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临床试验/NCT04917055
NCT04917055终止4 期

Impact of Adding iPACK Block With Dexamethasone to Existing APS Multimodal Analgesia Protocol for Patients Undergoing Total Knee Arthroplasty

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2021年6月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
14
试验地点
1
主要终点
Average Opioid Use POD 0-1

研究概览

简要总结

Comparing the pain control outcomes for patients undergoing total knee arthroplasty (TKA) with either: 1) adductor canal single shot injection plus placebo iPACK injection or 2) adductor canal single shot injection plus bupivacaine and dexamethasone iPACK injection.

There are two surgical approaches for TKA 1) open 2) ROSA robotic assisted. Both follow the same pain management pathway. We plan to enroll patient undergoing either surgical procedure.

详细描述

This will be a single-center (UCSD), randomized blinded investigation.

Enrollment. Consenting adults undergoing TKA will be offered enrollment. Study inclusion will be proposed to eligible patients prior to surgery. If a patient desires study participation, written, informed consent will be obtained using a current UCSD IRB-approved ICF.

Preoperative Procedures. Following written, informed consent, we will record baseline anthropomorphic information (age, sex, height, and weight) that is already provided by all patients having surgery. After consenting and prior to surgery, patients will be randomized (utilizing sealed envelopes with 1:1 ratio) to either single-shot adductor canal block with sham iPACK block or single-shot adductor canal block with local anesthetic + dexamethasone iPACK block. A regional anesthesia fellow, not participating in the study, will open the sealed envelope and prepare the iPACK solution to be used accordingly.

Current Standard Care: Currently, all patients undergoing TKA receive preoperative adductor canal block as well as multimodal pain regimen managed by APS. They all receive intraoperative intraarticular injections by the surgical team. Spinal vs general anesthesia is decided at the discretion of the intraoperative anesthesiologist along with patient preferences and relevant contraindications. The only difference for subjects participating in the study (vs those not participating) will be that they will be randomized to receive an additional nerve block for posterior knee pain.

Adductor canal single shot block + Sham group: In the preoperative holding area, all subjects in this cohort will have a peripheral intravenous (IV) catheter inserted, standard noninvasive monitors applied, supplemental oxygen administered via a nasal cannula or face mask, and positioned supine. Midazolam and fentanyl (IV) will be titrated for patient comfort, while ensuring that patients remain responsive to verbal cues. The area of insertion will be cleaned with chlorhexidine gluconate and isopropyl alcohol (ChloraPrep One-Step, Medi-Flex Hospital Products, Inc., Overland Park, KS, USA). A single shot adductor canal block will be performed under ultrasound guidance with 20 mls of 0.25% ropivacaine with 1:400,000 epinephrine. A sensory level to ice will be confirmed and decided to be adequate if positive based on the discretion of the attending anesthesiologist. A Sham iPACK block will then be performed under ultrasound guidance, where 20 mls of 0.9% normal saline with 1:400,000 epi (as a vascular marker) is injected between the popliteal artery and the posterior aspect of the femoral condyle. As is standard for all TKA at our institution, all patients will additionally receive an intraoperative intraarticular injection by the surgical team of 50 mls 0.25% bupivacaine + 30 mg Ketorolac + 0.25mg epinephrine, which will occur at least 60 minutes after preoperative perineural injections.

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
Double (Participant, Outcomes Assessor)

盲法说明

Care provider and investigator will know if patient received SHAM or bupivacaine iPACK, but everyone else will be blinded

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

  • Having total knee arthroplasty at UC San Diego
  • Plan to receive single shot adductor canal injection preoperatively
  • Plan to receive spinal anesthetic with or without sedation for TKA surgery

排除标准

  • Pregnancy
  • Inability to communicate with anesthesia provider and/or investigators
  • Severe renal, hepatic, cardiac disease
  • Chronic high-dose opioid use (defined as daily use for more than 4 weeks prior to surgery of at least the equivalent of 20 mg oxycodone)
  • BMI > 45 kg/m2
  • Allergy to study medications (lidocaine, bupivacaine)
  • Incarceration

研究组 & 干预措施

Active Treatment

Active Comparator

Adductor Canal Single Shot with long acting local anesthetic (ropivacaine) plus distal iPACK (between femoral condyles) single shot with long acting local anesthetic (ropivacaine) plus dexamethasone

干预措施: ropivacaine 0.25% with epinephrine and 6mg dexamethasone (Drug)

Placebo

Placebo Comparator

Adductor Canal Single Shot with long acting local anesthetic (ropivacaine) plus iPACK single shot with normal saline

干预措施: Saline (Drug)

结局指标

主要结局

Average Opioid Use POD 0-1

时间窗: Postoperative day (POD) 0-1, as defined by 24 hours after iPACK block placement

Average Opioid Use

Average Pain Score with Motion

时间窗: Postoperative day (POD) 0-1, as defined by 24 hours after iPACK block placement

Average Pain Score with Motion

Average Pain Score at Rest

时间窗: Postoperative day (POD) 0-1, as defined by 24 hours after iPACK block placement

Average Pain Score at Rest

次要结局

  • Knee Range of motion(POD0-1 (first PT session))
  • Gait Distance(POD0-1 (first PT session))
  • Length of stay(Total number of days requiring hospitalization for surgical procedure. Up to 1 month)
  • Average Opioid Use postoperative day (POD) 1-2(Postoperative day (POD) 1-2.)
  • Average Pain Score, postoperative day (POD) 1-2.(Postoperative day (POD) 1-2.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Engy T. Said, MD

Clinical Professor

University of California, San Diego

研究点 (1)

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