Genicular Nerve Block for Analgesia After Open Reduction Internal Fixation of Tibial Plateau Fractures: A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Pain Ratings from Visual Analog Scale (VAS)
研究概览
简要总结
The investigators are conducting this research study to find better ways of treating pain following knee surgery. There is a standard (accepted) approach, which involves injection of numbing medication into the area around the participant surgical incision. The investigators hope to discover if providing numbing medication to a nerve that controls pain in a larger area of the knee (a nerve block), might be better at post-operative pain control.
详细描述
The investigators are conducting this research study to find better ways of treating pain following knee surgery like the one the participant will be having. There is a standard (accepted) approach, which involves injection of numbing medication into the area around the participant surgical incision. The investigators hope to discover if providing numbing medication to a nerve that controls pain in a larger area of the knee (a nerve block), might be better at post-operative pain control. This type of nerve block is commonly used to treat other knee pains, like that associated with arthritis, after knee replacements, and after repairs of the knee ligaments; however, it is considered experimental in your case, as its effects (good or bad) are unknown in the type of knee surgery the participant are undergoing.
The investigators plan is to decide at random, like the flip of a coin, whether to give numbing medication (0.25% bupivacaine) around the incision like the investigators normally would or give it instead to block the pain sensors around the knee. The participant would get medication either at the incision (shin) or the knee, depending on which arm the participant are in (research). The participant will also be given pain medication pills by your surgeon as part of the participant normal postoperative care (not research).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The envelope will be opened in the operating room prior to beginning the procedure. This ensures subjects are blinded to their treatment modality.
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
- •Any adult patient (ages 18 and over) undergoing open reduction internal fixation of an acute isolated tibial plateau fracture
排除标准
- •Subjects younger than 18
- •Polytraumatized Subjects
- •Subjects with pathologic fractures
- •Subjects with tibial plateau fractures treated nonoperatively
- •Subjects with tibial plateau fractures treated operatively but with re-operations at the same site
- •Subjects with open fractures
- •Subjects with fracture-dislocations
- •Subjects with active or history of anxiety
- •Subjects with visual analog scale anxiety score ≥ 7 measured preoperatively
- •Subjects with chronic pain syndromes
- •Subjects with chronic opioid use
- •Subjects with illicit drug use disorder
- •Subjects with alcohol abuse disorder
- •Subjects with kidney disease precluding use of ketorolac
- •Subjects with liver disease precluding the use of acetaminophen
- •Subjects with allergy to acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), opiates or local anesthesia
- •Subjects with inability to provide a visual analog scale score postoperatively
- •Subjects with contraindications to receiving peripheral nerve blocks, including relevant neurologic deficits, active infection at sites of injections - re-operation at the same site
研究组 & 干预措施
Genicular nerve blockade
Subjects randomized to genicular nerve block will receive a fluoroscopic guided injection of 5 ml of 0.25% bupivacaine at the described locations of the superolateral genicular nerve, super medial genicular nerve, inferomedial genicular nerve, recurrent fibular nerve, and infrapatellar branch of the saphenous nerve under fluoroscopic guidance at the time of wound closure
干预措施: Bupivacain (Drug)
Peri-incisional local anesthesia
subjects randomized to peri-incisional local anesthesia administration will receive an injection of 25 ml of 0.25% bupivacaine across all incisions at the time of wound closure (standard of care)
结局指标
主要结局
Pain Ratings from Visual Analog Scale (VAS)
时间窗: one hour, two hours, and discharge from PACU
To determine if genicular nerve blockade after open reduction internal fixation of tibial plateau fractures compared to standard care of peri-incisional local anesthetic leads to decreased pain as measured by visual analog scale at one hour postoperatively, two hours postoperatively, and at Post Anesthesia Care Unit (PACU) discharge. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
次要结局
- Comparing blocks(2 weeks after surgery)
- Block effect on range of motion(PACU discharge)
- VAS score daily first three days after surgery(daily for three days after surgery)
- Brief pain inventory (short scale) daily first three days after surgery(daily first three days after surgery)
- effect of genicular nerve blockade compared to standard peri-incisional local anesthetic(2 weeks post surgery)
- Comparing blocks(one hour after surgery, 2 hours after surgery, and discharge from PACU)
- Comparing blocks(daily first three days after surgery)