跳至主要内容
临床试验/CTRI/2024/05/066859
CTRI/2024/05/066859尚未招募不适用

Segmental thoracic spinal anesthesia versus general anesthesia for breast cancer surgery – a prospective randomized comparative study.

Ruchi Sxaena1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年5月13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
70
试验地点
1
主要终点
1. Patient satisfaction score

研究概览

简要总结

General anesthesia (GA) is considered to be the standard technique for breast cancer surgery. However, the associated higher stress response, higher incidence of nausea, vomiting and increasing length of hospitalization demand for an alternative technique. Regional anesthesia techniques can attenuate surgical stress response and provide superior analgesia, with higher patient satisfaction and lesser incidence of nausea, vomiting and reduction in postoperative opioid consumption. Since, patients have motor control over the legs, which decrease anxiety and exhibit a high level of satisfaction. Additionally, direct protective action of local anesthetics on cancer cell migration is also been observed. Also, it can have a long-term effect in decreasing complications such as chronic pain.

Few studies have assessed the efficacy of segmental thoracic spinal anesthesia (STSA) in laparoscopic cholecystectomy and breast cancer surgery with axillary lymph node clearance concluding that the technique could be a potential alternative to GA. So, we decided to study STSA as the sole regional anesthetic technique and to compare it with GA for breast cancer surgery.

We hypothesized that STSA could be a potential alternative to GA in patients undergoing breast cancer surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status I-II patients.
  • Aged 20-65 years Patients with primary breast cancer scheduled for unilateral mastectomy with axillary dissection.

排除标准

  • Patient refusal,
  • Conditions contraindicating spinal anesthesia,
  • Inflammatory breast cancer,
  • Body mass index above 35kg/m2
  • Patients undergoing MRM with flap reconstruction.

结局指标

主要结局

1. Patient satisfaction score

时间窗: 24 hours

次要结局

  • 1. Intraoperative hemodynamic changes.(2. Pain score at 1h, 4h,8h and 24 h after surgery.)

研究者

发起方
Ruchi Sxaena
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Ruchi Saxena

Kalyan Singh Superspeciality Cancer Institute

研究点 (1)

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