跳至主要内容
临床试验/NCT05161221
NCT05161221Unknown3 期

Adductor Canal Block With Liposomal Bupivacaine (Exparel) Versus Femoral Nerve Catheter for Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Trial

Rothman Institute Orthopaedics1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2021年12月6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
154
试验地点
1
主要终点
Patient satisfaction

研究概览

简要总结

Liposomal bupivacaine injectable suspension (Exparel), manufactured by Pacira Pharmaceuticals, is an FDA-approved, long-lasting nonopioid analgesic that is indicated for single-dose infiltration in adults to produce postsurgical local analgesia. Exparel's extended bioavailability allows for 48 hours of pain control. Periarticular infiltration of liposomal bupivacaine has been safely and effectively used for total knee arthroplasty as an alternative to FNBs, avoiding transient quadriceps weakness and potential in-hospital falls. Recently Exparel has been FDA approved for interscalene brachial plexus nerve block to produce postsurgical regional analgesia for upper extremity/shoulder procedures. It is not yet approved for peripheral nerve blocks of the lower extremity.

No study to date, to our knowledge, has evaluated the efficacy of single-dose adductor canal blockade with Exparel compared to femoral nerve catheter with bupivacaine. We pose that Exparel used for an adductor canal block can offer the benefit of a single-dose injection with extended pain control without the burden of an indwelling catheter and to avoid adverse events of femoral nerve blockade related to quadriceps weakness and dysesthesias.

The purpose of this study is to determine whether adductor canal blockade with liposomal bupivacaine (Exparel) is a safe and effective alternative to femoral nerve catheters for post-operative pain control for patients undergoing ACL reconstruction.

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

  • Patients undergoing primary anterior cruciate ligament reconstruction with autograft
  • Has not used narcotic pain medication in 3 months
  • Ages of 18+
  • Proficient in the English language
  • Willing and able to follow study protocol

排除标准

  • ACL repair, revision surgery, or allograft
  • Multi-ligamentous knee injuries
  • Cartilage procedures that prevented adherence to the immediate weightbearing and range of motion rehabilitation protocol
  • Patients taking baseline opioid for other injury
  • Dementia or other psychiatric illness that would preclude accurate evaluation
  • Pregnant or lactating patients
  • Non-English speakers as questionnaires are only available in English

研究组 & 干预措施

Pre-operative femoral nerve catheter

Active Comparator

participants undergoing ACL reconstruction surgery will receive a femoral prior to their surgery

干预措施: OxyCODONE 5 mg Oral Tablet (Drug)

Pre-operative femoral nerve catheter

Active Comparator

participants undergoing ACL reconstruction surgery will receive a femoral prior to their surgery

干预措施: Naproxen 500 Mg (Drug)

Pre-operative femoral nerve catheter

Active Comparator

participants undergoing ACL reconstruction surgery will receive a femoral prior to their surgery

干预措施: Tylenol Pill (Drug)

Pre-operative femoral nerve catheter

Active Comparator

participants undergoing ACL reconstruction surgery will receive a femoral prior to their surgery

干预措施: Femoral Nerve Catheter (Procedure)

Pre-operative adductor canal block with liposomal bupivacaine

Active Comparator

participants undergoing ACL reconstruction surgery will receive a nerve block using liposomal Bupivacaine (Exparel)

干预措施: OxyCODONE 5 mg Oral Tablet (Drug)

Pre-operative adductor canal block with liposomal bupivacaine

Active Comparator

participants undergoing ACL reconstruction surgery will receive a nerve block using liposomal Bupivacaine (Exparel)

干预措施: Naproxen 500 Mg (Drug)

Pre-operative adductor canal block with liposomal bupivacaine

Active Comparator

participants undergoing ACL reconstruction surgery will receive a nerve block using liposomal Bupivacaine (Exparel)

干预措施: Tylenol Pill (Drug)

Pre-operative adductor canal block with liposomal bupivacaine

Active Comparator

participants undergoing ACL reconstruction surgery will receive a nerve block using liposomal Bupivacaine (Exparel)

干预措施: Liposomal bupivacaine (Drug)

结局指标

主要结局

Patient satisfaction

时间窗: 8 weeks

Participant will record Patient Satisfaction through Visual Analog Scale for pain

Post operative pain management

时间窗: 8 weeks

Participant will record quadriceps function tests

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