临床试验/CTRI/2024/06/068960

CTRI/2024/06/068960尚未招募不适用

Enhanced recovery in elective lumbar spine surgeries- A randomized controlled study

SIMS Hospitals1 个研究点分布在 1 个国家目标入组 150 人开始时间: 2024年7月1日最近更新: 2024年6月13日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 150
试验地点: 1
主要终点: Postoperative length of stay and total hospitalisation cost

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Use of ERAS protocol in the test group of patients undergoing elective spine surgeries who satisfy the inclusion and exclusion criteria and assessing the length of hospital stay, total hospitalisation cost, readmission rates within 30 days of discharge. Use of standard care in control group and comparing the outcomes

研究设计

研究类型: Interventional
分配方式: Coin toss, Lottery, toss of dice, shuffling cards etc

入排标准

年龄范围: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•ASA grades 1 and 2, patients admitted for lumbar spine surgeries including transforaminal interlumbar body fusion, posterior lumbar decompression and stabilization, lumbar microdissectomy and percutaneous lumbar stabilization.

排除标准

•ASA grades 3 and 4, patients with major comorbid conditions, pregnant and lactating mothers, obese individuals with BMI more than or equal to 30, patients with drug allergies or egg allergy , patients participating in any other clinical studies, patients with major neurological deficits.

结局指标

主要结局

Postoperative length of stay and total hospitalisation cost

时间窗: From time of admission to discharge

次要结局

Readmission rates, postoperative complications, postoperative pain scores, peri operative opioid consumption, length of ICU stay, duration of drainage tube, time to first oral intake , postoperative functional recovery status(30 days from discharge)

研究者

发起方

SIMS Hospitals

申办方类型

Research institution and hospital

责任方

Principal Investigator

主要研究者

Dr Magimairaj

SIMS Hospital

研究点 (1)

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