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临床试验/CTRI/2025/05/087847
CTRI/2025/05/087847尚未招募不适用

Comparison of patient satisfaction with thoracic segmental spinal anaesthesia with modified tumescent solution vs general anaesthesia with standard tumescent solution for liporeduction of gynecomastia: A Randomized controlled trial

Dr. Sandeep Garee1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
1. To compare the patient satisfaction of using SSA vs GA in patients undergoing liporeduction for gynecomastia surgeries.

研究概览

简要总结

Gynecomastiais a most common condition affecting male breast due to enlargement of bothductal and stromal tissue. Corrective surgery is the only solution for longstanding gynecomastia, and it includes open excision, conventional liposuction,or combination of these if required under local (tumescent) or generalanaesthesia. Segmental spinal anaesthesia (SSA) to block only the thoracicsegments can also be given for breast surgeries and there are numerousadvantages such as Avoidance of airway manipulation, polypharmacy, lesser risk ofPONV, lesser chances of hypotension, able to achieve adequate muscle relaxationwithout respiratory or circulatory depression. Using modified tumescentsolution (removing lignocaine and bupivacaine) we can eliminate the possibilityof Local anaesthesia systemic toxicity (LAST) while analgesia will be providedby SSA. Our Primary objective is to compare the patient satisfaction of usingSSA vs GA in patients undergoing liporeduction for gynecomastia surgeries andour secondary Objectives are to assess and compare the surgeon satisfaction ofusing SSA vs GA in patients undergoing liporeduction for gynecomastia surgeries,to compare the incidence of PONV among both the groups and to compare theincidence of hemodynamic variations among the groups. This is a pilot study, where we want tofind the feasibility of using the modified tumescent solution. We will include20 patients in SSA and 20 patients in GA group. Hence, we would like tocompare patient satisfaction with thoracic segmental spinal Anaesthesia usingmodified tumescent solution vs General Anaesthesia using standard tumescentsolution for liporeduction of gynecomastia.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
1.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •1.Patients coming for gynecomastia surgeries.

排除标准

  • •1.Allergy to local anaesthetics 2.Contraindications to spinal anesthesia 3.Cardiac abnormalities (Mitral and Aortic stenosis, CAD etc)
  • •ASA 3,4 and 5 5.Patients refusal.

结局指标

主要结局

1. To compare the patient satisfaction of using SSA vs GA in patients undergoing liporeduction for gynecomastia surgeries.

时间窗: 4 hours , 8 hours , 12 hours and 24 hours after the intervention

2. To study the time to first rescue analgesia between segmental spinal anaesthesia vs GA for liporeduction in gynecomastia surgeries.

时间窗: 4 hours , 8 hours , 12 hours and 24 hours after the intervention

次要结局

  • 3.To compare the incidence of hemodynamic variations among the groups(Every 5 min until end of Surgery & then every 15 min for next 3 hours.)
  • 1.To assess & compare the surgeon satisfaction of using SSA vs GA in patients undergoing liporeduction for gynecomastia surgeries(Immediately after the surgery)
  • 2.To compare the incidence of PONV among both the groups(24 hours)

研究者

发起方
Dr. Sandeep Garee
申办方类型
Research institution and hospital

研究点 (1)

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