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临床试验/NCT04343807
NCT04343807已完成不适用

Effectiveness of Ultrasound Guided PECS Block on Opioid Consumption and Patient Satisfaction Through Adequate Pain Control Following Breast Cancer Surgery. A Prospective Randomized Controlled Trial

Aga Khan University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Total intraoperative opioid consumption

研究概览

简要总结

Breast cancer is the most common and leading cause of cancer deaths among females worldwide. Patients undergoing modified radical mastectomy (MRM) are associated with moderate to severe acute postoperative pain and shoulder mobility restriction.

This study aims to determine the effectiveness of ultrasound-guided PECS block for reducing opioid consumption, providing adequate postoperative pain management and improving patient satisfaction following breast cancer surgery.

详细描述

The traditional pain management for patients undergoing MRM has relied heavily on opioids but a number of multimodal pain control strategies also exist including combining opioids with NSAIDs, cyclooxygenase-2 inhibitors, acetaminophen and regional blocks. Recently, literature underlines the importance of performing regional anaesthetic and analgesic techniques for postoperative analgesia following breast surgery. PECS (Pectoral nerve block) block provides analgesia for breast surgeries with few adverse effects.

OBJECTIVES To evaluate the effect of ultrasound guided pectoral block in reducing intraoperative and postoperative opioid consumption following modified radical mastectomy.

The secondary objective is to determine patient satisfaction levels associated with adequate pain control.

HYPOTHESIS Pectoral nerve blocks provides superior analgesia with less opioid consumption and improves patient satisfaction in postoperative period compared to conventional pain management for modified radical mastectomy patients

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients undergoing elective modified radical mastectomy (MRM)
  • All adults aged between 18 and 65 years
  • ASA (American Society of Anesthesiologists ) I & II

排除标准

  • Patient refusal
  • Hypersensitivity to local anaesthetics
  • Coagulopathy or bleeding diathesis
  • Local infection at the site of block
  • BMI more than 35 kg/m2
  • Chest wall deformity or previous breast surgery
  • MRM with latissimus dorsi or deep inferior epigastric perforator flap reconstruction

结局指标

主要结局

Total intraoperative opioid consumption

时间窗: During surgical procedure

Total intraoperative nalbuphine

Total postoperative opioid consumption

时间窗: First 24 hours after surgery

Total Rescue Tramadol Consumption

次要结局

  • Patient Satisfaction(First 24 hours after surgery)
  • Postoperative pain score(1, 6,12 and 24 hours after surgery)
  • Postoperative nausea and vomiting(First 24 hours after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Faisal Shamim

Associate Professor Anaesthesiology

Aga Khan University

研究点 (1)

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