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临床试验/NCT05094427
NCT05094427已完成不适用

Perioperative Local Anesthesia Block in Spine Surgery: A Retrospective Chart Review

Columbia University1 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2021年3月10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
232
试验地点
1
主要终点
Total PACU opioid requirements

研究概览

简要总结

The purpose of the this study to evaluate the feasibility, safety, and efficacy of a fluoroscopically-guided dorsal ramus block placed by the operative neurosurgeon prior to lumbosacral surgery. The study will consist of a retrospective analysis of a cohort of patients who underwent lumbosacral surgery patients between June 2018 and March 2021 with or without a preoperative fluoroscopically-guided dorsal ramus (DR) block placed by the operative neurosurgeon.

详细描述

Spine surgery poses unique challenges in postoperative pain management. Local anesthetic blocks, namely the erector spinae plane and thoracolumbar interfacial plane blocks, placed by anesthesia under ultrasound guidance have been shown to reduce postoperative pain after spinal surgery and decrease perioperative opioid requirements by as much as 50%. Nonetheless these procedures are not routinely performed, likely due to logistical hurdles and lack of widespread knowledge of the procedure by anesthesiologists. A preoperative dorsal ramus block performed by the operative neurosurgeon under fluoroscopy shows promise as an alternative approach to perioperative pain control. The objective of this retrospective observational study is to evaluate the feasibility, safety, and efficacy of a dorsal ramus block block performed by a neurosurgeon under x-ray guidance prior to lumbar surgery. The study will include a cohort of patients who have undergone lumbar spine surgery with or without the x-ray guided dorsal ramus block. A retrospective chart review of these patients will be performed to assess for postoperative pain control, postoperative opioid requirements, time to block completion, length of stay, and adverse events. Descriptive and comparative statistics will be performed. No new data will be gathered from the subjects beyond pre-existing data within the medical record, and no new procedures will be performed as part of the study. If the current study suggests that a dorsal ramus block performed by the operative neurosurgeon is feasible, safe, and effective, it will serve as a foundation for a randomized clinical trial of such a block among patients undergoing lumbar surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Patients aged 18 years and older
  • Patients undergoing lumbar spine surgery at any spinal level from L1 to sacrum (including decompression, discectomy, posterior fusion, interbody fusion, wound revision or washout, intradural tumor resection, treatment of vascular spinal lesion, tethered cord release, repair of cerebrospinal fluid (CSF) leak, hardware removal)

排除标准

  • Patients undergoing surgery that includes thoracic levels
  • Patients from whom pain scores could not be elicited in the immediate postoperative period due to mental status (e.g. prolonged intubation requirement, etc.)

结局指标

主要结局

Total PACU opioid requirements

时间窗: Within the first 24 hours of surgery

Total opioids received within the PACU prior to discharge home or transfer to floor (oral morphine equivalents)

First visual analog scale (VAS) pain score in the post-anesthesia care unit (PACU)

时间窗: Within the first 24 hours of surgery

The first VAS pain score recorded within the PACU on a 0-10 scale, with 0 indicating no pain (better outcome) and 10 indicating more pain (worse outcome).

次要结局

  • Total number of adverse events(Up to 24 hours from start of DR block placement)
  • Length of Stay (in hours to days)(Up to 30 days from completion of surgery during hospital course)
  • Time required to perform block (in minutes)(Up to 30 minutes from start of DR block placement)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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