跳至主要内容
临床试验/CTRI/2025/10/096316
CTRI/2025/10/096316尚未招募不适用

ERAS pathway in maxillofacial trauma: A prospective randomised comparison with conventional study

Department of Anaesthesia and Intensive care1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Length of hospital stay

研究概览

简要总结

ERAS pathways are patient centred, evidence based protocols involving multidisciplinary team replacing traditional practices of patient management and thereby enhance patient recovery and reduce number of days spent in the hospital. There are ERAS protocols for surgeries across various specialties but none for maxillofacial trauma. hence, this study is designed with the aim of formulating ERAS protocol for patients with maxillofacial injuries.

The methodology involves randomising patients with maxillofacial trauma meeting inclusion and exclusion criteria into two groups. One group receives the conventional care while the other group receives treatment according to the ERAS pathway formulated by us based on ERAS consensus guidelines for colorectal surgery. Length of hospital stay are compared along with other outcomes such as quality of recovery, perioperative opioid use, patient satisfaction and any complications between both the groups.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • diagnosed with maxillofacial injuries requiring surgical fixation under general anaesthesia.

排除标准

  • Head injuries Polytrauma Scheduled for multiple surgeries A diagnosed Psychiatric illness Already intubated or tracheostomised Refusal to provide consent.

结局指标

主要结局

Length of hospital stay

时间窗: at the time of discharge

次要结局

  • Quality of Recovery using QoR-15 scale(24 hours postoperatively, 48 hours postoperatively, at discharge)
  • Patient satisfaction at discharge using 5 level likert scale(at discharge)
  • Perioperative opioid use(From day of admission to day of discharge)
  • Compications, if any, including airway obstruction, aspiration, difficult intubation/extubation, intraoperative bleeding, local anaesthesia toxicity, postoperative infection, surgical hardware failure or instability.(from day of admission to day of discahrge)

研究者

发起方
Department of Anaesthesia and Intensive care
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Vidyashree G S

Post Graduate Institute Of Medical Education and Research

研究点 (1)

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