Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Non-Pharmacologic Alternative for the Treatment of Postoperative Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 12
- 主要终点
- Opioid consumption during first postoperative week
研究概览
简要总结
Postoperative pain is usually treated with opioids that have undesirable and sometimes dangerous side effects (e.g., vomiting and respiratory depression)-and yet over 80% of patients still experience inadequate pain relief. A novel, non-pharmacologic analgesic technique-percutaneous peripheral nerve stimulation (PNS)- holds extraordinary potential to greatly reduce or obviate opioid requirements and concurrently improve analgesia following painful surgery. This technique involves inserting an insulated electric lead adjacent to a target nerve through a needle prior to surgery using ultrasound guidance. Following surgery, a tiny electric current is delivered to the nerve resulting in potent pain control without any cognitive or adverse systemic side effects whatsoever. The electrical pulse generator (stimulator) is so small it is simply affixed to the patient's skin. The leads are already cleared by the US Food and Drug Administration to treat acute (postoperative) pain for up to 60 days; and, since percutaneous PNS may be provided on an outpatient basis, the technique holds the promise of providing potent analgesia outlasting the pain of surgery-in other words, the possibility of a painless, opioid-free recovery following surgery.
The current project is a multicenter, randomized, quadruple-masked, placebo/sham-controlled, parallel-arm pragmatic clinical trial to determine the effects of percutaneous PNS on postoperative analgesia and opioid requirements, as well as physical and emotional functioning, the development of chronic pain, and ongoing quality of life.
详细描述
This is a multicenter, randomized, quadruple-masked, placebo-controlled, parallel-arm pragmatic clinical trial to determine the effects of percutaneous PNS on postoperative analgesia and opioid requirements, as well as physical and emotional functioning, the development of chronic pain, and ongoing quality of life. The primary Specific Aim of the trial is to determine the effect of percutaneous PNS on postoperative opioid requirements and analgesia following moderate-to-severely-painful ambulatory surgery (under the usual conditions in which PNS will be applied, making this a "pragmatic trial"). Secondary Specific Aims are to determine the effect of percutaneous PNS on physical and emotional functioning, chronic pain, and quality of life following moderate-to-severely-painful ambulatory surgery.
Anthropomorphic and demographic characteristics as well as baseline end points will be recorded/measured. Surgical procedures will include rotator cuff repair, ankle arthrodesis, ankle arthroplasty, and hallux valgus correction ("bunionectomy").
Lead implantation. Preoperatively, participants will have a percutaneous lead (MicroLead™, SPR Therapeutics, Inc., Cleveland, OH) inserted to target the brachial plexus (shoulder) or sciatic nerve (foot/ankle) under ultrasound guidance. Patients will be positioned either supine (brachial plexus) or prone (sciatic) and have the lead site prepared with chlorhexidine gluconate/isopropyl alcohol solution and sterile drapes. An ultrasound and linear or curved array transducer within a sterile sleeve will be utilized for lead implantation.
The stimulating probe will be inserted into an introducer "sleeve" and then passed through a lidocaine skin wheal to approximately 2 cm from the epineurium of the target nerve. The probe will be connected to an external pulse generator or "stimulator" (SPRINT® PNS System®, SPR Therapeutics, Inc., Cleveland, OH) with a surface return electrode placed on an ipsilateral limb. Electric current will be delivered at 100 Hz with the intensity slowly increased from zero. The pulse generator intensity setting spans a range of 0 (no current) to 100 (maximum), indicating a combination of amplitude (0-30 mA) and pulse duration (10-133 µs). The optimal sensory changes will target the surgical area; and, if sensory changes occur in a different location or muscle contractions are induced, the stimulator will be switched off, and then the probe/introducer advanced or withdrawn and readvanced with a slightly different trajectory.
This process will be repeated until sensory changes (often described as a "pleasant massage") are perceived in the surgical area. The current will be decreased to zero and the stimulating probe withdrawn from the introducing sleeve, leaving the latter in situ. An introducing needle which is preloaded with the lead will be inserted through the sleeve. The introducing needle-sleeve combination will then be withdrawn, deploying the lead.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older.
- •Undergoing one of the following surgical procedures: rotator cuff repair, ankle arthrodesis or arthroplasty, hallux valgus correction.
- •With a planned single-injection peripheral nerve block for postoperative analgesia.
排除标准
- •Chronic analgesic use including opioids (daily use within the 2 weeks prior to surgery and duration of use > 4 weeks).
- •Neuro-muscular deficit of the target nerve(s).
- •Compromised immune system based on medical history (e.g., immunosuppressive therapies such as chemotherapy, radiation, sepsis, infection), or other conditions that places the subject at increased risk.
- •Implanted spinal cord stimulator, cardiac pacemaker/defibrillator, deep brain stimulator, or other implantable neurostimulator whose stimulus current pathway may overlap.
- •History of bleeding disorder.
- •Antiplatelet or anticoagulation therapies other than aspirin due to the risk of bleeding with a 20-gauge insertion needle.
- •Allergy to skin-contact materials (occlusive dressings, bandages, tape etc.)
- •Incarceration.
- •Chronic pain of greater than 3 months of any severity in an anatomic location other than the surgical extremity.
- •Anxiety disorder.
- •History of substance abuse.
- •Inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access).
研究组 & 干预措施
Peripheral Nerve Stimulation
ACTIVE percutaneous peripheral nerve stimulation with an ultrasound-guided percutaneous lead (SPR Therapeutics, Cleveland, Ohio) and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that generates electrical current
干预措施: Peripheral Nerve Stimulation (Device)
Sham
SHAM percutaneous peripheral nerve stimulation with an ultrasound-guided percutaneous lead (SPR Therapeutics, Cleveland, Ohio) and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that does NOT generate electrical current
干预措施: Sham (Device)
结局指标
主要结局
Opioid consumption during first postoperative week
时间窗: Postoperative days 0-7, collected on days 1, 2, 3, 4 and 7 for the previous 24 hours at each time point.
Cumulative opioid dose following recovery room discharge for days 0-7
Average pain during first postoperative week
时间窗: Postoperative days 0-7, collected on days 1, 2, 3, 4 and 7 for the previous 24 hours at each time point
Mean value of the "average" pain scores following recovery room discharge measured using the numeric rating scale. This is a 0-10 Likert scale measuring pain level with 0=no pain and 10= worst imaginable pain.
次要结局
- Brief pain Inventory, short form (interference subscale)(Collected on postoperative days, 0, 3, 7 and 18; as well as Months 1, 4 and 12.)
- Average pain(Collected on postoperative days 0, 1, 2, 3, 4, 7, 11 and 18; as well as Months 1,4 and 12.)
- Worst/maximum pain(Collected on postoperative days 0, 1, 2, 3, 4, 7, 11 and 18; as well as Months 1, 4 and 12.)
- Opioid consumption(Collected on postoperative days 0, 1, 2, 3, 4, 7, 11 and 18; as well as Months 1,4 and 12.)
- Defense and Veterans Pain Rating Scale(Collected on postoperative days 0, 1, 2, 3, 4, 7, 11 and 18; as well as Months 1, 4 and 12.)
- World Health Organization Quality of life-BREF instrument(Postoperative days, 0 as well as Months 1, 4 and 12.)
- Post-Traumatic Stress Disorder checklist(Postoperative day 0 (baseline))
研究者
Brian M. Ilfeld, MD, MS
Professor of Anesthesiology, In Residence
University of California, San Diego