跳至主要内容
临床试验/NCT03409900
NCT03409900已完成不适用

Lumbar Plexus Block Versus Quadratus Lumborum Block for Primary Anterior Total Hip Arthroplasty: A Non-inferiority Trial

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年3月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Verbal numeric pain score with hip flexion at 6hrs (Numeric Rating Scale (NRS))

研究概览

简要总结

Total hip arthroplasty (THA) is one of the most successful orthopedic procedures to effectively relieve pain and restore function in patients with end stage osteoarthritis. In an attempt to accelerate recovery many orthopedic surgeons have opted to utilize a direct anterior approach (DAA) as opposed to the more traditional posterolateral approach (PLA). The literature supports that DAA is superior to PLA with regard to lower blood loss, less pain, shorter hospital stay, and faster rehabilitation. Traditionally the study team has performed Lumbar Plexus blocks (LPB) to provide post-operative analgesia for total hip arthroplasty. The quadratus lumborum block (QLB) is a newer regional analgesic technique that may be as effective as LPB at providing pain control following DAA hip arthroplasty. This study is designed to compare the efficacy, with regards to post-operative pain management, between LPB and QLB following a DAA total hip arthroplasty.

详细描述

In an attempt to accelerate recovery many orthopedic surgeons have opted to utilize a direct anterior approach (DAA) as opposed to the more traditional posterolateral approach (PLA) in regards to total hip arthroplasty (THA). The DAA technique involves dissection of muscular planes for insertion of components resulting in less tissue damage as compared to PLA. Traditionally the study team has performed Lumbar Plexus blocks (LPB) to provide post-operative analgesia for total hip arthroplasty. This technique works well for the traditionally performed PLA in that the hip joint and incision site are within the analgesic distribution of the LPB. Conversely, the DAA utilizes an anterior incision that overlies the L1 and L2 dermatomes as opposed to the lower lumbar dermatomes of the PLA incision. When performing LPB it has been the study team's clinical experience that it is rare to achieve analgesia in the proximal distribution of the lumbar plexus resulting in apparent sparing of the L1 and L2 nerve root distributions. The quadratus lumborum block (QLB) is a newer regional analgesic technique that may be as effective as LPB at providing pain control following DAA hip arthroplasty. The QLB is thought to provide analgesia by blocking both the lateral and anterior cutaneous branches of T7 through L4. This degree of dermatomal coverage suggests that QLB could be an efficacious alternative to LPB for DAA hip arthroplasty. It is hypothesized that the QLB will provide equivalent analgesia when compared to the LPB as determined by a comparison of verbal reported pain scores.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient between the ages of 18 and 95 years undergoing a primary elective, unilateral DAA total hip arthroplasty.

排除标准

  • If the patient uses more than 40mg of Oxycodone equivalents per 24 hours or is on extended release opioid formulations.
  • Indication for surgery is secondary to trauma and/or hip fracture
  • If there is a contraindication to the performance of a regional block
  • Concomitant anticoagulation use or documented coagulopathy
  • Infectious or dermatologic conditions in the area of block placement that would otherwise increase the risk of peripheral nerve blockade
  • Presence of progressive neurologic deficit effecting peripheral nerves
  • Allergy or adverse reaction to study drugs to include: fentanyl, epinephrine, and amide local anesthetics
  • American Society of Anesthesia Physical Classification score > or = to 4
  • Allergies to study drugs other than local anesthetic
  • BMI > 40
  • Patient refusal
  • Pregnancy
  • Institutionalized individuals
  • Extremes of age: Age > 95 or < 18
  • Non English speaking or inability to reliably participate in the study

结局指标

主要结局

Verbal numeric pain score with hip flexion at 6hrs (Numeric Rating Scale (NRS))

时间窗: 6 hours post block

Quantified on an 10 point pain scale with 0 representing "no pain" and 10 representing "worst pain imaginable". Higher scores denotes worse outcomes.

次要结局

  • Rates of opioid related side effects (nausea, vomiting, pruritis)(Within 24hrs post block)
  • Patient satisfaction utilizing a Likert-scale questionnaire(Post operative day 1)
  • Time to first analgesic(During hospitalization, up to 24hrs)
  • Total opioid consumption over 24 hours(24 hrs post block)
  • Verbal numeric pain score at 6hrs at rest (NRS)(6hrs post block)
  • Ability to straight leg raise on POD1(Post operative day 1)
  • Verbal numeric pain score at rest and with movement at 24hrs post block(24hrs post block)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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