Periarticular Injection Versus Peripheral Nerve Block in Total Hip Arthroplasty: a Single Center Randomized Controlled Trail (RCT) Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Daily Opioid Consumption
研究概览
简要总结
This study will assess if preoperative quadratus lumborum block (QLB)/lateral femoral cutaneous nerve block (LFCNB) with ropivacaine and glucocorticoids provide more effective analgesia than periarticular injection (PAI) with the same mixture in total hip arthroplasty (THA).
详细描述
To support our hypothesis that preoperative quadratus lumborum block (QLB)/lateral femoral cutaneous nerve block (LFCNB) provides more effective analgesia than periarticular injection (PAI) in total hip arthroplasty (THA), we will look at the following outcomes:
Primary outcome: Daily opioid consumption
Secondary outcomes:
Pain intensity and physical functioning while in the hospital: using pain inventory modified from Brief Pain Inventory and Length of hospital stays.
Since both QLB/LFCNB nerve block and PAI techniques are both routinely used as standard of care anesthesia for THA, the study intervention will be the randomization to assign patients to one of these treatment options and assess their response from post-op patient questionnaires and data collection.
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
- Single (Participant)
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
- •Elective unilateral primary THA
- •All surgical approaches
- •American Society of Anesthesiologist (ASA) status I, II and III.
排除标准
- •Patient refusal;
- •Age less than 18 years
- •Those with cognitive dysfunction, psychiatric disorder, or non-English speaking patients that cannot consent or communicate clear understanding of the protocol with research team;
- •Coagulopathy;
研究组 & 干预措施
Group 1 patients will receive nerve block per standard of care
Nerve blocks (QLB/LFCNB) to be placed preoperatively with dexamethasone sodium phosphate (DEX) and methylprednisolone acetate (MPA), per standard of care of anesthesia block service.
- QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA; and
- LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA Preoperatively, Group 1 patients will receive nerve block per standard of care as stated above. Intraoperatively, Group 1 will NOT receive PAI.
干预措施: Nerve Block (Procedure)
Group 1 patients will receive nerve block per standard of care
Nerve blocks (QLB/LFCNB) to be placed preoperatively with dexamethasone sodium phosphate (DEX) and methylprednisolone acetate (MPA), per standard of care of anesthesia block service.
- QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA; and
- LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA Preoperatively, Group 1 patients will receive nerve block per standard of care as stated above. Intraoperatively, Group 1 will NOT receive PAI.
干预措施: Ropivacaine (Drug)
Group 2 will NOT receive any nerve blocks.
Intraoperatively, the surgeon will perform PAI with exactly the same medication as group 1, ie, 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA, per standard of care of Surgeon.
干预措施: Periarticular Injection (PAI) (Procedure)
Group 2 will NOT receive any nerve blocks.
Intraoperatively, the surgeon will perform PAI with exactly the same medication as group 1, ie, 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA, per standard of care of Surgeon.
干预措施: Ropivacaine (Drug)
Group 2 will NOT receive any nerve blocks.
Intraoperatively, the surgeon will perform PAI with exactly the same medication as group 1, ie, 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA, per standard of care of Surgeon.
干预措施: Dex (Drug)
结局指标
主要结局
Daily Opioid Consumption
时间窗: Up to 72 hours
Daily opioid consumption will be monitored during the patient's post surgical hospitalization. Data are presented as milligram morphine equivalent (MME). When the results were entered, the time frame was corrected to reflect the final approved protocol.
次要结局
- Harris Hip Score(2 weeks post operation)
- Change in Pain Intensity While in Hospital(Up to 2 days)
- Length of Stay(Up to 5 days)
- Brief Pain Inventory: Interference(2 weeks post operation)