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临床试验/NCT04114058
NCT04114058已完成4 期

Pain Outcomes Following Hip Arthroscopy: A Prospective Randomized Control Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2019年10月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
37
试验地点
1
主要终点
Visual Analogue Scale

研究概览

简要总结

The purpose of this study is to compare the effectiveness of fascia iliaca blockade vs local field infiltration with liposomal bupivicaine in controlling pain, narcotic utilization and falls in the postoperative period following hip arthroscopy

详细描述

The purpose the research is to help determine optimal means of post-operative analgesia following hip arthroscopic procedures. Post-operative pain is a significant contributor to patient satisfaction and the side effects of narcotic pain medication are well described. The ideal intervention for achieving appropriate analgesia following hip arthroscopy has not yet been defined. Determining means of achieving acceptable post-operative pain relief while minimizing narcotic usage will help yield maximal patient outcomes.The primary research procedures entailed in this study include fascia iliaca nerve blockade with Marcaine and local field infiltration with liposomal bupivicane (Exparel). The patients in this study will include those who have both a clinical and radiographic diagnosis of femoracetabular impingement (FAI), have failed non operative treatment, and are indicated for hip arthroscopy with labral repair and femoroplasty/acetabuloplasty. The study includes the surgical procedure and the first post-operative follow up visit. The total study duration is approximately 1.5 weeks for each patient. The study will be carried out until the patients first post-operative visit which typically occurs 7-10 days after the procedure. We are to include approximately 40 patients in total for this study over a period of 4 months.

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
None

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

  • adult patients (>18 years old)
  • diagnosed FAI that are indicated for hip arthroscopic labral repair and femoroplasty/acetabuloplasty.

排除标准

  • patients undergoing revision procedures, bilateral procedures,
  • advanced osteoarthritis (<2mm joint space on plain radiographs)
  • frank dysplasia (anterior and/or lateral center edge angles <20 degrees and/or Tonnis angle >15 degrees)
  • diagnoses other than FAI (Legg Calve Perthes, femoral head avascular necrosis, septic arthritis, or post traumatic deformity).
  • allergy to liposomal bupivicaine

研究组 & 干预措施

Liposomal Bupivicaine

Active Comparator

Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control

干预措施: liposomal bupivicaine (Drug)

fascia iliaca blockade

Active Comparator

Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control

干预措施: Fascia iliaca blockade (Procedure)

结局指标

主要结局

Visual Analogue Scale

时间窗: post op days 1-4 (Average VAS score of first 4 days of post op)

pain scale Questionnaire 0 equals no pain at all and 10 equals the worst. The out come measure time frame is reported as the average VAS score of the first 4 day post op.

次要结局

  • Narcotic Utilization(total pill taken over the course of days 1-4 post op.)
  • Total Number of at Home Falls.(Post op days 1-7)

研究者

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

Michael Banffy, MD

Director, Orthopaedic Sports Medicine Fellowship

Cedars-Sinai Medical Center

研究点 (1)

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