Effectiveness of Serratus Anterior Muscle Plane Block With Thoracic Paravertebral Block For Unilateral Mastectomies
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Efficacy of SPB block vs thoracic PVB
研究概览
简要总结
HYPOTHESIS
Serratus Anterior Muscle Plane Block (SPB) is as effective as thoracic paravertebral block (PVB) for acute pain control after unilateral mastectomies.
SPECIFIC AIMS
Primary aim: To evaluate the efficacy of SPB block vs thoracic PVB for acute pain control in patients undergoing unilateral mastectomy
Secondary aim To compare the onset and duration of block and dermatomes blocked in both groups To compare the need of post-operative rescue analgesia in both groups. To compare the development of chronic incisional pain in both groups Functional outcome with respect to daily activities.
详细描述
RESEARCH STRATEGY
- Background
Breast cancer is a potentially deadly disease affecting one in eight women. [1] Majority of them undergo mastectomies along with different modalities of treatment like chemotherapy, radiotherapy and hormonal treatments.
Since mastectomy is the main and most commonly preferred treatment for breast cancer surgery, it raises the focus on the most frequently studied complication that is persistent pain following surgery [8, 9] The incidence of pain syndrome six months post-breast cancer surgical treatment was 52.9%.[7] A multivariate analysis of the presence of chronic pain in breast cancer survivors revealed risk factors including more invasive surgery, radiation therapy after surgery, and clinically meaningful acute postoperative pain. Each risk factor independently predicted more intense chronic pain at three months after surgery. [8] A 20% prevalence rate of the Post Mastectomy Pain syndrome was found. Women experiencing the syndrome reported chronic, stable pain of long duration that began shortly after surgery. [10] The syndrome is important to recognize because of how debilitating the pain can be. Studies have indicated that post mastectomy pain interferes with activities of daily living like driving, taking care of the children, leisure time, and sex, all of which result in poor quality of life. It was also noted that in women who survived treatment of breast cancer, chronic pain often caused mood changes, difficulty at work, and reduction of physical activities. This was especially noted in those women whose pain spreads to other areas of the body. [14]
There are various anesthetic techniques available for management of mastectomies. The effectiveness of each technique is widely studied regarding pain control, requirement of rescue analgesia, side effects, post-operative hospital stay and development of persistent pain following breast cancer surgical treatment. Belzarena SD et al compared the effectiveness of thoracic epidural block and general anesthesia for oncologic mastectomy. Patients were divided in two groups in which they either received GA or thoracic epidural anesthesia as primary anesthetic. [10] The results showed that the quality of postoperative analgesia was better in the epidural group, which also presented with lower consumption of analgesics. The length hospitalization in this group was also lower. They concluded that an epidural block had some advantages when compared with general anesthesia and can be considered an anesthesia option in oncologic mastectomies with axillary lymph node dissection.
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
- Single (Outcomes Assessor)
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
- •Simple or radical unilateral mastectomy with or without axillary lymph node dissection.
- •American Society of Anesthesia (ASA) I, II and III
排除标准
- •Morbid obesity (body mass index > 40 kg/m2);
- •Renal insufficiency (creatinine > 2.0 mg/DL),
- •Current chronic analgesic therapy (daily use > 4 weeks),
- •History of opioid dependence, pregnancy.
- •Allergy to local anesthetic
- •Rash/infection at the area of injection
- •Coagulation disorder
- •Patients on anticoagulation
研究组 & 干预措施
Serratus Anterior Muscle Plane Block
The US probe will be placed in the mid-axillary line at the level of the 5th intercostal space. The latissimus dorsi, teres major and serratus muscles will be identified. Using in-plane approach, the block needle (22 G, 50 mm) will be inserted until the tip is visualized between the serratus anterior muscle and the intercostal muscles. As an extra reference point thoracodorsal artery will be used which aids in the identification of the plane superficial to the serratus muscle. After negative aspiration of blood, local anesthetic (20 ml of 0.25 % bupivacaine) will be injected and visualized in real-time.
干预措施: Bupivacaine (Drug)
Thoracic Paravertebral Block
The spinous processes of T1- T5 will be identified and at parasagittal plan at 2.5 cm, skin wheel will be raised using 1% lidocaine. A 20-gauge, bevel needle will be advanced until the transverse process is located. The depth from skin to transverse process will be marked/identified by needle marking. The needle will be withdrawn 1-2 cm and angled down.The needle will be re-advanced 1cm past the initial marking. After negative aspiration, 4-5 ml of 0.25% bupivacaine will be slowly injected. The same procedure will be repeated at each level from T2 to T6 ensuring total dose of bupivacaine does not exceed the maximum dose recommended.
干预措施: Lidocaine (Drug)
Thoracic Paravertebral Block
The spinous processes of T1- T5 will be identified and at parasagittal plan at 2.5 cm, skin wheel will be raised using 1% lidocaine. A 20-gauge, bevel needle will be advanced until the transverse process is located. The depth from skin to transverse process will be marked/identified by needle marking. The needle will be withdrawn 1-2 cm and angled down.The needle will be re-advanced 1cm past the initial marking. After negative aspiration, 4-5 ml of 0.25% bupivacaine will be slowly injected. The same procedure will be repeated at each level from T2 to T6 ensuring total dose of bupivacaine does not exceed the maximum dose recommended.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Efficacy of SPB block vs thoracic PVB
时间窗: 6 months
Efficacy of SPB block vs thoracic PVB block as described by reduce post operative pain score and reduce requirement for Narcotics.
次要结局
- Development of chronic incisional pain(24 and 48 hours)
- Post-operative rescue analgesia(up to 24 hours)
- Pain related assessment scores as described in the Pain Detect Questionnaire(6 months)
- Onset and duration of block(6 months)
研究者
Sara R Guzman-Reyes
Associate Professor
The University of Texas Health Science Center, Houston
