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临床试验/CTRI/2025/03/081983
CTRI/2025/03/081983招募中不适用

A Pragmatic Randomized Controlled Study on the Efficacy of Intravenous versus Peri-tumoral Lignocaine Administration in Attenuating Pro- metastatic Biomarkers in Breast Cancer Patients undergoing Resection: a Step Towards Reducing recurrence

Dr Zainab Ahmad1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2025年3月20日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
105
试验地点
1
主要终点
Serum levels of prometastatic biomarkers - NETosis biomarkers - (H3Cit and MPO)

研究概览

简要总结

This randomized controlled trial will be conducted at the All India Institute of Medical Sciences (AIIMS) Bhopal, involving departments of anesthesiology, biochemistry, surgery, oncosurgery and translational Medicine. The study will include three parallel arms: IV lignocaine infusion, peri-tumoral lignocaine infiltration, and a control group. A total of 105 patients will be enrolled, with 35 patients in each group. Block randomization will ensure balanced distribution across tumour subtypes. The IV lignocaine group will receive a weight based lignocaine bolus 10 minutes prior to incision followed by continuous infusion until skin closure, while the peri-tumoral group will receive a similar bolus injected around the tumor 10 minutes prior to incision. The control group will receive normal saline. All the groups will also receive evidence based standardised surgical and anesthesia care as defined in the study protocol. Biomarker levels will be measured using commercial ELISA kits, and patients will be followed for at least two years for cancer recurrence.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

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 physical status I- to II, with operable breast cancer Stage I to III.

排除标准

  • Metastatic or recurrent breast cancer, significant comorbidities, contraindications to lignocaine, pregnancy, weight less than 40 kg, preoperative hypotension, immune disorders, or long-term immunosuppressive drug use.

结局指标

主要结局

Serum levels of prometastatic biomarkers - NETosis biomarkers - (H3Cit and MPO)

时间窗: Baseline and at 24 hours after surgery

次要结局

  • Early cancer recurrence(2 years or until the end of the study)
  • Angiogenesis Biomarkers - MMP 3, VEGF(baseline and at 24 hours after surgery.)
  • Changes in arrays of metabolomic profile and hypoxia inducible factors (HIF)(baseline and at 24 hours after surgery.)

研究者

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

Dr Zainab Ahmad

All India Institute of Medical Sciences (AIIMS), Bhopal

研究点 (1)

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