跳至主要内容
临床试验/CTRI/2024/05/067275
CTRI/2024/05/067275尚未招募不适用

COMPARING THE EFFICACY OF ULTRASOUND-GUIDED PECTORAL NERVE BLOCK VERSUS THORACIC EPIDURAL BLOCK USING ROPIVACAINE FOR POSTOPERATIVE ANALGESIA AFTER MODIFIED RADICAL MASTECTOMY A RANDOMISED CONTROLLED TRIAL

Dr G Vignesh1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年5月23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
64
试验地点
1
主要终点
To Compare the efficacy of post operative analgesia of ropivacaine in two groups.

研究概览

简要总结

To compare the better analgesic efficacy of two groups i.e., ropivacaine (0.2%) for post operative pain relief in patient undergoing modified radical mastectomy (Ultrasound guided pectoral nerve block vs thoracic epidural block)

In this study, two groups

T group(thoracic epidural block) patient were received a single shot of 15ml of 0.2% ropivacaine between t4 and t5 vertebrae.

PECS(p group)The pectoral nerve (PecS II) block, which was first described by Blanco et al.,is a relatively new, less-invasive technique of postoperative analgesia and is devoid of major side effects. The Pecs II block is an interfascial plane block, where Ropivacaine 0.2%-10ml is deposited into the plane between the pectoralis major muscle (PMm) and the pectoralis minor muscle (Pmm) (PecS I block) and Ropivacaine 0.2%-15ml is injected between Pmm and the serratus anterior muscle at the third rib (Pecs II block). This novel technique also blocks long thoracic and thoracodorsal nerves, lateral and medial pectoral nerves along with lateral branches of intercostal nerves, exiting at the level of mid-axillary line to innervate the breast and the skin innervate from T2 to T6, thus providing good analgesia for mastectomy and axillary clearance.

Assessment of post operative pain in both groups will be done using VAS (Visual Analogue Scale) score 1-10 at 30min, 4hrs, 8hrs,12 hrs,20 hrs and 24hrs after surgery and the data will be recorded in both groups.

If a VAS score of 4 is reported rescue analgesia will be given at that time using Inj.Tramadol 50mg iv and the frequency of the rescue analgesics will also be noted for both the groups. Side effects of ropivacaine-nausea and vomiting.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator 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 with ASA classification I & II Age of above 18 to 60 yrs Posted for Modified radical mastectomy.

排除标准

  • Patient not willing to participate History of Spine pathology or spine surgeries Patient with infection at the block site Coagulopathy Morbid obesity Allergy to LA agent.

结局指标

主要结局

To Compare the efficacy of post operative analgesia of ropivacaine in two groups.

时间窗: To Compare the efficacy of post operative analgesia of ropivacaine in two groups at 30mins,4hrs,8hrs,12hrs,20hrs, | 24hrs and their analgesic duration

次要结局

  • Number of rescue analgesia(4hrs,8hrs,12hrs,20hrs,)

研究者

发起方
Dr G Vignesh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr G Vignesh

Karpaga Vinayaga Institute Of Medical Sciences and Research Centre

研究点 (1)

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