跳至主要内容
临床试验/NCT03502889
NCT03502889Unknown不适用

Single Dose Adductor Canal Block With SPANK (Sensory Posterior Articular Nerves of the Knee) Block Compared to Single Dose Adductor Canal Block and Pain Control After Total Knee Arthroplasty

San Antonio Uniformed Services Health Education Consortium0 个研究点目标入组 128 人开始时间: 2019年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
128
主要终点
Postoperative Opioid Consumption

研究概览

简要总结

This is a prospective, randomized control trial to compare SPANK block combined with adductor canal block to adductor canal block alone in treatment of post-operative pain after total knee arthroplasty. The primary outcome is pain control, which will be measured throughout the post-operative course using morphine equivalents of opioid analgesics used during the first 24 hours after surgery. Secondary outcomes include pain scores recorded at 4, 8, 12, 16, 20, and 24 hours post-operatively, cumulative pain score, incidence of post-operative nausea and vomiting, and extent of motor blockade. The study will aid in answering the question of whether SPANK block is an effective adjunct in preventing pain and decreasing opioid requirement after TKA.

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
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between the ages of 40 and 80 years old undergoing total knee arthroplasty amenable to peripheral nerve block for perioperative analgesia.
  • ASA class III or less

排除标准

  • Inability to sign consent form
  • Allergy to medications used in the study
  • Repeat surgery
  • History of seizure disorder
  • Simultaneous bilateral TKA
  • History of substance abuse
  • Opioid consumption of greater or equal to 30mg morphine equivalents per day
  • Age <40 or >80 years old
  • ASA IV or greater
  • Inability to use a PCA
  • Inability to access the intrathecal space
  • Infection at the site of injection (either for spinal or PNB)
  • INR greater than or equal to 1.4

研究组 & 干预措施

Adductor Canal Block Alone

Active Comparator

Control arm to receive Adductor Canal Block without additional interventions Intervention: ropivacaine 0.5% 15cc injected under ultrasound guidance

干预措施: Adductor Canal Block (Procedure)

Adductor Canal Block Alone

Active Comparator

Control arm to receive Adductor Canal Block without additional interventions Intervention: ropivacaine 0.5% 15cc injected under ultrasound guidance

干预措施: Ropivacaine Hcl 0.5% Inj Vil 30Ml (Drug)

Adductor Canal Block Alone

Active Comparator

Control arm to receive Adductor Canal Block without additional interventions Intervention: ropivacaine 0.5% 15cc injected under ultrasound guidance

干预措施: Pajunk sonoplex stim needle (Device)

SPANK Block Plus Adductor Canal Block

Experimental

Experimental arm to receive Adductor Canal Block plus SPANK Block (Sensory Posterior Articular Nerves of the Knee) without additional interventions Intervention: ropivacaine 0.5% 15cc injected under ultrasound guidance into the adductor canal plus 20cc ropivacaine 0.5% injected into the posterior tissues of the knee

干预措施: SPANK Block (Sensory Posterior Articular Nerves of the Knee) (Procedure)

SPANK Block Plus Adductor Canal Block

Experimental

Experimental arm to receive Adductor Canal Block plus SPANK Block (Sensory Posterior Articular Nerves of the Knee) without additional interventions Intervention: ropivacaine 0.5% 15cc injected under ultrasound guidance into the adductor canal plus 20cc ropivacaine 0.5% injected into the posterior tissues of the knee

干预措施: Adductor Canal Block (Procedure)

SPANK Block Plus Adductor Canal Block

Experimental

Experimental arm to receive Adductor Canal Block plus SPANK Block (Sensory Posterior Articular Nerves of the Knee) without additional interventions Intervention: ropivacaine 0.5% 15cc injected under ultrasound guidance into the adductor canal plus 20cc ropivacaine 0.5% injected into the posterior tissues of the knee

干预措施: Ropivacaine Hcl 0.5% Inj Vil 30Ml (Drug)

SPANK Block Plus Adductor Canal Block

Experimental

Experimental arm to receive Adductor Canal Block plus SPANK Block (Sensory Posterior Articular Nerves of the Knee) without additional interventions Intervention: ropivacaine 0.5% 15cc injected under ultrasound guidance into the adductor canal plus 20cc ropivacaine 0.5% injected into the posterior tissues of the knee

干预措施: Pajunk sonoplex stim needle (Device)

结局指标

主要结局

Postoperative Opioid Consumption

时间窗: 24 hours postoperatively

Amount of opioids used within the first 24 hours post-operatively, starting from when the patient leaves the operating room, measured in PO morphine equivalents

次要结局

  • Time to first opioid use(24 hours postoperatively)
  • Postoperative Pain Scores(4, 8, 12, 16, and 24 hours postoperatively)

研究者

发起方
San Antonio Uniformed Services Health Education Consortium
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Angela Curell

Anesthesiology Resident

San Antonio Uniformed Services Health Education Consortium

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