跳至主要内容
临床试验/NCT02851888
NCT02851888Unknown4 期

Use of Regional Anesthesia in Hip Arthroscopy

Georgetown University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2016年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
70
试验地点
1
主要终点
Pain Medication Requirement in PACU

研究概览

简要总结

The purpose of this research is to determine differences in outcomes in patients who do, or do not, receive regional anesthesia (a fascia iliaca block) prior to undergoing hip arthroscopy with labral repair and/or debridement and osteoplasty for hip impingement

详细描述

Patients undergoing hip arthroscopy for hip impingement at the investigator's institution often have regional anesthesia (a nerve block) prior to the procedure to help prevent and/or reduce pain following the procedure. The investigators are interested in determining benefits as well as potential adverse effects of utilizing regional anesthesia in patients undergoing hip arthroscopy for impingement. To do so, they plan to enroll patients aged 18-50 undergoing hip arthroscopy, and randomize them to one of two groups with one group receiving regional anesthesia pre-operatively and the second control group, that does not. The surgical procedure and the post-operative management will be the same for both groups.

Regional anesthesia prior to orthopaedic procedures has been widely adopted in many fields of orthopaedics. While it is generally considered safe and an excellent adjuvant for pain control, there have been few studies exploring outcomes beyond pain control. In many centers, the use of regional anesthesia in hip arthroscopy is reserved for post-operative management of pain. There are multiple studies indicating that patients receiving regional anesthesia (a fascia iliaca or femoral nerve block) had significantly greater improvements in pain score and even an excellent alternative to routine narcotic medication in patients undergoing hip arthroscopy. Other orthopaedic procedures, such as knee arthroscopy, utilize similar techniques to achieve post-operative pain control through a femoral-sciatic nerve block.

There have also been studies looking at the utilization of regional anesthesia via lumbar plexus blocks with hip arthroscopy. One study found that patients undergoing hip arthroscopy with higher levels of preoperative psychological distress frequently utilized a lumbar plexus block to achieve adequate pain control. Other studies found that lumbar plexus blocks significantly improved pain while in the PACU. While serious complications of lumbar plexus block were rare, minor complications such as falls, persistent paresthesias, and unexpected admissions do occur. At our institution, we do not utilize lumbar plexus blocks for regional anesthesia in patients undergoing hip arthroscopy. Rather, our standard of care is to have an anesthesiologist perform a single shot fascia iliaca block using ropivicaine while the patient is in the pre-operative holding bay.

To the investigative team's knowledge, there are no studies comparing the difference in pain control, as well as the differences in narcotic requirements in PACU, duration of stay in PACU, reported falls, unplanned admissions and/or readmissions, Harris hip score and nerve pain/paresthesias/numbness in patients who have undergone hip arthroscopy with and without regional anesthesia. A better understanding of pain and functional outcomes following hip arthroscopy with and without regional anesthesia can help providers better assess circumstances when regional anesthesia can be beneficial or detrimental to a patient's post-operative course.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled for arthroscopic labral repair with or without osteoplasty of the hip.
  • 18 to 50 years old
  • American Society of Anesthesiologists Physical Status (ASA PS) score of I or II.

排除标准

  • Current or planned pregnancy
  • History of neuropathic pain, chronic pain syndrome, or preoperative use of narcotic or neuropathic pain medicine
  • Radiographic signs of osteoarthritis (> Tonis grade 1)
  • Inability to attend follow up visits
  • Documented allergy to local anesthetic

研究组 & 干预措施

Iliac Fascia Block (Ropivacaine)

Experimental

These patients will receive a preoperative iliac fascia block performed as a single shot in the standard fashion prior to hip arthroscopy with general anesthesia.

干预措施: Ropivacaine (Drug)

Iliac Fascia Block (Ropivacaine)

Experimental

These patients will receive a preoperative iliac fascia block performed as a single shot in the standard fashion prior to hip arthroscopy with general anesthesia.

干预措施: General Anesthesia (Procedure)

Control (Normal Saline Sham Injection)

Sham Comparator

These patients will receive a preoperative sham block of normal saline in the same fashion as a standard singl shot iliac fascia block prior to hip arthroscopy with general anesthesia.

干预措施: Normal Saline Sham Injection (Other)

Control (Normal Saline Sham Injection)

Sham Comparator

These patients will receive a preoperative sham block of normal saline in the same fashion as a standard singl shot iliac fascia block prior to hip arthroscopy with general anesthesia.

干预措施: General Anesthesia (Procedure)

结局指标

主要结局

Pain Medication Requirement in PACU

时间窗: 24 hours post-operatively

Measured in morphine equivalents

次要结局

  • Visual Analogue Pain Scores (VAS)(24 hours post-operatively)
  • Duration of PACU stay (mins)(24 hours post-operatively)
  • Falls(6 weeks)
  • Neuropathic Pain(2 weeks and 6 weeks)
  • Readmissions(6 weeks)
  • Time to Physical Therapy(6 weeks)
  • Long Term Pain Control (daily VAS record)(6 weeks)
  • Modified Harris hip score(6 weeks)
  • Long Term Medication Requirements (daily log of medication usage in tablets of 5 mg oxycodone, morphine extended relief 15 mg, and/or indomethacin 75 mg)(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Use of Regional Anesthesia in Hip Arthroscopy | 临床试验