Analgesic Efficacy of Ultrasound-guided Retrolaminar Block and Erector Spinae Plane Block in Modified Radical Mastectomy: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- the total morphine consumed postoperatively for 24 hours
研究概览
简要总结
Modified radical mastectomy (MRM) is the most commonly performed surgical procedure in breast cancer patients and is usually associated with severe postoperative pain. The peripheral nerve block techniques were suggested to reduce acuter post-mastectomy pain. The study compared the analgesic efficacy of retrolaminar block (RLB) and ESPB in patients undergoing MRM.
详细描述
Introduction Globally, breast cancer remains the most prevalent cancer among females, with an estimated incidence of 31% and mortality of 15%. Surgery is foremost in managing breast cancer, where modified radical mastectomy (MRM) is the most commonly performed procedure. This procedure implicates vigorous tissue dissection and seroma formation with many postoperative complications. Pain is the main complaint following MRM, affecting up to 50% of women, and 25-60% develop persistent chronic postmastectomy pain.
Therefore, adequate pain control is crucial to postoperative management after MRM. Numerous analgesic methods were suggested to reduce acuter post-mastectomy pain. Opioid-related adverse events include nausea and vomiting, respiratory depression, sedation, and dizziness.
Most mastectomy-related pain originates from the chest wall's sensory nerves. The peripheral nerve block techniques have gained increased interest in treating postoperative pain. The erector spinae plane block (ESPB) is one of these techniques that proved effective in various surgical procedures, including breast surgery. It encompasses injecting the local anesthetic (LA) solution deep into the erector spinae muscle (ESM), which eventually spreads through the paravertebral space. Ultrasound-guided retrolaminar block (RLB) is another approach that was found to be effective for pain relief after thoracic surgery. In RLB, LA is injected into the space between the ESM and the lamina of the thoracic vertebra.
Both techniques are considered variants of paravertebral block; however, prospective studies comparing RLB and ESPB are limited. Therefore, this study was designed to compare the analgesic efficacy of ultrasound-guided retrolaminar block and erector spinae plane block in patients undergoing modified radical mastectomy.
Patients and Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
The patients will be randomly assigned into two equal comparable groups using computer- generated random numbers in opaque closed envelopes, each of which will include 30 patients. Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room.
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
- •Female patients
- •Type of surgery; Modified Radical Mastectomy (MRM)
- •Physical status ASA I, II, III.
- •Age ≥ 18 and ≤ 65 Years.
- •Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
排除标准
- •Age <18 years or >65 years
- •BMI <20 kg/m2 and >35 kg/m2
- •Known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
- •History of psychological disorders and/or chronic pain.
- •Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
- •Patient refusal.
- •Severe respiratory or cardiac disorders.
- •Advanced liver or kidney disease.
- •Pregnancy.
- •Physical status ASA IV and Male patients.
结局指标
主要结局
the total morphine consumed postoperatively for 24 hours
时间窗: 24 hours
the total morphine consumed postoperatively for 24 hours
次要结局
- postoperative nausea and vomiting PONV as side effect of morphine(at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively)
- duration of analgesia(at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively)
- the total intraoperative fentanyl consumption(intraoperative)
研究者
Ahmed Mohamed Soliman
lecturer of anesthesia
National Cancer Institute, Egypt