Contribution of Transversus Thoracis Plane Block in Combination With Serratus Anterior Plane Block to the Quality of Recovery After Breast Cancer Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Quality of recovery-15 (QoR-15) score
研究概览
简要总结
Breast cancer is the most common malignancy in women worldwide. Even minor breast surgery can cause significant postoperative pain (PP). PP can turn into chronic pain in 25-40% of cases. Inadequate PP control is associated with increased morbidity, delayed wound healing, prolonged hospital stay, increased opioid use and side effects, and high cost of care.
Opioid use remains the mainstay of postoperative analgesia. Opioids, especially morphine, inhibit both cellular and humoral immune functions. This effect may be responsible for the high rates of local recurrence and/or metastasis after surgery. Additionally, studies have shown that perioperative opioid use is associated with social abuse. This demonstrates the importance of reducing perioperative opioid use. Currently, multimodal analgesia based on nerve block is being widely investigated and has shown encouraging clinical results.
Numerous regional analgesic techniques have been investigated in breast cancer surgery, including intercostal nerve block, thoracic epidural anesthesia, and paravertebral block. Compared with general anesthesia alone, it reduces the postoperative pain score even after a single-shot injection for up to 72 hours, reduces opioid consumption, improves the quality of patient recovery, and suppresses the development or reduces the severity of chronic pain.
Serratus anterior plane block (SAPB) is reported to be effective in perioperative pain management of breast cancer surgeries. The important problem of SAPB block is that it is insufficient to block the anterior cutaneous branches of the intercostal nerves. Therefore, intravenous analgesia is required. Thoracic transversus muscle plane block (TTPB) is a recently described fascial plane block used to anesthetize the anterior cutaneous branches of the intercostal nerves from T2-T6. Its effectiveness has been demonstrated for breast surgery and median sternotomy.
In our study, we will provide postoperative analgesia in patients undergoing breast surgery by applying the serratus anterior block in combination with the transversus thoracis plane block. Since we avoid complicated analgesia methods such as paravertebral block, the risk of complications will be reduced.
In this study, we aimed to compare the effectiveness of the combination of SAPB and TTPB with SAPB performed alone in 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, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •ASA I-II-III
- •BMI 20 to 35 kg / m2
- •Patients scheduled for breast cancer surgery procedure
排除标准
- •Patients with previously known allergies to the drugs to be used in the study,
- •Infection near the puncture site,
- •Patients with previous symptoms of neurological disease (TIA, syncope, dementia, etc.)
- •Known coagulation disorders,
- •Alcohol and drug use,
- •Disorder of consciousness,
- •Opioid use equal to or greater than 60 mg oral morphine equivalent per day,
- •Patients with pre-existing neuropathic pain,
- •Liver failure, renal failure, cardiac failure
- •Morbid obesity (body mass index [BMI] > 35 kg m-2)
- •Uncontrolled diabetes mellitus
- •Women during pregnancy or breastfeeding
- •Not approving the informed consent form
结局指标
主要结局
Quality of recovery-15 (QoR-15) score
时间窗: at the end of 24 hours postoperatively
Quality of recovery-15 (QoR-15) score at 24 hours after surgery
次要结局
- Postoperative opioid consumption(up to the first 24 hours postoperatively)
- Pain intensity score(0, 2, 6, 12, 24 hours postoperatively.)
- Patient satisfaction(at the end of 24 hours postoperatively)
- Postoperative nausea and vomiting(up to the first 24 hours postoperatively)
研究者
Aylin Ceren Sanli
Asist Dr
Bezmialem Vakif University