A Randomized Controlled Study Evaluating Suprainguinal Fascia Iliaca Compartment Block in Direct Anterior Approach to Total Hip Arthroplasty - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Morphine Milligram Equivalent (MME)
研究概览
简要总结
The goal of this study is to determine whether or not a suprainguinal fascia iliaca compartment nerve block is effective at improving postoperative pain control in patients receiving an anterior approach hip replacement surgery. In general, postoperative pain control has a significant impact on earlier ambulation, initiation of physical therapy, better functional recovery, and overall patient satisfaction. The hypothesis is that providing patients with this nerve block will decrease opioid requirements in patients undergoing this surgery as compared to patients that do not receive the block.
详细描述
Study Design: Interventional Trial
Allocation: Randomized
Intervention Model: Parallel Assignment
Treatment groups: Group A: Control Group - DAA THA under spinal anesthesia ( standard of care at Montefiore)
Group B: Intervention Group - DAA THA under spinal anesthesia and a preoperative supra-inguinal fascia iliac compartment block (S-FICB)
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
On the day of surgery, a sealed envelope with group allocation (Group A- Control vs. Group B - Intervention) will be opened by a team member not involved with data collection.
A separate anesthesia team consisting of an anesthesiologist and certified nurse anesthetist will be responsible for the spinal anesthetic and monitored anesthesia care for both groups in the operating room A separate acute pain service team will follow the patients in both groups on postoperative day 1 and evaluate sensory and motor distribution of LFCN, FN, and ON for both groups A research assistant blinded to the allocation of both groups will collect data from the EMR for analysis. In addition, a research assistant blinded to the allocation of both groups will call patients via telephone 24 hours post-discharge for a patient satisfaction survey.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing primary elective total hip arthroplasty under direct anterior surgical approach
- •ASA Class I-III
- •Age > 18 years old
排除标准
- •Patient refusal
- •Inability to understand and sign an informed consent
- •Infection at the injection site
- •Allergy or hypersensitivity to ropivacaine or other amide local anesthetics
- •Contraindication or patient refusal to get spinal anesthesia
- •Thrombocytopenia (Platelets < 100, 000)
- •Coagulopathy (INR > 1.4)
- •Use of anticoagulant drugs that have not been discontinued in an appropriate amount of time - according to American Society of Regional Anesthesia guidelines, prior to surgery
- •End-Stage Renal Disease
- •ASA Class IV-V
- •Patients on chronic opioid therapy on most days for > 3 months [19].
结局指标
主要结局
Morphine Milligram Equivalent (MME)
时间窗: 24 hours postoperatively
Morphine Milligram Equivalent use post-op
次要结局
- Pain scores at 24 hours Postoperatively(24 hours postoperatively)
- Emergency Department Readmissions postoperatively(1-7 days postoperatively)
- Length of Hospital Stay(Up to 7 days)
- Pain scores at 48 hours Postoperatively(48 hours)
- Sensory and Motor Distribution of LFCN, FN and ON(Postoperatively 24 hours after surgery)
- Patient satisfaction of acute postoperative pain management experience(24 hours post discharge)
- Pain scores in PACU(PACU stay)