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临床试验/CTRI/2024/07/070190
CTRI/2024/07/070190
尚未招募
不适用

Analgesic efficacy of ultrasound guided erector spinae fascial plane block in lumbar spine surgeries- a prospective randomised controlled study

All India Institute of Medical Sciences Kalyani1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年8月1日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
All India Institute of Medical Sciences Kalyani
入组人数
50
试验地点
1
主要终点
1)Time to first request of analgesia. Postoperative pain scores assessed using Visual Analog Scale (VAS) at 6,12 and 24 hours postoperatively

概览

简要总结

Aim of this study is to assess the analgesic efficacy of ultrasound guided erector spinae block with standardized multimodal analgesic technique in patients undergoing posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) surgeries.Assessing the impact of ESB on opioid consumption, postoperative nausea and vomiting (PONV), time to ambulation, length of hospital stay, and patient satisfaction.

Previous studies show promising results, however proper study with adequate sample size and assessment of association with any possible complications is yet to be assessed.

One group of patients will receive bilateral erector spinae block followed by i.v fentanyl via PCA pump in post operative period and other group will not receive any block and will get i.v fentanyl via PCA pump in post operative period.Then we will assess time to first request of analgesia, postoperative pain scores assessed using Visual Analog Scale (VAS) at specified time points and total opioid consumption in the first 24 hours postoperatively.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • ASA I and ASA II 2) Scheduled for elective lumbar spine surgery (PLIF and TLIF) 3)Lumbar spine surgery involving not more than three levels.

排除标准

  • Patients with pre-existing neurological deficits 2)Patients undergoing emergency or revision lumbar spine surgery 3)Patients with contraindications to erector spinae block 4) Patients with opioid dependence.
  • Patient with scoliosis.

结局指标

主要结局

1)Time to first request of analgesia. Postoperative pain scores assessed using Visual Analog Scale (VAS) at 6,12 and 24 hours postoperatively

时间窗: In first 24 hours postoperatively at 6th hour,12th hour and 24th hour

2)Total opioid consumption in first 24 hours postoperatively

时间窗: In first 24 hours postoperatively at 6th hour,12th hour and 24th hour

次要结局

  • 1.Incision response(2.Surgical field experience)

研究者

发起方
All India Institute of Medical Sciences Kalyani
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Anuja Kumari Saha

All India Institute of Medical Sciences, Kalyani

研究点 (1)

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