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临床试验/CTRI/2024/07/070893
CTRI/2024/07/070893招募中2 期

To assess the effect of type and incidence of morbidity on length of hospital stay between different anaesthesia technique following damage control orthopaedic surgery

not applicable1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2024年7月31日最近更新:

试验速览

阶段
2 期
状态
招募中
入组人数
126
试验地点
1
主要终点
To compare the incidence and type of early morbidity between general versus regional anaesthesia technique assessed by POMS score at post-operative day (POD) 8 following emergency orthopaedic surgery

研究概览

简要总结

This study is an RCT to compare the incidence and type of early morbidity between general versus regional anaesthesia technique assessed by POMS score at post-operative day (POD) 8 following emergency orthopaedic surgery that will be conducted in the Department of Anaesthesia & Intensive Care, PGIMER, Chandigarh in patients who had traumatic lower limb open fractures type IIIA and IIIB undergoing emergency orthopaedic surgery. Patients fulfilling the inclusion criteria will be recruited. Basic demographic data, ASA PS grade, Acute Physiology and Chronic Health Evaluation (APACHE) score, nature of injury, Injury Severity Score (ISS), site, duration and type of surgery, time since injury, co-morbidities, routine baseline investigations, including renal function test (RFT) and coagulation profile shall be recorded. Anaesthesia provider will not be blinded to the intervention. Patients will be randomly assigned to two groups in a 1:1 ratio using a computer-generated randomised list concealed by opaque sealed envelopes. The outcome assessor, data analyst will remain blinded. Postoperative morbidity will be measured by using Post Operative Morbidity Survey (POMS) score. For comparing POMS, each patient’s score will be recorded prospectively in the post-operative period at the following time points. T1- 1st Post operative Day (POD1), T2-POD3, T3-POD5, T4-POD8.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients of ASA grade 1&2 between ages 18 to 60 years of either gender with open lower extremity fractures IIIa, and IIIb, of the one or both lower limbs being taken up for emergency surgery within 24 hours of injury and 12 hours of hospital admission.

排除标准

  • patients with uncontrolled comorbid conditions, upper limb fracture, hemodynamically unstable patients, vascular injury, pregnancy, pelvic thoracic and abdominal trauma, patient refusal.

结局指标

主要结局

To compare the incidence and type of early morbidity between general versus regional anaesthesia technique assessed by POMS score at post-operative day (POD) 8 following emergency orthopaedic surgery

时间窗: POD8

次要结局

  • To compare the trends in POMS score between anaesthesia techniques on POD 1,3,5 and 8(POD 1,3,5 and 8)

研究者

申办方类型
Other [not applicable]
责任方
Principal Investigator
主要研究者

Dr.A.Swathy

Postgraduate Institute of Medical Education and Research

研究点 (1)

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