Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge
研究概览
简要总结
The purpose of this study is to determine whether the use of a lumbar plexus block for arthroscopic hip surgery is superior to oral and intravenous opioid pain medications alone in treating pain. In addition, the study will examine whether lumbar plexus blocks reduce the total amount of pain medication needed, and therefore reduce the side effects of these medicines and increase patient satisfaction. It is hypothesized that addition of the lumbar plexus block will significantly reduce patients' postoperative pain.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) Class 1-3
- •Patients aged 18 to 65 years
- •Patients scheduled for primary, unilateral arthroscopic hip surgery by Dr. Kelly, Dr. Coleman, or Dr. Anil Ranawat
- •Planned use of neuraxial anesthesia
- •Body Mass Index less than 35
- •Ability to follow study protocol
排除标准
- •Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
- •Contraindication to combined spinal-epidural anesthesia including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.
- •Contraindication to lumbar plexus block including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.
- •Infection at the injection site(s)
- •Allergy to any of the study medications
- •Contraindication to a short course of NSAIDs (renal failure, intolerance)
- •ASA Class 4-5
- •Patient refusal
- •Patients younger than 18 years old and older than 65
- •Patients with any known indwelling hardware of the lumbar spine.
- •Patients with a peripheral neuropathy of the surgical extremity
- •Non-English speaking patients
结局指标
主要结局
Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge
时间窗: Day of surgery prior to discharge
The Numeric Rating Scale was used to ask patients to rate their pain at rest on a scale of 0 to 10, 0 = no pain and 10 = worst pain imaginable.
次要结局
- Readiness to Discharge From Post-Anesthesia Care Unit (PACU)(Day of surgery prior to discharge)
- Narcotic Pain Medication Needed(Day of surgery prior to discharge)
- Incidence of Nausea(Day of surgery prior to discharge)
- Incidence of Vomiting(Day of surgery prior to discharge)
- Requirement of Antiemetic Rescue(Day of surgery prior to discharge)
- Patient Satisfaction(First 24 hours after surgery)
- Quality of Recovery (QoR-40) Physical Comfort Dimension(First 24 hours after surgery)