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临床试验/CTRI/2021/12/038627
CTRI/2021/12/038627已完成不适用

Comparison Of Efficacy Of Ultrasound Guided Single Level Thoracic Paravertebral Block VersusComplete Antethoracic Block For Postoperative Analgesia In Modified Radical Mastectomy:A Non Inferiority Randomized Controlled Trial

AIIMS1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年12月16日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
AIIMS
入组人数
70
试验地点
1
主要终点
To measure the duration of Post-operative

研究概览

简要总结

Breast cancer is increasingly becoming the most common cancer among females worldwide.Modified radical mastectomy(MRM) is a common surgical procedure being performed for patients with breast cancer.Perioperative pain management is one of the crucial elements required for optimal outcome of patients undergoing oncosurgical procedures.The optimal use of analgesic technique provides both short term benefits like adequate pain management,reduced postoperative nausea and vomiting,improved quality of surgical recovery and long term benefits like reduced risk of development of chronic postsurgical pain and development of metastases and recurrent disease.A number of regional anesthetic techniques like local wound infiltration,thoracic epidural anesthesia and thoracic paravertebral block and more recently fascial blocks have been employed for perioperative pain in patients undergoing breast cancer surgeries.The fascial blocks include classical and modified Pectoralis nerve block(PECS),Serratus anterior plane(SAP) and Erector spinae plane block(ESPB).The pectoral nerve block is an easy and safe nerve block for breast surgery.But it does not sufficiently block the anterior branches of the intercostal nerves (from T2 to T6) or the lateral branches of the intercostal nerves (from T5 to T6); therefore, postoperative analgesia of the internal and inferior mammary area may be insufficient. Complete Antethoracic block blocks these spared anterior and lateral branches of intercostal nerves too,hence better analgesia of the breast is provided.There is a case report on analgesic effect of complete antethoracic block,but it has not been compared with paravertebral block to compare its analgesic efficacy previously.Hence,with the above background, we planned a prospective randomized clinical trial to compare the analgesic efficacy of single level thoracic paravertebral block and complete antethoracic block in patients undergoing modified radical mastectomy.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
Female

入选标准

  • ASA I and II
  • Patients posted for MRM
  • Patients giving written informed consent to participate in the study.

排除标准

  • BMI > 35kg/m2
  • Patient with infection at the site of injection
  • Coagulopathy
  • Spine deformity
  • Drug addicts or history of opioid dependence
  • Patients with history of allergy to opioids or local anaesthetics.

结局指标

主要结局

To measure the duration of Post-operative

时间窗: Post-operative (0 | min) ,30 min ,1, 2 , 6 ,12 and 24 hours or as per patients request within 24hours in postoperative period

analgesia (that is, time to first rescue analgesia

时间窗: Post-operative (0 | min) ,30 min ,1, 2 , 6 ,12 and 24 hours or as per patients request within 24hours in postoperative period

after administration of block ).

时间窗: Post-operative (0 | min) ,30 min ,1, 2 , 6 ,12 and 24 hours or as per patients request within 24hours in postoperative period

次要结局

  • Total rescue analgesic requirement in(Post-operative period.)
  • Comparison of Post-operative pain ( using numeric rating scale) and adverse effects(Post-operative (0)
  • To evaluate and compare patient satisfaction with the block(procedure and at the end of 24hours in postoperative period.)

研究者

发起方
AIIMS
申办方类型
Government medical college

研究点 (1)

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