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临床试验/NCT05044429
NCT05044429终止4 期

Postoperative Pain Control With Systemic Lidocaine vs. Regional Anesthesia in Renal Transplant Patients

George Washington University1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2021年3月16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
31
试验地点
1
主要终点
Opioid Utilization (24 Hour Post-operative)

研究概览

简要总结

This study aims to compare the effectiveness of a regional anesthetic block vs systemic intravenous (IV) lidocaine in controlling post-operative pain in kidney transplantation patients. Regional anesthetic blocks and lidocaine infusions are effective alternatives to opioid medications and are already in use at many institutions. However, there has been no prospective study comparing their effectiveness when used in conjunction with the current standard of care patient controlled analgesia (PCA) pumps. This study is a prospective, randomized evaluation of both treatment methods.

详细描述

Adequate postoperative pain control is an important part of the patients' recovery. Renal transplant patients often have multiple comorbidities, that when combined with poorly controlled postoperative pain, can lead to tachycardia, hypertension, and increased risk of respiratory complications, which can in turn affect overall recovery and graft survival.

The use of patient-controlled analgesia (PCA) pumps is currently considered the standard of care in treating surgical pain in the immediate postoperative period. Although a traditional mainstay of therapy, opioids have an unfavorable side effect profile that includes respiratory depression, nausea, postoperative ileus, sedation, and pruritus. Additionally, long-term opioid use is linked with opioid tolerance, addiction, and patient death. Patients that have high-level opioid use in the first year posttransplant have been found to have high rates of death and all-cause graft failure.

Recently, there has been a shift in post-operative pain management to utilize a multimodal approach of both non-pharmacologic and pharmacologic therapies. As a result, the use of other non-opioid therapies, such as lidocaine infusions and regional anesthetic techniques, like transverse abdominis plane blocks, have recently increased in popularity in perioperative pain management of renal transplant patients.

Intravenous lidocaine has an off label indication as analgesic and has good evidence for use in other areas such as colorectal surgery, trauma and orthopedics. Lidocaine infusions have a strong record of safety with relatively benign adverse side effects. Although data is promising, there is little established evidence of perioperative lidocaine infusions in renal transplant populations.

Transverse abdominis plane (TAP) blocks and quadratus lumborum (QL) blocks have emerged as a significant regional technique in the application of multimodal analgesia for abdominal surgeries. Historically, TAP and QL catheters are avoided due to concern about infection near the operative site in immunosuppressed transplant patients. Establishing intravenous lidocaine as an effective treatment option will allow physicians to avoid the side effects of opioids and the infection risks of TAP and QL catheter blocks.

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
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unilateral renal transplant

排除标准

  • History of chronic pain, chronic opioid use, or opioid use disorder
  • Cardiac arrythmia, cardiac failure
  • Hepatic Failure
  • Local anesthetic allergy (allergy to lidocaine and ropivacaine)
  • Complicated surgical course including intraoperative damage to other organs (bowel)
  • Return to operating room within 72hours

研究组 & 干预措施

Intravenous Lidocaine

Experimental

干预措施: Intravenous Lidocaine (Drug)

Transversus abdominis plane (TAP) block

Active Comparator

干预措施: Transversus abdominis plane (TAP) block (Drug)

Quadratus Lumborum (QL) Block

Active Comparator

干预措施: Quadratus Lumborum (QL) Block (Drug)

结局指标

主要结局

Opioid Utilization (24 Hour Post-operative)

时间窗: 24 hours after surgery

We are measuring oral morphine equivalents to assess for study intervention efficacy at 24 hours after surgery

Pain Level (48 Hour Post-operative)

时间窗: 48 hours after surgery

Measured using visual analog scale (0-10), 0 is the best and 10 is the worst score at 48 hours after surgery

Opioid Utilization (36 Hour Post-operative)

时间窗: 36 hours after surgery

We are measuring oral morphine equivalents to assess for study intervention efficacy at 36 hours after surgery

Opioid Utilization (48 Hour Post-operative)

时间窗: 48 hours after surgery

We are measuring oral morphine equivalents to assess for study intervention efficacy at 48 hours after surgery

Pain Level (12 Hour Post-operative)

时间窗: 12 hours after surgery

Measured using visual analog scale (0-10), 0 is the best and 10 is the worst score at 12 hours after surgery

Pain Level (24 Hour Post-operative)

时间窗: 24 hours after surgery

Measured using visual analog scale (0-10), 0 is the best and 10 is the worst score at 24 hours after surgery

Opioid Utilization (12 Hour Post-operative)

时间窗: 12 hours after surgery

We are measuring oral morphine equivalents to assess for study intervention efficacy at 12 hours after surgery

Pain Level (36 Hour Post-operative)

时间窗: 36 hours after surgery

Measured using visual analog scale (0-10), 0 is the best and 10 is the worst score at 36 hours after surgery

次要结局

  • Vital Status(Through hospital discharge, approximately four days)
  • Number of Acute Rejection of Renal Transplant(Up to one week)
  • Number of Patients Who Need Continuous Veno-venous Hemodiafiltration (CVVHDF) After Renal Transplant(By time of hospital discharge, approximately four days)
  • Number of Patients With Symptoms of Opioid Toxicity After Renal Transplant(Through hospital discharge, approximately four days)
  • Number of Subjects With Local Anesthetic Systemic Toxicity (LAST)(Through hospital discharge, approximately four days)
  • Number of Subjects With Postoperative Sepsis(Through hospital discharge, approximately three days)
  • Number of Patients With Ileus After Renal Transplant(Through hospital discharge, approximately four days)
  • Total Length of Hospital Stay(Through hospital discharge, approximately four days)
  • Length of Intensive Care Unit Stay(Through hospital discharge, approximately four days)

研究者

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

Eric Heinz

Associate Professor of Anesthesiology and Critical Care

George Washington University

研究点 (1)

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