Lateral Femoral Cutaneous Nerve and Pericapsular Nerve Group (PENG) Blocks Versus Suprainguinal Fascia Iliaca Block in Postoperative Analgesia of Hip Fractures: a Prospective, Controlled, Randomized and Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Dynamic Post-op Hip Pain
研究概览
简要总结
Postoperative pain in hip fractures is challenging and requires adequate management. Peripheral nerve blocks are already known as superior than systemic analgesia in this scenario, but the best analgesic regional technique is still unknown. The investigators propose a study to compare the postoperative analgesia of hip fractures between pericapsular nerve group block plus lateral femoral cutaneous nerve block and suprainguinal fascia iliaca block
详细描述
Postoperative pain in hip fractures is challenging and requires adequate management. In this scenario, peripheral nerve blocks present superior results to systemic analgesia, minimizing the use of opioids and their adverse effects. The lumbar plexus is responsible for the nociception of the hip joint through the femoral, obturator, and accessory obturator nerves, besides being responsible for the sensory innervation of the lateral aspect of the thigh through the lateral femoral cutaneous nerve. Due to this intricate network, several regional techniques have already been proposed. However, the best analgesic approach is still unknown. Ultrasound-guided suprainguinal fascia iliaca block (SIFIB), which addresses the femoral and lateral femoral cutaneous nerves, and ultrasound-guided pericapsular nerve group block (PENG), which addresses terminal branches of the femoral and accessory obturator nerves, are techniques currently used successfully in the context of analgesia for hip surgery. PENG block generates less motor impairment of the quadriceps, which can be significant in terms of mobility and rehabilitation. Both techniques show similar analgesic results in the still scarce literature, but SIFIB has shown slight advantage in some scenarios. However, the PENG block does not reach the lateral cutaneous nerve, which may lead to greater postoperative pain perception. In an attempt to fill this knowledge gap, the investigators propose a study to analyze whether the association between PENG block and lateral femoral cutaneous nerve block (LFCNB) promotes postoperative analgesia equal to SIFIB in a population of adults with hip fractures. This will be a prospective, controlled, randomized, double blind study. Patients with hip fractures (femoral neck, transtrochanteric and subtrochanteric) who will undergo surgical treatment (hip arthroplasty and osteosynthesis with intramedullary nails or screws) will be recruited and randomly allocated into two groups: control (C) and experimental (E). In group C, patients will undergo SIFIB with 30 ml of 0.5% ropivacaine, and to maintain blinding they will also undergo PENG and LFCNB with 20 ml and 10 ml of saline, respectively. In group E, patients will receive the PENG block associated with LFCNB, with 20ml + 10ml of 0.5% ropivacaine, respectively, and 30 ml of saline solution in the SIFIB. After performing the blocks, all patients will undergo spinal anesthesia, with intrathecal injection of 10mg of 0.5% isobaric bupivacaine. As a primary objective, the investigators will evaluate dynamic pain (passive elevation of the leg at 15°) using the Numeric Rating Scale (0-10), 6 hours, 12 hours and 24 hours after spinal anesthesia.
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
In the control group, patients will undergo SIFIB with ropivacaine and to maintain the masking they will also undergo PENG and LFCNB with saline solution (sham block). In the experimental group, patients will receive ropivacaine in the PENG block associated with LFCNB and saline solution in the SIFIB. All the work of randomization, editing of the spreadsheet, manipulation of the envelopes, as well as the confidential tabulation of the data during collection will be done by an assistant who will not participate in the anesthesia or data collection. The opening of the envelopes and the preparation of the material for anesthesia will also be done by an assistant who will not participate in the evaluation of the outcomes. The researcher will perform all the procedures and data collection and will not know which group the participant belongs to. The patient will also not know in which group he or she is allocated.
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 with hip fractures who will undergo surgical treatment.
- •Adults over 18 years.
- •American Society of Anesthesiology physical status 1 to
- •Body mass index (BMI) < 35 Kg/m2.
排除标准
- •Local anesthetic allergy
- •Coagulopathy
- •American Society of Anesthesiology physical status ≥ 4,
- •Peripheral polyneuropathy
- •Pregnancy
- •Chronic opioid use (> 3 months)
- •BMI >35 Kg/m2
- •Stroke with lower limb motor sequelae
- •Patient refusal/withdrawal
- •Those whose spinal anesthesia has been changed to general anesthesia.
研究组 & 干预措施
Suprainguinal Fascia Iliaca Block Group
Patients will undergo SIFIB with ropivacaine and PENG plus LFCNB with saline solution.
干预措施: Ropivacaine + saline solution (Drug)
PENG Block + Lateral Femoral Cutaneous Nerve Block Group
Patients will undergo SIFIB with saline solution and PENG plus LFCNB ropivacaine.
干预措施: Saline solution + Ropivacaine (Drug)
结局指标
主要结局
Dynamic Post-op Hip Pain
时间窗: 24 hours after spinal anesthesia
To assess dynamic hip pain (passive leg elevation at 15°) in postoperative period using the Numeric Rating Scale (0-10), on which patients rate their current pain intensity from (no pain) to 10 (worst possible pain).
次要结局
- Post-op Hip Pain at Rest(6 hours, 12 hours and 24 hours after spinal anesthesia.)
- Quadriceps muscle strength measured by dynamometry in newton (N).(6 hours, 12 hours and 24 hours after spinal anesthesia.)
- Quadriceps muscle strength index(6 hours, 12 hours and 24 hours after spinal anesthesia.)
- Total intravenous morphine dose in milligram over 24 hours(24 hours)
- Time of the first morphine order in minutes(24 hours)
- Incidence of opioid side effects(24 hours)
- Incidence of blockades complications(24 hours)
- Incidence of delirium(24 hours)
研究者
Renato Santiago Gomez
Professor of Surgery Department at Medical School of Universidade Federal de Minas Gerais. Ph.D
Federal University of Minas Gerais
