跳至主要内容
临床试验/NCT04717609
NCT04717609Unknown3 期

Surgeon Performed Saphenous Nerve Block at the Medial Femoral Condyle for Arthroscopic Partial Meniscectomy and Meniscus Repair: A Randomized Control Trial

Rothman Institute Orthopaedics1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2021年1月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
160
试验地点
1
主要终点
Reduced Pain Levels

研究概览

简要总结

Partial meniscectomy and meniscus repair are two of the most common orthopedic surgery procedures. As these procedures are being increasingly performed in ambulatory surgical centers, there has been a shift towards providing improved analgesia to ensure timely discharge, as well as preventing unwanted pain and side effects. As such, it has become common practice to use an intra-articular injection of local anesthetic to achieve post-operative pain control. However, these effects are short lived, requiring a multimodal approach to analgesia. To date, no optimal pain control strategy has been described for arthroscopic partial meniscectomy or meniscus repair. The purpose of this study is to examine the outcomes of subcutaneous saphenous nerve block with 0.5% ropivacaine at the medial femoral epicondyle/adductor hiatus plus portal 0.5% ropivacaine injection vs portal 0.5% ropivacaine injection alone for patients undergoing arthroscopic partial meniscectomy or meniscus repair.

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

入选标准

  • Scheduled for arthroscopic meniscectomy or meniscus repair

排除标准

  • Multiple-ligament injury
  • Primary ACL reconstruction or ACL revision reconstruction
  • Articular cartilage restoration surgery
  • Evidence of microfracture
  • History of allergy to local anesthetics
  • Pre-existing saphenous neuropathy
  • Unable to be prescribed opioids due to allergy or other reason

研究组 & 干预措施

Partial Meniscectomy without Saphenous Nerve Block

Active Comparator

Participants scheduled for partial meniscectomy will preoperatively receive 0.5% ropivacaine with epinephrine

干预措施: Ropivacaine injection (Drug)

Partial Meniscectomy with Saphenous Nerve Block

Experimental

Participants scheduled for a partial meniscectomy will preoperatively receive a saphenous nerve block at the medial femoral condyle in addition to an injection of 0.5% ropivacaine with epinephrine

干预措施: Saphenous Nerve Block (Procedure)

Partial Meniscectomy with Saphenous Nerve Block

Experimental

Participants scheduled for a partial meniscectomy will preoperatively receive a saphenous nerve block at the medial femoral condyle in addition to an injection of 0.5% ropivacaine with epinephrine

干预措施: Ropivacaine injection (Drug)

结局指标

主要结局

Reduced Pain Levels

时间窗: 10 days

This will be measured using the numeric rating score (NRS). It will be collected at 1 and 10 days after surgery

Quality of Recovery

时间窗: 20 minutes

After surgery while in the recovery room a 40 question survey will be administered regarding your comfort level, emotional state and pain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验