跳至主要内容
临床试验/NCT05856539
NCT05856539招募中不适用

Erector Spinae Plane Block in Patients Undergoing Minimally Invasive Lumbar Spine Surgery: A Randomized Controlled Trial

Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
48
试验地点
1
主要终点
24-hour oral morphine milligram equivalents (OMEs)

研究概览

简要总结

This is a prospective, randomized controlled trial of patients undergoing minimally invasive transforaminal lumbar interbody fusion. This study will randomize patients into one of two groups: erector spinae plane (ESP) block and no ESP block.

详细描述

Minimally invasive (MIS) spinal surgical procedures such as MIS transforaminal lumbar interbody fusion (TLIF) are being increasingly performed due to reduced morbidity. However, the mainstay for perioperative analgesia after these surgeries remains to be opioid pain medications, which have a number of associated adverse effects such as respiratory depression, hyperalgesia, and opioid habituation. Recently, the erector spinae plane (ESP) block has been introduced as an opioid-sparing regional anesthetic for lumbar spinal surgery with touted benefits including opioid use reduction and improved pain control. The proposed study aims to enroll patients in a double blind randomized controlled trial to undergo MIS TLIF with an ESP block or as conventional control group. Preoperative patient demographics, comorbidities, history of opioid use, and operative details will be obtained. Comprehensive assessment of opioid utilization, postoperative pain, non-opioid pain medication use, opioid-induced complications, time to opioid cessation, time to physical therapy clearance, length of stay, as well as other related outcomes will be performed.

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
Single (Participant)

盲法说明

Patients will be blinded to randomization (whether or not they received an ESP block preoperatively). Co-investigators will not be blinded as the anesthesiologist will need to perform the ESP block.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-80
  • Patients scheduled for MIS TLIF (any level) with the principal investigator
  • ASA 1, 2, 3

排除标准

  • ASA 4 or higher
  • Chronic opioid use (daily use for > 3 months)
  • Revision surgery, any history of previous lumbar spine surgery
  • Allergy to any of the study medications
  • Non-English speaking
  • Chronic renal insufficiency or failure (creatinine >2) or severe hepatic disease (cirrhosis, failure)
  • Pregnancy
  • Any concomitant surgery

结局指标

主要结局

24-hour oral morphine milligram equivalents (OMEs)

时间窗: 24 hours postoperatively

The primary outcome of the study will be cumulative opioid use in the first 24 hours postoperatively in oral morphine milligram equivalents (OMEs) (24 hour period from PACU admission to POD1).

次要结局

未报告次要终点

研究者

发起方
Hospital for Special Surgery, New York
申办方类型
Other
责任方
Sponsor

研究点 (1)

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