Analgesic Effect of Adding Thoracic Paravertebral Nerve Blocks to Modified PEC Block in Breast Cancer Surgery, Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Postoperative fentanyl consumption
研究概览
简要总结
To compare efficacy and safety of adding thoracic paravertebral nerve blocks to modified PEC block versus modified PEC block only in breast cancer surgery. This study evaluate systemic opioid requirement in 48 hours in primary outcome and the analgesic profile ( pain score at rest and on shoulder movement), opioid-related side effects and nerve blocks complications.
详细描述
Regional anesthesia has been used and studied extensively in breast surgery as an opioid-sparing strategy, with block of the intercostal supply by thoracic paravertebral block (TPVB) becoming a popular technique.
This prospective randomized controlled trial is aimed to study the proper regional nerve block technique to reach the postoperative opioid-free requirement modality for breast cancer surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Randomized group of patient is identified and sealed in envelope. There is not written group in anesthetic record. Postoperative outcomes are assessed by Acute Pain Service nurse or a resident (co-investigator who blinds to the technique).
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) grade I-III
- •Aged ≥ 18-80 years old
- •Elective unilateral total mastectomy with sentinel lymph node biopsy or lymph node dissection
排除标准
- •Patient refusal
- •Language barrier or inability to communicate with the operating team
- •Allergy to local anesthetic
- •Bleeding disorder
- •Previous breast surgery or thoracic radiation therapy
- •Patient who can not understand the proper use of intravenous patient-controlled analgesia machine or who has the problem with communication
- •Chronic pain patient
结局指标
主要结局
Postoperative fentanyl consumption
时间窗: at postoperative 48 hours
Cumulative fentanyl consumption within postoperative 24-48 hours
次要结局
- Intraoperative fentanyl use(Intraoperation)
- Percentage of patients presenting with opioid-related adverse effects(Within 48 hours)
- Cost effectiveness analysis(Within 48 hours)
- Postoperative pain score at rest(Postoperative 24 hour (at ward))
- First time to fentanyl requirement by IV PCA(Within 24 hours)
- Length of hospital stay(From preoperative admission until hospital discharge)
- Percentage of patients presenting with nerve block complications(Within 48 hours)
- Postoperative pain score on shoulder movement(Postoperative second day (at ward))
- Patient's satisfaction scale score(At postoperative 48 hours)
研究者
Suwimon Tangwiwat
Assistant professor, Department of Anesthesiology
Mahidol University