of noninvasive, wearable devices, combined with few contraindications and no significant side effects or adverse events, further study with a randomized, controlled trial is warranted.

Percutaneous auricular nerve stimulation (neuromodulation) for the treatment of pain following outpatient surgery: a proof-of-concept case series.

BACKGROUND: Following outpatient surgery, it is often difficult to provide adequate analgesia while concurrently minimizing opioid requirements. Ultrasound-guided percutaneous peripheral nerve stimulation has been proposed as an analgesic, but requires physician-level skills, advanced equipment, up to an hour to administer, and is frequently cost prohibitive. In contrast, percutaneous auricular neuromodulation may be placed by nursing staff in a few minutes without additional equipment, theoretically provides analgesia for nearly any anatomic location, lacks systemic side effects, and has no significant risks. We now present a case report to demonstrate proof of concept for the off-label use of an auricular neuromodulation device-originally developed to treat symptoms associated with opioid withdrawal-to instead provide analgesia following outpatient surgery. CASE PRESENTATION: Following moderately painful ambulatory orthopedic and breast surgery, seven patients had an auricular neuromodulation device (NSS-2 Bridge, Masimo, Irvine, California, USA) affixed within the recovery room in approximately 5 min and discharged home. Average resting and dynamic pain scores measured on the 0-10 Numeric Rating Scale were a median of 1 over the first 2 days, subsequently falling to 0. Five patients avoided opioid use entirely, while the remaining two each consumed 5 mg of oxycodone during the first 1-2 postoperative days. After 5 days, the devices were removed at home and discarded. CONCLUSIONS: These cases demonstrate that ambulatory percutaneous auricular neuromodulation is feasible and may be an effective analgesic and decreasing or even negating opioid requirements following outpatient surgery. Considering the lack of systemic side effects, serious adverse events, and misuse/dependence/diversion potential, further study with a randomized, controlled trial appears warranted.

Infection of a Retained Peripheral Nerve Stimulation Lead: A Case Report.

Percutaneous peripheral nerve stimulation is used to provide analgesia for weeks or even months. While infection of any percutaneously implanted object is a concern, it is exceedingly rare for helically coiled leads, with a reported incidence of less than 1 infection for every 32,000 indwelling days. We now report an infected helically coiled lead requiring sedation for extraction and complicated by lead fracture during removal, leaving a remnant in situ. The infection was successfully treated with oral antibiotics. We speculate on the cause of this infection and propose steps to prevent this complication, including the avoidance of sling-to-lead insertion site overlap.