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临床试验/CTRI/2023/06/053769
CTRI/2023/06/053769尚未招募2/3 期

Comparative study of ultrasound guided erector spinae block versus paravertebral block in post operative analgesia after breast cancer surgeries

Dr JP Attri1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年6月28日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1. Procedural time (time required to complete the block)

研究概览

简要总结

Breast cancer is one of the common malignancies among women.

Surgical resection of the primary tumor with axillary dissection is one of the main modalities of breast cancer treatment mostly done under general anaesthesia with or without regional blocks. The present study aims to compare the efficacy of ultrasound guided paravertebral block with erector spinae block for postoperative analgesia in breast cancer surgeries in Government Medical College and Hospital, Amritsar. 60 female patients of age between 20-60 years and ASA grade I and II will be randomly divided into two groups of 30 patients, each receiving erector spinae block and paravertebral block using ultrasound guidance. The procedural time, duration of sensory block, consumption of fentanyl during 24 hours, time to rescue analgesia and total dose of rescue analgesia will be assessed in both groups. Haemodynamics will be assessed. Intraoperative and postoperative complications will also be noted. The data thus obtained will be analyzed and compared statistically.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • Patients aged 20 –60 years American Society of Anesthesiologists (ASA) I or II Patients with normal neurological status Co-operative patients Patients undergoing breast cancer surgeries.

排除标准

  • Refusal of patient for the procedure or to enlist in study Patients of American Society of Anaesthesiologists (ASA) Grade III and IV Uncooperative patients Patients with clinically significant pulmonary pathology Pregnant females Patients with coagulation disorders and on anticoagulation therapy Patient with history of allergy to local anaesthetic Known neuropathies.

结局指标

主要结局

1. Procedural time (time required to complete the block)

时间窗: Baseline followed by every 30 minutes till 2 hours followed by every 2 hour till 8 hours followed by every 6 hours till 24 hours

2. Duration of sensory block

时间窗: Baseline followed by every 30 minutes till 2 hours followed by every 2 hour till 8 hours followed by every 6 hours till 24 hours

3. Time to first rescue analgesia

时间窗: Baseline followed by every 30 minutes till 2 hours followed by every 2 hour till 8 hours followed by every 6 hours till 24 hours

4. Total dose of rescue analgesia in 24 hours

时间窗: Baseline followed by every 30 minutes till 2 hours followed by every 2 hour till 8 hours followed by every 6 hours till 24 hours

次要结局

  • 1. Haemodynamic changes(2. Side effects and complications)

研究者

发起方
Dr JP Attri
申办方类型
Other [self]

研究点 (1)

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