Abstract:
BACKGROUND AND OBJECTIVES:Dorsal root ganglion stimulation is an emerging therapy in the treatment of chronic pain. Compared with traditional spinal cord stimulation, it allows a discretely targeted stimulation profile and may act via differing mechanisms of action. Despite these advantages, little is known about the complications associated with this new modality. METHODS:We queried the MAUDE (Manufacturer and User Facility Device Experience) database for all entries named 'Dorsal root ganglion stimulator for pain relief' reported between May 1, 2016 and December 31, 2017. We verified these data through the Office of the Freedom of Information Act at the US Food and Drug Administration. We then eliminated duplicate entries and categorized each complication based on the event description. A secondary analysis was performed to characterize the serious adverse events and the severity of new neurologic symptoms and infections. RESULTS:We identified 979 unique episodes following our process of deduplication. Almost half (47%) of entries were categorized as device-related complications, a quarter (28%) as procedural complications, with the remainder as patient complaints (12%), serious adverse events (2.4%), and 'other' complications (4.6%). The majority of complications were managed surgically with revision (n = 488; 49.8%) rather than explant (n = 161; 16.4%) events, respectively. CONCLUSIONS:The 'Dorsal root ganglion stimulator for pain relief' device has been publicized as a breakthrough in neuromodulation technologies. As with any new technology, we must proceed with caution and re-evaluate effectiveness as information becomes available. The MAUDE database has provided safety data unique for this device that will aid in informed consent and further refinement of this innovative therapy.
journal_name
Reg Anesth Pain Medjournal_title
Regional anesthesia and pain medicineauthors
Sivanesan E,Bicket MC,Cohen SPdoi
10.1136/rapm-2018-000007subject
Has Abstractpub_date
2019-01-01 00:00:00pages
100-106issue
1eissn
1098-7339issn
1532-8651pii
rapm-2018-000007journal_volume
44pub_type
杂志文章abstract::Continuous peripheral nerve blockade has become a popular method of achieving postoperative analgesia for many surgical procedures. The safety and reliability of infusion pumps are dependent on their flow rate accuracy and consistency. Knowledge of pump rate profiles can help physicians determine which infusion pump i...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章
doi:10.1097/AAP.0000000000000130
更新日期:2014-09-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Demand is growing for objective assessment of manual skills and competencies of invasive procedures. The aim of this study was to validate an objective tool for assessing residents' skill in performing epidural anesthesia by use of a global assessment scale and a 3-scale, 27-stage checklist. W...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章
doi:10.1016/j.rapm.2006.04.006
更新日期:2006-07-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:The typical blind insertion of a catheter into the epidural space risks catheter misplacement into the intrathecal space. The epidural stimulation test is designed to confirm the correct epidural location of a catheter but may also detect unintended intrathecal catheter placement by evaluating...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章
doi:10.1097/aap.0b013e3181bfbe1e
更新日期:2009-11-01 00:00:00
abstract:BACKGROUND:We report the first prospective sonoanatomic study in neonates with the aim to perform ultrasonographic-guided epidural catheter placement in this age group. METHOD:One hundred forty-five neonates with a body weight < or =4 kg (0.53-4 kg) were included in this prospective study. The study was divided into 3...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章
doi:10.1016/j.rapm.2006.10.008
更新日期:2007-01-01 00:00:00
abstract:UNLABELLED:Neurologic injury after regional anesthesia or pain medicine procedures is rare. Postprocedural neurologic deficits may create high levels of anxiety for the patient and practitioner, although most deficits are limited in severity and can be expected to fully resolve with time. Postoperative anesthesia-relat...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章,评审
doi:10.1097/AAP.0000000000000185
更新日期:2015-09-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Ischemic preconditioning of tissue that is to undergo procedure-induced underperfusion has been used in a number of surgical settings to reduce the subsequent inflammatory response and its sequelae. The objective of this prospective, randomized study was to evaluate the effect of ischemic prec...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章,随机对照试验
doi:10.1097/aap.0b013e3181e82e8e
更新日期:2010-09-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:This prospective randomized trial compared ultrasound-guided single-injection (SI) and triple-injection (TI) subparaneural popliteal sciatic nerve block. We hypothesized that multiple injections are not required when local anesthetic (LA) is deposited under the paraneurium because the latter e...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1097/AAP.0000000000000253
更新日期:2015-07-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:The aim of the study was to examine the analgesic effects of the anticonvulsant, gabapentin, in a validated model of acute inflammatory pain. METHODS:Twenty-two volunteers were investigated in a double-blind, randomized, placebo-controlled cross-over study. Gabapentin 1,200 mg or placebo was ...
journal_title:Regional anesthesia and pain medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1053/rapm.2001.25070
更新日期:2001-07-01 00:00:00
abstract:OBJECTIVE:Sacroiliac joint injections are frequently performed procedures in the management of acute and chronic low-back pain, including patients with various immunocompromised states. Infectious complications following these procedures along with other spinal injections are rarely reported, but the true incidence is ...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章
doi:10.1097/AAP.0000000000000608
更新日期:2017-07-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:The aim of this study was to investigate the possible local neurotoxicity of a number of lipid-depot formulations of local anesthetics in relation to their duration of action in sciatic-nerve block. METHODS:Formulations that contain 2%, 4%, 8%, 16%, 32%, or 64% of a mixture of bupivacaine and...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章
doi:10.1016/j.rapm.2006.05.008
更新日期:2006-09-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Anesthesiologists are increasingly utilizing the Internet for personal and professional purposes. Without guidance, the task of searching the Internet for information may be time-consuming and frustrating. This article includes a basic introduction to the Internet with suggestions and guidelin...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章,评审
doi:10.1016/s1098-7339(99)90115-3
更新日期:1999-07-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Several types of quadratus lumborum block (QLB) are used for postoperative analgesia and are believed to be effective against both somatic and visceral pain via a local anesthetic (LA) effect in the paravertebral space (PVS). However, it remains unclear whether all QLB techniques result in LA ...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章
doi:10.1097/AAP.0000000000000735
更新日期:2018-05-01 00:00:00
abstract:BACKGROUND:Given the steep learning curve for neuraxial and peripheral nerve blocks, utilization of general anesthesia may increase as new house staff begin their residency programs. We sought to determine whether "July effect" affects the utilization of neuraxial anesthesia, peripheral nerve blocks, and opioid prescri...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章
doi:10.1136/rapm-2020-101318
更新日期:2020-05-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Epidural anesthesia is a technically challenging regional anesthetic technique that can be difficult to teach to novices. Epidural simulators are now available to allow realistic training within a safe and controlled environment before attempting the procedure on patients. Potentially, this ma...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章,随机对照试验
doi:10.1097/AAP.0b013e3181a34345
更新日期:2009-05-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:For pain relief after total knee arthroplasty (TKA), an injection at the midthigh level may produce analgesia inferior to that of a femoral nerve block as the anterior femoral cutaneous nerves (intermediate femoral cutaneous nerve (IFCN) and medial femoral cutaneous nerve (MFCN)) are not anest...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章
doi:10.1136/rapm-2019-100904
更新日期:2019-12-10 00:00:00
abstract:BACKGROUND:Approximately 15% of patients report persistent knee pain despite surgical success following total knee arthroplasty (TKA). The purpose of this study was to determine the association of acute-postsurgical pain (APSP) with chronic postsurgical pain (CPSP) 6 months after TKA controlling for patient, surgical a...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章
doi:10.1136/rapm-2018-100036
更新日期:2019-02-15 00:00:00
abstract:BACKGROUND AND OBJECTIVES:We tested the hypothesis that an opioid-free local anesthetic alone is able to provide comparable analgesia to the opioid supplemented epidural application of local anesthetics using thoracic epidural catheters after major abdominal surgery. METHODS:In a prospective, randomized, and double-bl...
journal_title:Regional anesthesia and pain medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1053/rapm.2002.32583
更新日期:2002-07-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Glomangiomas are rare, vascular tumors consisting of an afferent artery, arteriovenous canal, neuro-reticular elements, collagen, and efferent veins, and are most often located in the soft tissue of the upper extremities. We describe how the use of ultrasound-guided nerve blockade altered the ...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章
doi:10.1016/j.rapm.2007.10.003
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Perioperative systemic lidocaine provides postoperative analgesia, decreases opioid consumption, and facilitates rehabilitation in abdominal surgery. We hypothesized that systemic lidocaine has analgesic effects in women undergoing day-case laparoscopic sterilization. METHODS:Eighty women wer...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章,随机对照试验
doi:10.1097/AAP.0000000000000398
更新日期:2016-05-01 00:00:00
abstract:BACKGROUND:Ultrasound (US) guidance, in some instances, can increase the success rate and reduce the onset and procedure times for peripheral nerve blockade compared with traditional nerve localization techniques. The presumptive mechanism for these benefits is the ability to accurately inject local anesthetic circumfe...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章,随机对照试验
doi:10.1097/AAP.0b013e318217a6a1
更新日期:2011-05-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Concern for block-related injury and liability has dissuaded many anesthesiologists from using regional anesthesia for eye and extremity surgery, despite many studies demonstrating the benefits of regional over general anesthesia. To determine injury patterns and liability associated with eye ...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章,多中心研究
doi:10.1016/j.rapm.2008.01.016
更新日期:2008-09-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:The study goal was to compare the effect of epinephrine in different doses on pulmonary gas exchange in a rat model of bupivacaine-induced cardiac depression. METHODS:Twenty-four adult male Sprague-Dawley rats were divided into 4 groups (n = 6), and each group received a bupivacaine infusion (...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章
doi:10.1097/AAP.0000000000000541
更新日期:2017-05-01 00:00:00
abstract:BACKGROUND:Subarachnoid blocks are considered routine anesthetic procedures important in the daily practices of most anesthesiologists. However, few data exist regarding modern failure rates or quality-compromising behaviors. METHODS:Sixty adult patients having orthopedic surgery under spinal anesthesia were enrolled ...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章
doi:10.1097/AAP.0b013e3182030863
更新日期:2011-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:0.1% bupivacaine for obstetric epidural analgesia is given by infusion, using a loading dose of a higher concentration alone or in combination with opioid analgesics. A single dose of 0.1% without any additive for relief of first-stage labor pain has not yet been documented. METHODS:Fifty-eig...
journal_title:Regional anesthesia and pain medicine
pub_type: 临床试验,杂志文章
doi:10.1097/00115550-199823020-00004
更新日期:1998-03-01 00:00:00
abstract::The introduction of ultrasound guidance for regional anesthesia has resulted in an explosion of interest in its use for postoperative analgesia, particularly for orthopedic surgery. Regional anesthesia demonstrates unequivocal superiority compared with systemic opioids with respect to analgesia, reduced opioid consump...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章
doi:10.1097/AAP.0b013e318295d973
更新日期:2013-07-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Local anesthetics in blood absorbed from the epidural space attenuate bronchial hyperreactivity to chemical stimuli. However, it is not documented whether local anesthetics at clinically relevant concentrations improve active wheezing in patients with bronchial asthma. CASE REPORT:We managed ...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章
doi:10.1016/s1098-7339(99)90015-9
更新日期:1999-09-01 00:00:00
abstract::Abrupt cessation of intrathecal baclofen (ITB) administration can cause a life-threatening withdrawal syndrome that requires prompt diagnosis and urgent treatment. The current therapy for this condition is administration of propofol, benzodiazepines, paralytics and supportive care. This study reports a 53-year-old pat...
journal_title:Regional anesthesia and pain medicine
pub_type: 杂志文章
doi:10.1097/AAP.0b013e3181b4cc6b
更新日期:2009-11-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:This study examined whether perioperative multimodal analgesia (MMA) improves the effectiveness of intravenous nutrition (IVN) as a means of preventing protein wasting following major upper abdominal surgery (UAS). The MMA regimen utilized combined epidural opioid/local anesthetic and the syst...
journal_title:Regional anesthesia and pain medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1053/rapm.2002.27850
更新日期:2002-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:The aim of this study was to determine whether an intrabursal morphine and bupivacaine mixed infusion provides useful analgesia for prolonged pain relief after subacromial arthroscopic operation. METHODS:A continuous intrabursal infusion catheter was inserted at the conclusion of the subacrom...
journal_title:Regional anesthesia and pain medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1053/rapm.2002.31209
更新日期:2002-03-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:The interscalene brachial plexus block (ISB) is an effective and well-established anesthetic technique for shoulder surgery. Using nerve stimulation as an aid in block placement, a motor response (twitch) in the biceps or a more distal upper limb muscle has been recommended to indicate accurat...
journal_title:Regional anesthesia and pain medicine
pub_type: 临床试验,杂志文章
doi:10.1053/rapm.2000.7597
更新日期:2000-07-01 00:00:00