Femoral Rami Obturator Nerve Trunk (FRONT) Block in Intramedullary Nail Surgery .
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Time to first postoperative analgesic request
研究概览
简要总结
The study propose that using femoral rami obturator nerve trunk(FRONT) block may help postoperative analgesia in nail femur surgeries. The technique is relatively new, introducing one needle to target two nerve blocks in the same entry point. The block spare motor fibers of femoral nerve so it may help both early mobilization and effective analgesia, which in turn enhance early recovery and better outcomes.
详细描述
Post operative pain levels after hip fracture are high during ambulation and may worsen outcome after hip fracture. Regional anesthesia has shown to facilitate rehabilitation in orthopedics procedures. Many of these regional anesthesia techniques ,such as femoral nerve, lumber plexus, peri capsular nerve group(PENG), fascia iliaca blocks have gained attention for their opioid and some times for motor sparing potential, as well as the ability to provide targeted analgesia for anterior hip joint. Nevertheless the anterior hip joint coverage needs the constant contribution of femoral and obturator nerves to provide adequate pain relieve. In this study patients will receive preoperative femoral rami obturator nerve trunk(FRONT) block , a novel regional anesthesia technique described by Jessen et al., as a promising solution to the long-standing challenge of anesthetizing both the femoral and obturator nerve branches in anterior hip joint for postoperative pain control, addressing a more comprehensive coverage of anterior hip innervation.
Note: The protocol was amended prior to enrollment of the reported cohort. The control group was changed from multimodal analgesia alone to a sham block procedure; the primary outcome was changed from postoperative NRS pain score to time to first analgesic request; motor assessment was changed from the Modified Bromage scale to Manual Muscle Testing (MRC scale) and straight leg raise, the Modified Bromage scale being discontinued; and the upper limit of ASA physical status was extended from II to III.
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)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the elderly age≥60 years
- •American Society of Anesthesiologists (ASA) classification I, II, III
- •patients who undergoing surgery for intramedullary nail surgery.
排除标准
- •patient refused to participate and consent
- •patients with a history of mild cognitive impairment (MCI), dementia, and delirium
- •patients with known preoperative infections (pulmonary infection, urinary infection, and sepsis).
- •coagulopathy
研究组 & 干预措施
Control group
Sham Control: Patients underwent an identical ultrasound-guided needle insertion procedure at the same anatomical sites (iliopsoas plane and subpectineal compartment) with injection of an equivalent volume of placebo drug in the form of normal salin. All patients, including the sham group, received the same standardized multimodal systemic analgesic regimen (paracetamol 1g/6h and ketorolac 30 mg /8h routinely plus nalbuphine 6 mg IV bolus as rescue analgesia when needed for NRS ≥ 4)
干预措施: Sham block (Procedure)
FRONT Block
FRONT Block: Patients received an ultrasound-guided femoral rami and obturator nerve trunk (FRONT) block, performed in the operating room prior to spinal anesthesia with the patient supine. Using an in-plane technique with a 22-gauge echogenic needle through a single entry point, 20 mL of 0.125% plain levobupivacaine was deposited in the iliopsoas plane and 20 mL in the subpectineal compartment. Electrical nerve stimulation (0.4 mA, 0.1 ms pulse duration) was used to confirm needle placement and exclude direct femoral motor nerve involvement prior to injection. Sensory block was checked by pinprick before proceeding to spinal anesthesia as routine clinical practice; these findings were not systematically recorded. All patients, including the FRONT group, received the same standardized multimodal systemic analgesic regimen (paracetamol 1g/6h and ketorolac 30 mg /8h routinely plus nalbuphine 6 mg IV bolus as rescue analgesia when needed for NRS ≥ 4)
干预措施: Femoral rami obturator nerve trunk (FRONT) block (Procedure)
结局指标
主要结局
Time to first postoperative analgesic request
时间窗: [Time Frame: up to 36 hours postoperatively]
Description: Time in hours when the first patient request for rescue analgesia (IV nalbuphine 6 mg iv bolus)
Postoperative analgesia
时间窗: Patients will be followed for 36 hours postspinal and assessed for pain, at 2, 4, 6, 12, 18, 24, 36 hours
Pain level will be assessed after spinal anesthesia is resolved using rest/dynamic numeric rating scale (NRS) with patients rating their pain on a scale from 0 to 10. On this scale, 0 means "no pain" and 10 means "the worst pain imaginable"
次要结局
- Modified Bromage score(Patients will be followed for 36 hours postoperatively and assessed for motor function at 2, 4, 6, 12, 18, 24, 36 hours.)
- Numeric Rating Scale (NRS)(Time Frame: 2, 4, 6, 12, 18, 24, 36 hours postoperatively])
- Manual Muscle Testing (MRC scale)(Time Frame: 2, 4, 6, 12, 18, 24, 36 hours postoperatively)
- Straight Leg Raise (SLR) test([Time Frame: 2, 4, 6, 12, 18, 24, 36 hours postoperatively])
- Opioid consumption(When 36 hours postoperatively has passed.)
- Motor function(Patients will be followed for 36 hours postoperatively and assessed for motor function at 2, 4, 6, 12, 18, 24, 36 hours.)
- Complication(Patients will be followed for 36 hours postoperatively and assessed for presence of any complications or side effects at 2, 4, 6, 12, 18, 24, 36 hours)
研究者
Mohamed Gaber Ahmed
lecturer in anesthesia, Intensive Care and Pain Management
South Valley University