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临床试验/NCT04860856
NCT04860856已完成4 期

Efficacy of Hematoma Block on Postoperative Pain After Femoral Intramedullary Rodding: A Randomized Trial

University of Cincinnati1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2019年8月17日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
88
试验地点
1
主要终点
Change in postoperative pain at 72 hours

研究概览

简要总结

The purpose of this study is to evaluate the efficacy of an intra-operative, post-fixation fracture hematoma block compared to saline control on postoperative pain control in patients with acute femoral shaft fractures. Our primary outcome measure is visual analog scale (VAS) pain scores which are recorded at regular intervals.

详细描述

This blinded, randomized control trial is being performed at the University of Cincinnati Medical Center.

Patients will be randomly assigned to one of two treatment groups: Group One will be comprised of patients treated with fracture site injection containing 20 mL of 0.5% ropivacaine with an 18-gauge needle (150 mm length), Group Two will be comprised of patients treated with fracture site injection containing 20ml of normal saline. The injection will be administered by the orthopaedic trauma team after the insertion of the final intramedullary implant and skin closure prior to final surgical dressing application. The injection will be performed in a standard fashion with aspiration of hematoma followed by the injection. All postoperative management will be per standard of care.

The size of the hematoma will have no effect on the procedure. When a hematoma block is utilized in the care of orthopaedic trauma patients, its aim is to infiltrate the anesthetic to the fracture edges and injured soft tissue to allow for pain control and fracture manipulation without additional sedation. Aspiration of the hematoma tells the clinician that the tip of the needle is near the fracture site and not in a neurovascular structure.

The maximal single dose of ropivacaine without vasoconstrictor is 2-3 mg/kg.9 0.5% ropivacaine has 5 mg/mL of ropivacaine. 20 mL of 0.5% ropivacaine has 100 mg of ropivacaine. 100 mg of ropivacaine can be toxic to a patient less than 33-50 kg or 73-110 lb. If a patient weighs less than 110 lb, the ropivacaine dose will be scaled down below 2 mg/kg.

Regional anesthesia including nerve blocks is not routinely used in the setting of traumatic femoral shaft fractures. A nerve block would compromise the patient's neurologic examination in the immediate postoperative period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Care Provider)

盲法说明

The patients and the nursing staff who assess postoperative pain will be blinded to the treatment 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

入选标准

  • Trauma patient at the University of Cincinnati Medical Center
  • Skeletally mature patients
  • Have an isolated, closed, acute traumatic femoral shaft fracture to be treated with a closed reduction and reamed intramedullary rod fixation

排除标准

  • Unable to provide informed consent
  • Member of a vulnerable patient population
  • Have additional injuries
  • Have a history of prior existing narcotic use or chronic pain management issues on presentation

研究组 & 干预措施

Hematoma block

Experimental

Fracture site injection of 20 mL of 0.5% ropivacaine with an 18-gauge needle (150 mm length).

干预措施: 0.5% ropivacaine (Drug)

Normal saline injection

Placebo Comparator

Fracture site injection of 20ml of normal saline.

干预措施: Normal Saline (Drug)

结局指标

主要结局

Change in postoperative pain at 72 hours

时间窗: Measured at 0, 8, 16, 24, 36, 48, and 72 hours postoperatively

Postoperative pain will be assessed using a visual analog scale

次要结局

  • Narcotic usage(Narcotic usage will be assessed through 72 hours postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruixian Yue

Principal Investigator

University of Cincinnati

研究点 (1)

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