TMS in the Management of Postoperative Pain

TMS 在术后疼痛管理中的应用

• 批准号: 7888340
• 负责人: Jeffrey J Borckardt
• 金额: $ 21.9万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-06-25 至 2011-07-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7888340
• 关键词: Abdomen; Absence of pain sensation; Acute; Acute Pain; Adult; Adverse effects; Affective; Anxiety; Area; Brain; Chronic; Clinical; Conscious; Constipation; Coughing; Data; Dimensions; Dose; Double-Blind Method; Effectiveness; Funding; Future; Health Care Costs; Healthcare; Hour; Human Resources; Implant; Implanted Electrodes; Inpatients; Intervention; Intractable Pain; Investigation; Knowledge; Lead; Left; Length of Stay; Life; Masks; Mental Depression; Methodology; Monitor; Moods; Morphine; Narcotics; Nausea and Vomiting; Neuroanatomy; Neurosciences; Nociception; Obstructive Sleep Apnea; Operative Surgical Procedures; Opiates; Opioid; Outcome; Pain; Pain management; Participant; Patient-Controlled Analgesia; Patients; Perception; Pharmaceutical Preparations; Postoperative Pain; Postoperative Period; Prefrontal Cortex; Psyche structure; Pulmonary Hypertension; Quality of life; Randomized; Recovery; Recovery Room; Reliance; Research; Right Ventricular Dysfunction; Risk; Rofecoxib; Sedation procedure; System; Techniques; Testing; Time; Transcranial magnetic stimulation; Ventilatory Depression; Visual; Vomiting; War; Work; addiction; alertness; analog; bariatric surgery; chronic pain; clinical application; cost; design; experience; follow up assessment; follow-up; implantation; innovation; interest; medical complication; patient population; public health relevance; repetitive transcranial magnetic stimulation; research and development; respiratory

DESCRIPTION (provided by applicant): The proper control of acute and chronic pain is one of the most important areas of health care. Despite profound advances in neuroscience, opiate narcotics are heavily relied upon for postoperative pain control. This is problematic as opiates can sometimes lead to addiction and are associated with considerable side effects that are especially problematic in patients recovering from abdominal surgery, as they can directly hinder gut recovery, likely prolong hospital stay and delay recovery. Presently, there do not appear to be good replacement pharmacological candidates for postoperative pain control. Brain stimulation for pain control is an exciting new area that builds on advancing neuroscience knowledge concerning the functional neuroanatomy of pain. Cortical stimulation can now be performed non-invasively by transcranial magnetic stimulation (TMS). Several studies have shown that TMS can reduce pain in healthy adults and patients with chronic pain. Recently, it was shown that a single 20-minute treatment of TMS over the left-prefrontal cortex (an area that is likely involved in inhibiting the affective dimension of pain) significantly reduced postoperative pain and patient-controlled analgesia (PCA) use by 37% among 40 patients immediately following gastric- bypass surgery. However, methodological concerns surrounding these preliminary findings limit definitive conclusions about the effectiveness of TMS in controlling post-operative pain. This R21 proposal will integrate more rigorous experimental conditions, a true double-masked methodology, and longer-term follow- up assessment. The data from this R21 will provide the information needed for launching a definitive larger- scale investigation into potential clinical applications and mechanisms of action of TMS in controlling post- operative pain. Using rigorous double-masked methods and building on preliminary pilot work, we propose (Aim1) to test whether repetitive transcranial magnetic stimulation over the left prefrontal cortex significantly reduces post-operative pain and PCA use following gastric-bypass surgery. We also propose (Aim2) to determine the effects of timing and dose of TMS on post-operative pain and PCA use. Lastly, (Aim3) we propose to determine the effects of TMS on post-surgical recovery time, clinical outcomes and healthcare costs at 1-month, 3-months and 6-months follow-up. 132 participants will be randomly assigned to receive 20 minutes of: active prefrontal TMS or sham prefrontal TMS 45-minutes after gastric-bypass surgery. Participants will then be re-randomized to receive a second treatment (either real or sham) 8 hours later. Participants' PCA usage will be tracked along with twice-daily visual analogue scale ratings of postoperative pain and mood. This design provides 4 conditions yielding information relevant to the effects of timing and dose of TMS on postoperative pain control and longer-term clinical outcomes. Results from this pilot will likely supply substantial information about the utility of cortical stimulation for pain postoperative control. PUBLIC HEALTH RELEVANCE: The proper control of acute and chronic pain is one of the most important areas of health care, and despite profound advances in neuroscience, opiate narcotics are heavily relied upon for postoperative pain control. There are many risks associated with opiate use including respiratory depression, nausea and vomiting, cough suppression, mental clouding, sedation and constipation, and many of these side-effects are particularly problematic in gastric-bypass surgery patients who tend to have respiratory problems (like obstructive sleep apnea), right ventricular dysfunction, pulmonary hypertension, and for whom post-operative vomiting could result in serious complications. Thus, new interventions that have the potential to reduce reliance on postoperative morphine in this patient population such as TMS need to be explored.

描述（由申请人提供）：急性和慢性疼痛的适当控制是医疗保健最重要的领域之一。尽管在神经科学方面取得了深刻的进展，但阿片类麻醉剂仍严重依赖于术后疼痛控制。这是一个问题，因为阿片类药物有时会导致成瘾，并且会产生相当大的副作用，这对于从腹部手术中恢复的患者来说尤其成问题，因为它们会直接阻碍肠道恢复，可能会延长住院时间并延迟康复。目前，似乎没有很好的替代药物候选人术后疼痛控制。用于疼痛控制的脑刺激是一个令人兴奋的新领域，它建立在关于疼痛的功能性神经解剖学的先进神经科学知识的基础上。皮质刺激现在可以通过经颅磁刺激（TMS）非侵入性地进行。一些研究表明，TMS可以减轻健康成人和慢性疼痛患者的疼痛。最近，研究表明，在胃旁路手术后立即对40名患者的左前额叶皮层（可能参与抑制疼痛情感维度的区域）进行单次20分钟TMS治疗，可显著减少术后疼痛和患者自控镇痛（PCA）使用37%。然而，围绕这些初步研究结果的方法学问题限制了关于TMS控制术后疼痛有效性的明确结论。该R21提案将整合更严格的实验条件、真正的双盲方法和长期随访评估。来自该R21的数据将提供启动对TMS在控制术后疼痛中的潜在临床应用和作用机制的确定性更大规模研究所需的信息。使用严格的双盲方法和初步试点工作的基础上，我们建议（目标1），以测试是否重复经颅磁刺激左前额叶皮层显着减少术后疼痛和PCA使用胃旁路手术后。我们还建议（目标2）确定TMS的时间和剂量对术后疼痛和PCA使用的影响。最后，（目标3）我们建议在1个月、3个月和6个月随访时确定TMS对术后恢复时间、临床结局和医疗费用的影响。132名受试者将被随机分配接受20分钟的活动前额叶TMS或假前额叶TMS-胃旁路手术后45分钟。然后，受试者将在8小时后重新随机接受第二次治疗（真实的或假治疗）。将沿着每天两次的术后疼痛和情绪视觉模拟量表评分，跟踪参与者的PCA使用情况。该设计提供了4种条件，产生与TMS的时间和剂量对术后疼痛控制和长期临床结局的影响相关的信息。该试验的结果可能会提供关于皮层刺激用于术后疼痛控制的实用性的大量信息。公共卫生相关性：急性和慢性疼痛的适当控制是医疗保健的最重要领域之一，尽管神经科学取得了深刻的进步，但阿片类麻醉剂在术后疼痛控制中仍严重依赖。有许多风险与阿片类药物的使用，包括呼吸抑制，恶心和呕吐，咳嗽抑制，精神模糊，镇静和便秘，其中许多副作用是特别有问题的胃旁路手术患者往往有呼吸问题（如阻塞性睡眠呼吸暂停），右心室功能障碍，肺动脉高压，并为他们术后呕吐可能导致严重的并发症。因此，需要探索新的干预措施，有可能减少对术后吗啡的依赖，如TMS。