跳至主要内容
临床试验/CTRI/2022/07/044423
CTRI/2022/07/044423尚未招募不适用

Comparison of efficacy of ultrasound guided thoracic paravertebral block (TPVB) with combined pectoral nerve block (PEC) and pecto-intercostal fascial block (PICF) for perioperative analgesia in modified radical mastectomy: a randomised control trial

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年1月8日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Time for first rescue analgesia noted in minutes/hours

研究概览

简要总结

Breast cancer is the most frequent cancer among Indian women accounting for 25 to 32 per cent. Surgical resection of the primary tumour with axillary dissection is one of the most important therapeutic procedures for breast cancer. Most breast surgeries are done in general anaesthesia, with or without regional blocks. Forty per cent of women experience moderate to severe pain following breast cancer surgery in the first few days.

Various regional anaesthesia techniques including thoracic paravertebral block, Erector spinae plane block, PEC block etc. have been used for perioperative analgesia in breast cancer surgery to decrease opioid consumption and its side effect. Poor management of acute postoperative pain may lead to persistent postoperative pain with an incidence of 25 to 60% of patients. These blocks are found to be effective for postoperative analgesia and also decrease the incidence of post-mastectomy pain syndrome. The paravertebral block is considered the gold standard for breast surgery but this block is associated with many complications. Recently interfacial blocks (pectoral nerve blocks) have been used for post-op analgesia in breast surgery.

This study aims to compare the efficacy of ultrasound-guided combined pectoral nerve block and pecto intercostal fascial block with thoracic paravertebral block for perioperative analgesia for MRM, and to find which requires less opioid consumption, better NRS, fewer complications, a better patient satisfactory score.

研究设计

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

入排标准

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

入选标准

  • Adult aged between 30-70 Yrs.
  • Posted for unilateral MRM 3.

排除标准

  • Patients refusal
  • Sensitivity to LA
  • Bleeding disorders
  • patients on anticoagulants
  • BMI of more than 35 kg/m2
  • Spine/chest wall deformity
  • Pregnancy
  • Inability to understand NRS and PCA device use
  • Current chronic opioids use.

结局指标

主要结局

Time for first rescue analgesia noted in minutes/hours

时间窗: Not applicable

次要结局

  • Total opioid consumption(first 24 hour)
  • Postoperative morphine consumption in the first 24 hours(End of post operative 24 hour)
  • Post-operative NRS on rest and movement(0,1,2,4,6,12,24 hour post surgery)
  • Complication(Patient satisfactory score)

研究者

申办方类型
Government medical college

研究点 (1)

Loading locations...

相似试验