A Randomized Clinical Trial Comparing the Analgesic Efficacy of Combined Local Anesthetic Blockade and Neuromodulation (Hybrid Technique) Versus Local Anesthetic Blockade Only for Analgesia After Below-knee Amputation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- Pain scores
研究概览
简要总结
This multi-site clinical trial aims to assess the efficacy and safety of combining peripheral nerve stimulation with local anesthetic nerve blockade compared to the standard of care, i.e., local anesthetic blockade only using safe stimulation parameters in a condition associated with high postoperative pain state, i.e. a patient undergoing lower limb amputation.
详细描述
The primary aim of this pilot trial is to evaluate the feasibility, safety, and analgesic efficacy of the hybrid technique (combined PNS and LA-based PNB) compared to that of PNB during the hospital course in patients undergoing below-knee amputations. The secondary aims are to estimate analgesia and opioid-sparing effects at later timepoints of 3, 6, and 12 months following the surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Study team members collecting the data and participating subjects will be blinded to group allocation.
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
- •Patients at least 18 years of age
- •Undergoing below-knee amputation
排除标准
- •Chronic opioid use (daily use within the two weeks before surgery and duration of use of more than four weeks of > 30 mg of oxycodone per day or > 50 of morphine milligrams per day)
- •Neuromuscular deficit of the target nerve(s)
- •Compromised immune system or concurrent risk of infection based on medical history (e.g., immunosuppressive therapies such as chemotherapy, radiation, sepsis, infection).
- •Implanted spinal cord stimulator, cardiac pacemaker/defibrillator, deep brain stimulator, or another implantable neurostimulator whose stimulus current pathway may overlap
- •History of bleeding disorder or chronic antiplatelet or anticoagulation therapies (other than aspirin) that require to be restarted within the first three postoperative days
- •Allergy to study medications or devices (including occlusive dressings, bandages, tape, etc.)
- •Incarceration
- •Pregnancy
- •Chronic pain for more than three months of any severity in an anatomic location other than the surgical site
- •Anxiety disorder
- •History of substance abuse
- •Inability to consent
研究组 & 干预措施
Group Hybrid block
Continuous local anesthetic infusion through the nerve block catheter and peripheral nerve stimulation.
干预措施: Ropivacaine 0.2% + nerve stimulator set (Device)
Group LA block
Continuous local anesthetic infusion through the nerve block catheter.
干预措施: Ropivacaine 0.2% (Drug)
结局指标
主要结局
Pain scores
时间窗: First 24 postoperative hours
Decrease in the proportional incidence of severe or intolerable pain scores (11-point numerical rating scale (NRS) from 0-10, 0 signifying no pain, 10 signifying the worse pain)
次要结局
- Analgesic consumption(At 24, 48, and 72 postoperative hours)
- Quality of recovery (QoR-15)(At postoperative clinic visit (around 1-2 weeks))
- Pain scores(At 12 hour time intervals over the 72 hours)
- Brief Pain Inventory - short form(During the preoperative assessment and at the 3 and 6 months postoperative assessments.)
- Phantom limb pain(At 1 week, three months, 6 months and 1 year)
- Adverse events(Duration of postoperative recovery (typically 1-2 weeks))
- Time to ambulation(Duration of postoperative recovery (typically 1-2 weeks))
- Hospital length of stay(Duration of postoperative recovery (typically 1-2 weeks))
研究者
Chi-Ho Ban Tsui
Professor-Med Ctr Line
Stanford University