Spinal Anesthesia or General Anesthesia for Hip Surgery in Older Adults.

BACKGROUND: The effects of spinal anesthesia as compared with general anesthesia on the ability to walk in older adults undergoing surgery for hip fracture have not been well studied. METHODS: We conducted a pragmatic, randomized superiority trial to evaluate spinal anesthesia as compared with general anesthesia in previously ambulatory patients 50 years of age or older who were undergoing surgery for hip fracture at 46 U.S. and Canadian hospitals. Patients were randomly assigned in a 1:1 ratio to receive spinal or general anesthesia. The primary outcome was a composite of death or an inability to walk approximately 10 ft (3 m) independently or with a walker or cane at 60 days after randomization. Secondary outcomes included death within 60 days, delirium, time to discharge, and ambulation at 60 days. RESULTS: A total of 1600 patients were enrolled; 795 were assigned to receive spinal anesthesia and 805 to receive general anesthesia. The mean age was 78 years, and 67.0% of the patients were women. A total of 666 patients (83.8%) assigned to spinal anesthesia and 769 patients (95.5%) assigned to general anesthesia received their assigned anesthesia. Among patients in the modified intention-to-treat population for whom data were available, the composite primary outcome occurred in 132 of 712 patients (18.5%) in the spinal anesthesia group and 132 of 733 (18.0%) in the general anesthesia group (relative risk, 1.03; 95% confidence interval [CI], 0.84 to 1.27; P = 0.83). An inability to walk independently at 60 days was reported in 104 of 684 patients (15.2%) and 101 of 702 patients (14.4%), respectively (relative risk, 1.06; 95% CI, 0.82 to 1.36), and death within 60 days occurred in 30 of 768 (3.9%) and 32 of 784 (4.1%), respectively (relative risk, 0.97; 95% CI, 0.59 to 1.57). Delirium occurred in 130 of 633 patients (20.5%) in the spinal anesthesia group and in 124 of 629 (19.7%) in the general anesthesia group (relative risk, 1.04; 95% CI, 0.84 to 1.30). CONCLUSIONS: Spinal anesthesia for hip-fracture surgery in older adults was not superior to general anesthesia with respect to survival and recovery of ambulation at 60 days. The incidence of postoperative delirium was similar with the two types of anesthesia. (Funded by the Patient-Centered Outcomes Research Institute; REGAIN ClinicalTrials.gov number, NCT02507505.).

Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation of C2 Dorsal Root Ganglion for the Treatment of Refractory Atypical Facial Pain: A Technical Report and Case Series.

BACKGROUND: Chronic craniofacial pain can be difficult to manage clinically. This technical report documents the peripheral nerve stimulation of the C2 dorsal root ganglion as an effective modality to treat refractory atypical facial pain. MATERIALS AND METHODS: In this case series, three patients with chronic refractory atypical facial pain and p >50% pain relief following diagnostic C2 dorsal root ganglion blockade underwent ultrasound-guided percutaneous placement of a peripheral nerve stimulator adjacent to the C2 dorsal root ganglion. Patients were then observed clinically and monitored for improvement in symptoms and adverse events. RESULTS: Three patients underwent peripheral nerve stimulator placement. At follow-up, there were no reported adverse events, and all patients reported satisfactory improvement in pain. CONCLUSION: The neuromodulation of C2 dorsal root ganglion via ultrasound-guided percutaneously implanted peripheral nerve stimulator is a novel and potentially effective approach for the management of chronic refractory craniofacial pain.

The Effect of Intraoperative Systemic Lidocaine on Postoperative Persistent Pain Using Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials Criteria Assessment Following Breast Cancer Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial.

OBJECTIVE: To compare the incidence in postsurgical persistent pain following breast cancer surgery in women receiving intravenous lidocaine compared to saline using validated pain instruments in accordance with the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations. METHODS: The study was a randomized, double-blinded, placebo-controlled, clinical trial. Subjects were randomized into Group 1 (1.5 mg/kg bolus of intravenous lidocaine followed by a 2 mg/kg/hour infusion) or Group 2 (normal saline at the same bolus and infusion rate). Patients were evaluated at 3 and 6 months for the presence of chronic persistent postsurgical pain. RESULTS: One hundred forty-eight patients were included in the study analysis. There were no differences in quality of recovery, pain burden, or opioid consumption between groups at 24 hours. Pain (yes/no) at 6 months attributed to surgery was reported in 29% of Group 2 vs. 13% of Group 1 patients (P = 0.04); however, only 3 subjects (5%) in Group 1 and 2 subjects (3%) in Group 2 met IMMPACT criteria for persistent postoperative pain (P = 0.99). DISCUSSION: Perioperative infusion of lidocaine has been reported to decrease the incidence of postsurgical pain at 3 and 6 months following mastectomy using dichotomous (yes/no) scoring. Although intravenous lidocaine reduced the reported incidence of pain at rest at 6 months, pain with activity, pain qualities, and the physical or emotional impact of the pain were unaffected. Future studies evaluating postsurgical persistent pain should adhere to the IMMPACT recommendations in order to more accurately describe the effect of an intervention on persistent pain.

Peripheral nerve blocks of wrist and finger flexors can increase hand opening in chronic hemiparetic stroke.

Introduction: Hand opening is reduced by abnormal wrist and finger flexor activity in many individuals with stroke. This flexor activity also limits hand opening produced by functional electrical stimulation (FES) of finger and wrist extensor muscles. Recent advances in electrical nerve block technologies have the potential to mitigate this abnormal flexor behavior, but the actual impact of nerve block on hand opening in stroke has not yet been investigated. Methods: In this study, we applied the local anesthetic ropivacaine to the median and ulnar nerve to induce a complete motor block in 9 individuals with stroke and observed the impact of this block on hand opening as measured by hand pentagonal area. Volitional hand opening and FES-driven hand opening were measured, both while the arm was fully supported on a haptic table (Unloaded) and while lifting against gravity (Loaded). Linear mixed effect regression (LMER) modeling was used to determine the effect of Block. Results: The ropivacaine block allowed increased hand opening, both volitional and FES-driven, and for both unloaded and loaded conditions. Notably, only the FES-driven and Loaded condition's improvement in hand opening with the block was statistically significant. Hand opening in the FES and Loaded condition improved following nerve block by nearly 20%. Conclusion: Our results suggest that many individuals with stroke would see improved hand-opening with wrist and finger flexor activity curtailed by nerve block, especially when FES is used to drive the typically paretic finger and wrist extensor muscles. Such a nerve block (potentially produced by aforementioned emerging electrical nerve block technologies) could thus significantly address prior observed shortcomings of FES interventions for individuals with stroke.

Permanent Peripheral Nerve Stimulator for Complex Regional Pain Syndrome of the Forearm and Hand.

A 51-year-old woman with diabetes and depression was referred to the anesthesia pain clinic with a 15-year history of complex regional pain syndrome type I of the right forearm and hand in the radial sensory nerve distribution. There was no recognized antecedent trauma and she had failed both medical treatment and radial sensory nerve decompression surgery. An ultrasound-guided local anesthetic block of the radial nerve in the upper arm resulted in partial and temporary improvement in pain. She subsequently underwent trial of a peripheral nerve stimulator (PNS) followed by permanent PNS implant placement over the radial nerve proper proximal to the elbow. Within the first month of use, she endorsed substantially improved pain and strength in her right hand. These improvements were sustained for more than 1 year. Applications of PNS technology for treatment of extremity complex regional pain syndrome and neuropathic extremity pain in general are reviewed.

A randomized trial of epidural analgesia followed by continuous femoral analgesia compared with oral opioid analgesia on short- and long-term functional recovery after total knee replacement.

OBJECTIVE: The purpose of this study was to compare continuous femoral nerve analgesia to oral opioid analgesics after discontinuation of epidural analgesia following total knee replacement. DESIGN: Randomized prospective controlled parallel group trial. Setting. Large tertiary university teaching hospital in a major Midwestern city. Subjects. Sixty-two subjects were randomized to receive neuraxial anesthesia followed by either oral analgesics (N = 31) or continuous femoral nerve analgesia (N = 31). INTERVENTIONS: After discontinuation of epidural anesthesia on the morning after surgery, continuous femoral nerve analgesia (CFA), ropivacaine 25 mg bolus and 5 mg/h infusion was initiated. Catheters were removed 24 hours later. All subjects received oral opioid analgesics as needed. OUTCOME MEASURES: The primary outcome measure was knee flexion at 1 month. Physical therapy assessments, pain scores, opioid consumption, and patient satisfaction were assessed during hospitalization. Knee flexion, pain scores, and opioid consumption were collected at 1, 6, and 12 months, and health-related quality of life was collected at 6 and 12 months. RESULTS; The median difference (95% CI) in the change in knee flexion from baseline was 7.5 (0 to 15) degrees greater after CFA (P = 0.04) at 1 month. CFA subjects had greater compliance with physical therapy, reduced pain scores, and opioid requirements during hospitalization. Thromboembolic events occurred in 0/31 CFA vs 4/31 non-CFA subjects (P = 0.04). CONCLUSIONS: CFA for 24 hours following discontinuation of epidural analgesia was associated with lower pain scores, greater compliance with physical therapy, increased range of motion, reduced opioid analgesia use, and greater patient satisfaction during hospitalization. The increased flexion of the operated joint was still evident at 1 month postoperatively.

Nerve stimulator-guided supplemental popliteal sciatic nerve block after a failed sciatic block does not increase the incidence of transient postoperative neurologic sequelae.

BACKGROUND: Supplemental peripheral nerve blocks are not commonly performed in adults because of concerns of cumulative exposure of the nerve to the local anesthetic as well as increased ischemia from epinephrine. The purpose of this study was to compare the incidence of postoperative neurologic symptoms after a failed subgluteal sciatic nerve block and a supplemental popliteal sciatic nerve block. METHODS: Five hundred twelve adult patients undergoing ambulatory surgery were prospectively studied (1 yr). Sciatic nerve blocks were performed using levobupivacaine 0.625% with epinephrine 1:200,000 (0.5 ml/kg). Patients who failed to achieve sensory and motor anesthesia at 30-60 min were given a popliteal sciatic nerve block (lidocaine 2% 10 ml + levobupivacaine 0.5% 10 ml). Subjects were contacted at 24 h to 48 h, 2 weeks, and 1 month. Symptomatic patients were contacted biweekly and reevaluated during follow-up surgeon visits until symptom resolution. RESULTS: Four hundred thirty-nine subjects were analyzed. Fifty-six received a popliteal sciatic nerve block. Four subjects (0.9%) had self-reported neurologic symptoms in the distribution of the sciatic nerve. Investigator-initiated follow-up revealed 33 subjects (8.7%) who received a single subgluteal sciatic block and 4 subjects (7.1%) after a supplemental sciatic nerve block with neurologic symptoms (P = 0.80). The median duration of symptoms was 4 weeks (95% CI 3-5) in the subgluteal and 4 weeks (95% CI 3-5) weeks in the popliteal group (P = 0.98). All symptoms resolved by 14 weeks postprocedure. CONCLUSION: Blocking the sciatic nerve at a more distal site after a failed subgluteal sciatic nerve block does not appear to influence the incidence or duration of neurologic sequelae.

American Society of Regional Anesthesia and Pain Medicine expert panel recommendations on point-of-care ultrasound education and training for regional anesthesiologists and pain physicians-part II: recommendations.

Point-of-care ultrasound (POCUS) is a critical skill for all regional anesthesiologists and pain physicians to help diagnose relevant complications related to routine practice and guide perioperative management. In an effort to inform the regional anesthesia and pain community as well as address a need for structured education and training, the American Society of Regional Anesthesia and Pain Medicine Society (ASRA) commissioned this narrative review to provide recommendations for POCUS. The recommendations were written by content and educational experts and were approved by the guidelines committee and the Board of Directors of the ASRA. In part II of this two-part series, learning goals and objectives were identified and outlined for achieving competency in the use of POCUS, specifically, airway ultrasound, lung ultrasound, gastric ultrasound, the focus assessment with sonography for trauma exam, and focused cardiac ultrasound, in the perioperative and chronic pain setting. It also discusses barriers to POCUS education and training and proposes a list of educational resources. For each POCUS section, learning goals and specific skills were presented in the Indication, Acquisition, Interpretation, and Medical decision-making framework.

American Society of Regional Anesthesia and Pain Medicine expert panel recommendations on point-of-care ultrasound education and training for regional anesthesiologists and pain physicians-part I: clinical indications.

Point-of-care ultrasound (POCUS) is a critical skill for all regional anesthesiologists and pain physicians to help diagnose relevant complications related to routine practice and guide perioperative management. In an effort to inform the regional anesthesia and pain community as well as address a need for structured education and training, the American Society of Regional Anesthesia and Pain Medicine (ASRA) commissioned this narrative review to provide recommendations for POCUS. The guidelines were written by content and educational experts and approved by the Guidelines Committee and the Board of Directors of the ASRA. In part I of this two-part series, clinical indications for POCUS in the perioperative and chronic pain setting are described. The clinical review addresses airway ultrasound, lung ultrasound, gastric ultrasound, the focus assessment with sonography for trauma examination and focused cardiac ultrasound for the regional anesthesiologist and pain physician. It also provides foundational knowledge regarding ultrasound physics, discusses the impact of handheld devices and finally, offers insight into the role of POCUS in the pediatric population.

Factor VII levels and international normalized ratios in the early phase of warfarin therapy.

BACKGROUND: Factor VII is the most affected clotting factor during the early phase of warfarin therapy. An international normalized ratio (INR) of more than 1.4 is considered unsafe for epidural catheter placement or removal, according to the American Society of Regional Anesthesia and Pain Medicine. The authors tested the hypothesis that factor VII activities would be consistent with safe removal of the epidural catheter on postoperative day (POD) 1 regardless of INR value. METHODS: Data from 121 patients who took warfarin after undergoing total joint surgery and had INRs and factor VII levels determined were reviewed. Patient characteristics and factor VII activities were compared between patients with INRs of more than 1.4 and those with INRs less than or equal to 1.4 on PODs 1, 2, and 3. RESULTS: Eleven patients had INRs of more than 1.4 on POD 1; their mean +/- SD factor VII activities were 60 +/- 28% (normal: 50-160%). On POD 2, 78 patients with INRs more than of 1.4 had factor VII activities of 32 +/- 15%, whereas on POD 3, 84 patients with INRs of more than 1.4 had factor VII activities of 44 +/- 19%. Variables included in the final multiple logistic regression model as predictors of an INR of more than 1.4 on POD 2 were warfarin dose on POD 1 and factor VII activity on POD 2. CONCLUSIONS: The range of factor VII activities in the patients with INRs of more than 1.4 within 12 h of warfarin therapy was compatible with adequate hemostasis. The authors found no evidence that epidural catheters should not be removed even with INRs up to 1.9, the highest INR on POD 1 noted in their study.

Sensory testing of distal sural and posterior tibial nerves provides early prediction of surgical anesthesia after single-injection infragluteal-parabiceps sciatic nerve block.

BACKGROUND: Surgical anesthesia for reconstructive ankle surgery requires sensory and motor block of all the terminal nerve distributions of the sciatic nerve. In this prospective observational study, we investigated the value of sensory and motor testing of the foot, after local anesthetic injection, for predicting complete sciatic nerve blockade and the duration of testing required for identifying incomplete anesthesia. METHODS: Sciatic nerve blocks (n = 180) using the infragluteal-parabiceps approach were performed in patients undergoing reconstructive ankle surgery. Levobupivacaine 0.625% with epinephrine 1:300,000 (0.4 mL/kg) was injected after obtaining an elicited motor response at <0.4 mA of plantar flexion or inversion. Pinprick sensory assessments were performed at intervals by an observer unaware of the elicited motor response in the distal cutaneous distributions of the superficial peroneal nerve, deep peroneal nerve, posterior tibial nerve, and sural nerve. Motor block was assessed using foot (plantar flexion and dorsiflexion) movement and toe movement. A complete block was defined as sensory and motor loss in all distributions of the sciatic nerve within 25 minutes of local anesthetic injection. The optimal sensitivity and specificity of various cutoff times of sensory and motor testing were determined by receiver operating characteristic analysis. The area under the curves was compared for equivalence using nonparametric methods. The cutoff times were determined as the point of intersection of the lines of sensitivity and specificity. RESULTS: The elicited evoked motor response before sciatic nerve block was plantar flexion in 87 patients and inversion in 93. Eighty-eight of 93 patients (94.6%) who had an elicited motor response of inversion and 49 of 87 (55.7%) who had an elicited motor response of plantar flexion achieved complete sciatic nerve block at 25 minutes. Area under the curves were not different among testing paradigms. Receiver operating characteristic analysis identified optimal testing times of 4 minutes for the sural and 6 minutes for the posterior tibial nerve with an elicited motor response of inversion and 6 minutes with an elicited motor response of plantar flexion. No subject with an incomplete block achieved sural anesthesia by 10 minutes. CONCLUSION: Sural anesthesia assessed at the lateral heel and the lateral aspect of the foot and the fifth toe identified within 4 to 6 minutes demonstrated a similar posttest predictive value as anesthesia in the distributions of the posterior tibial and peroneal nerves or motor movement of the foot at later intervals. In addition, failure to achieve sural anesthesia within 10 minutes was predictive of block failure.

Technical considerations for approaches to the ultrasound-guided maxillary nerve block via the pterygopalatine fossa: a literature review.

BACKGROUND AND OBJECTIVES: Blockade of the trigeminal nerve and its branches is an effective diagnostic tool and potential treatment of facial pain. Ultrasound-guided injections in the pterygopalatine fossa (PPF) to block the trigeminal nerve divisions and sphenopalatine ganglion have been described but a consensus has yet to be reached over the ideal approach. We sought to delineate and compare the various approaches to the ultrasound-guided trigeminal divisions blockade via the PPF. METHODS: The literature search was performed by searching the National Library of Medicine's PubMed database, the Cochrane Database of Systematic Reviews and Google Scholar within the date range of January 2009-March 2019 for keywords targeted toward "trigeminal nerve," "maxillary nerve," or "pterygopalatine fossa," "ultrasound," and "nerve block," using an English language restriction. Six papers were included in the final review: one prospective double-blinded randomized controlled trial, one prospective descriptive study, one case series, two case reports, and one cadaveric study. RESULTS: There are three main approaches to the ultrasound-guided trigeminal nerve branches blockade via the PPF: anterior infrazygomatic in-plane, posterior infrazygomatic in-plane, and suprazygomatic out-of-plane approaches. Each showed injectate spread to the PPF in cadaver, adult and pediatric patients, respectively.1-5 Injectate used varied from 3 to 5 mL to 0.15 mL/kg. CONCLUSIONS: These studies demonstrated that the PPF is a readily accessible target for the ultrasound-guided maxillary nerve block via three main approaches.2 The ideal approach is yet to be determined and must be further explored.

Thoracoscopic lung biopsy under regional anesthesia for interstitial lung disease.

BACKGROUND: Interstitial lung disease (ILD) management guidelines support lung biopsy-guided therapy. However, the high mortality associated with thoracoscopic lung biopsy using general anesthesia (GA) in patients with ILD has deterred physicians from offering this procedure and adopt a diagnostic approach based on high-resolution CT. Here we report that thoracoscopy under regional anesthesia could be a safer alternative for lung biopsy and effectively guide ILD treatment. METHODS: This was a single-center retrospective review of prospectively maintained database and consisted of patients who underwent thoracoscopic lung biopsy between March 2016 and March 2018. Patients were divided into two groups: (A) GA, and (B) regional anesthesia using monitored anesthesia care (MAC) and thoracic epidural anesthesia (TEA). RESULTS: During the study period, 44 patients underwent thoracoscopic lung biopsy. Of these, 15 underwent MAC/TEA. There were no significant differences between the two groups with regard to pulmonary function test and clinicodemographic profile. However, operative time and hospital stay were shorter in MAC/TEA group (32.5±18.5 min vs 50.8±18.4; p=0.004, 1.0±1.3 days vs 10.0±34.7 days; p<0.001, respectively). Eight patients in the GA group, but none in the MAC/TEA group, experienced worsening of ILD after lung biopsy (p=0.03). Additionally, one patient in the GA group died due to acute ILD worsening. No cases of MAC/TEA group had to be converted to GA. In all cases a pathological diagnosis could be made. CONCLUSIONS: Thoracoscopy using regional anesthesia might be a safer alternative to lung biopsy in patients with ILD.

A randomized comparison of a modified intertendinous and classic posterior approach to popliteal sciatic nerve block.

INTRODUCTION: In this prospective randomized study, we compared a single-injection modified intertendinous (n = 55) with the classic posterior (n = 54) popliteal sciatic nerve block for patients undergoing ankle/foot surgery. METHODS: Nerve stimulator-guided blocks were performed 7-8 cm (classic posterior) or 12-14 cm (modified intertendinous) above the popliteal crease. Levobupivacaine 0.625% with epinephrine 1:300,000 (Chirocaine(R), Purdue Pharma, Stamford, CT), was injected in 5 mL aliquots to a total volume of 0.4 mL/kg (range, 25-35 mL). The needle position was considered acceptable if an evoked motor response of plantar flexion, inversion, eversion or a dorsiflexion of the ipsilateral foot was elicited at

Ultrasound-assisted and evoked motor response stimulation of the deep peroneal nerve.

BACKGROUND: We performed an observational volunteer study to document an ultrasound-guided evoked motor response blockade of the deep peroneal nerve. METHODS: Sixteen volunteers had deep peroneal nerve blocks in each foot. After visualization of the artery and the deep peroneal nerve with an ultrasound, the nerve was stimulated with a nerve stimulator. Evoked motor responses and/or paresthesia were noted before injection of the local anesthetic. RESULTS: Any evoked motor response (extension of the toes or muscle contractions on the dorsum of the lateral aspect of the foot) or elicitation of paresthesia resulted in complete sensory blockade of the web between the big toe and second toe. CONCLUSIONS: Visualization of the deep peroneal nerve with ultrasound followed by elicitation of an evoked motor response, or paresthesia, predicts successful blockade of the deep peroneal nerve.

Relationship between ultrasound imaging and eliciting motor response during femoral nerve stimulation.

OBJECTIVE: Nerve stimulator-assisted localization of the femoral nerve is well described; however, direct ultrasound imaging of the femoral nerve branches may be challenging. The purpose of this study was to correlate the evoked motor responses obtained by femoral nerve stimulation and the topographic orientation of the femoral nerve branches during ultrasound examinations of the infrainguinal region. METHODS: Eighty-two patients undergoing total knee replacement were enrolled in this study. A 25-mm, 5- to 10-MHz broadband linear array transducer was used to identify the femoral nerve at the inguinal crease. The medial and lateral aspects of the femoral nerve were stimulated under ultrasound imaging. Twenty cadavers were dissected to support our clinical findings. RESULTS: A quadriceps contraction was elicited in 1.2% and 96% of the patients when stimulating the medial and lateral aspects of the femoral nerve, respectively. In contrast, a sartorius muscle contraction was elicited in 94% and 0% when stimulating the medial and lateral aspects of the femoral nerve. Our findings during anatomic dissection revealed that the femoral nerve branch to the quadriceps muscle, when compared with the branch to the sartorius muscle, originated laterally in 95% and medially in 5% of the specimens. CONCLUSIONS: When using out-of-plane ultrasound imaging at the inguinal crease, directing the stimulating needle to the lateral half of the femoral nerve may be associated with a higher probability of encountering the motor branch to the quadriceps muscle.

Ultrasound-Guided Pulsed Radiofrequency of C2 Dorsal Root Ganglion as Adjuvant Treatment for Chronic Headache Disorders: A Case Report.

Cluster headaches are characterized by unilateral sudden onset of intense, brief, sharp pain along the side of the face around the eye. Patients often can have symptoms that are resistant to medications, nerve blocks, and surgical treatments. There is increasing evidence of anatomical and functional connections between the trigeminal and occipital nerves. We present a patient with cluster headache presenting with chronic ipsilateral facial pain with nasal congestion and left eye pain who achieved sustained pain relief with an ultrasound-guided injection into the pterygopalatine fossa in conjunction with an ultrasound-guided pulsed radiofrequency ablation procedure involving the C2 dorsal root ganglion.

Percutaneous peripheral nerve stimulation for the treatment of chronic neuropathic postamputation pain: a multicenter, randomized, placebo-controlled trial.

BACKGROUND AND OBJECTIVES: Chronic neuropathic pain is a common challenging condition following amputation. Recent research demonstrated the feasibility of percutaneously implanting fine-wire coiled peripheral nerve stimulation (PNS) leads in proximity to the sciatic and femoral nerves for postamputation pain. A multicenter, double-blinded, randomized, placebo-controlled study collected data on the safety and effectiveness of percutaneous PNS for chronic neuropathic pain following amputation. METHODS: Twenty-eight lower extremity amputees with postamputation pain were enrolled. Subjects underwent ultrasound-guided implantation of percutaneous PNS leads and were randomized to receive PNS or placebo for 4 weeks. The placebo group then crossed over and all subjects received PNS for four additional weeks. The primary efficacy endpoint evaluated the proportion of subjects reporting ≥50% pain reduction during weeks 1-4. RESULTS: A significantly greater proportion of subjects receiving PNS (n=7/12, 58%, p=0.037) demonstrated ≥50% reductions in average postamputation pain during weeks 1-4 compared with subjects receiving placebo (n=2/14, 14%). Two subjects were excluded from efficacy analysis due to eligibility changes. Significantly greater proportions of PNS subjects also reported ≥50% reductions in pain (n=8/12, 67%, p=0.014) and pain interference (n=8/10, 80%, p=0.003) after 8 weeks of therapy compared with subjects receiving placebo (pain: n=2/14, 14%; pain interference: n=2/13, 15%). Prospective follow-up is ongoing; four of five PNS subjects who have completed 12-month follow-up to date reported ≥50% pain relief. CONCLUSIONS: This work demonstrates that percutaneous PNS therapy may provide enduring clinically significant pain relief and improve disability in patients with chronic neuropathic postamputation pain. TRIAL REGISTRATION NUMBER: NCT01996254.

Percutaneous 60-day peripheral nerve stimulation implant provides sustained relief of chronic pain following amputation: 12-month follow-up of a randomized, double-blind, placebo-controlled trial.

INTRODUCTION: Peripheral nerve stimulation (PNS) has historically been used to treat chronic pain, but generally requires implantation of a permanent system for sustained relief. A recent study found that a 60-day PNS treatment decreases post-amputation pain, and the current work investigates longer-term outcomes out to 12 months in the same cohort. METHODS: As previously reported, 28 traumatic lower extremity amputees with residual and/or phantom limb pain were randomized to receive 8 weeks of PNS (group 1) or 4 weeks of placebo followed by a crossover 4 weeks of PNS (group 2). Percutaneous leads were implanted under ultrasound guidance targeting the femoral and sciatic nerves. During follow-up, changes in average pain and pain interference were assessed using the Brief Pain Inventory-Short Form and comparing with baseline. RESULTS: Significantly more participants in group 1 reported ≥50% reductions in average weekly pain at 12 months (67%, 6/9) compared with group 2 at the end of the placebo period (0%, 0/14, p=0.001). Similarly, 56% (5/9) of participants in group 1 reported ≥50% reductions in pain interference at 12 months, compared with 2/13 (15%, p=0.074) in group 2 at crossover. Reductions in depression were also statistically significantly greater at 12 months in group 1 compared with group 2 at crossover. CONCLUSIONS: This work suggests that percutaneous PNS delivered over a 60-day period may provide significant carry-over effects including pain relief, potentially avoiding the need for a permanently implanted system while enabling improved function in patients with chronic pain. TRIAL REGISTRATION NUMBER: NCT01996254.