U/S Guided SAB VS U/S Guided SAB With Modified Pectoral Nerve Block in Modified Radical Mastectomy,Randomized Double Blinded Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The total amount of morphine consumption in the first 24 hours postoperatively
研究概览
简要总结
We hypothesize that ultrasound guided serratus anterior plane block Combined With Modified Pectoral Nerve Block is going to be more effective than Ultrasound guided Serratus anterior plane block alone in patients undergoing MRM as modified Pecs block involves the block of medial and lateral pectoral nerves which are spared in case of serratus block alone, resulting in reducing myofascial pain and opioid consumption.
详细描述
Ultrasound guided Serratus anterior plane block was introduced in 2013 for analgesia of breast and lateral thoracic wall surgery. At the axillary fossa, the intercostobrachialis nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve, and thoracodorsal nerve are located in a compartment between the serratus anterior and the latissimus dorsi muscles, between the posterior and midaxillary lines at this plane local anesthetic will be injected . Complications of serratus anterior plane block include local anesthetic toxicity and pneumothorax , unfortunately medial and lateral pectoral nerves are preserved which are responsible for the myofacial pain .
The pectoral nerves (Pecs) block types I and II (Modified Pectoral block) , is less invasive technique described by Blanco et al where local anesthetic is deposited into the plane between the pectoralis major muscle(PMm) and the pectoralis minor muscle (Pmm) (Pecs I block)and above the serratus anterior muscle at the third rib (Pecs IIblock).,Blocking intercostobrachial, third to sixth intercostals the long thoracic nerves in addition to medial and lateral pectoral nerves.
Addition of Modified Pecs block to Serratus anterior plane block will enhance the control of pain as it block the medial and lateral pectoral nerves which are responsible for the myofacial pain and which are spared in case of Serratus block alone .
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
- 是
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 anaesthetics, opioids).
- •History of psychological disorders and/or chronic pain.
- •Contraindication to regional anaesthesia 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 amount of morphine consumption in the first 24 hours postoperatively
时间窗: Through Study Completion
The total amount of morphine consumption in the first 24 hours postoperatively
次要结局
- Postoperative nausea and vomiting (PONV) as side effects of morphine.(Through Study Completion over the first 24 hrs postoperative)
- Heart rate, mean arterial blood pressure and VAS (at rest and during movement) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.(Through Study Completion over the first 24 hrs postoperative)
- Patient satisfaction the patient will be classified in this group to satisfied or not.(Through Study Completion over the first 24 hrs postoperative)
- Complications related to blocks such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture (US check postoperative).(Through Study Completion over the first 24 hrs postoperative)
- Total amount of intraoperative fentanyl will be recorded.(Through Study Completion over the first 24 hrs postoperative)
- Time of first rescue analgesia(Through Study Completion over the first 24 hrs postoperative)
- Change in heart rate and mean arterial blood pressure intraoperatively at 30 minutes interval in comparison to baseline reading.(Through Study Completion over the first 24 hrs postoperative)
- The degree of postoperative sedation according to Ramsay scores(Through Study Completion over the first 24 hrs postoperative .)
- Morphine related complications such as respiratory depression, urine retention or pruritis(Through Study Completion over the first 24 hrs postoperative)
研究者
Ahmed Abdalla
Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University
Cairo University