跳至主要内容
临床试验/CTRI/2016/06/007047
CTRI/2016/06/007047已完成2/3 期

ultrasound guided paravertebral, pectoralis II and serratus anterior plane block in breast surgeries: spread of local anesthetic and post operative analgesia

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2016年1月7日最近更新:

试验速览

阶段
2/3 期
状态
已完成
入组人数
45
试验地点
1
主要终点
1.Find out the spread of local anesthetic radiographically and co-relate it with the sensory blockade produced.

研究概览

简要总结

Breast surgeries are associated with significant post operative pain which may progress to chronic pain. Regional techniques reduce the postoperative acute pain which results in reduced morbidity and decreased consumption of opioids. Paravertebral block is commonly used for breast surgeries. However it is associated with many complications.

Two new ultrasound guided interfascial plane blocks-PECS II and serratus plane block have been recently described which are more selective, have less complications and may provide better analgesia.

There are no studies comparing these blocks for breast surgery. Also, evaluating the area of sensory blockade in large number of patients will help in describing the extent of blockade more accurately and their use may extend beyond breast surgeries. This study is designed to study about these new techniques under ultrasound guidance to ensure maximum safety and find their analgesic efficacy.

Therefore, we hypothesize that

·         PECS II and serratus plane block will provide better analgesia than paravertebral block for breast surgeries with lesser side effects.

·         Serratus plane block will provide better sensory blockade and analgesia than PECS II block.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

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

入选标准

  • ASA 1 and 2 undergoing elective mastectomy surgeries.

排除标准

  • coagulopathy BMI >35kg/m2 pregnancy mental retardation chest wall deformity.

结局指标

主要结局

1.Find out the spread of local anesthetic radiographically and co-relate it with the sensory blockade produced.

时间窗: 1.radiographic spread seen immediately after injecting the drug. sensory block seen 15-30 minutes after injecting the drug | 2.total fentalyl consumption seen at 24 hours after the surgery

2.To compare the post operative 24 hour fentanyl consumption.

时间窗: 1.radiographic spread seen immediately after injecting the drug. sensory block seen 15-30 minutes after injecting the drug | 2.total fentalyl consumption seen at 24 hours after the surgery

次要结局

  • •Onset of sensory blockade(•Intra-operative opioid requirement)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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