Effect of Adding Dexmedetomidine As Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Plane Block for Post Modified Radical Mastectomy Pain Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome will be the first time to request rescue analgesia.
研究概览
简要总结
The aim of the study is to assess the effect of adding dexmedetomidine to bupivacaine in US guided erector spinae plane block in modified radical mastectomy surgeries , Using visual analogue score and post-operative narcotics consumption.
Peripheral nerve blocks are effective adjuvant options for pain management in breast surgeries. The use of Erector spinae plane block (ESPB) has been proven to be very effective in controlling pain and minimizing narcotic consumption after modified radical mastectomy surgeries.
Many adjuvants to local anaesthetics were used to improve the duration and intensity of the peripheral nerve block.
详细描述
Breast cancer is one of the most important medical problems in the female gender, since among every eight women, one will suffer from breast cancer during her lifetime.
Acute post-operative pain is very common after breast surgeries which requires adequate pain management. Different peripheral nerve blocks such as paravertebral block had been used as an analgesic option for breast surgeries.
Erector spinae plane block is a newer interfascial plane block first described in 2016 who used it for treating thoracic neuropathic pain by injecting a local anesthetic deep into the erector spinae muscle at the level of T5. Moreover, ESPB is a reasonable option, with clearly identifiable sonographic landmarks and LA needle insertion and injection locations.
Later studies have shown that ESPB can provide effective analgesia in breast surgeries.
ESPB is achieved by injecting the local anesthetics locally deep to erector spinae muscle surface, as a part of multimodal analgesia. Given that erector spinae muscles anatomically situate along the thoracolumbar spine, ESPB promotes an extensive craniocaudal spread.
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, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age:30-65years.
- •Physical status: ASA I,II.
- •Localized breast cancer
排除标准
- •Age:<30 and >65 years.
- •Refusal of procedure or participation in the study by the patient.
- •Physical status: ASA III or above.
- •History of allergy to the study drug.
- •Bleeding disorders and coagulopathy.
- •Psychiatric illness that may interfere with the study.
- •Metastatic breast cancer.
研究组 & 干预措施
Patients receiving Block with Bupivacaine only
consists of patients receiving erector spinae plane block with Bupivacaine only
干预措施: Use Bupivacaine 0.25% Injectable Solution (Drug)
Patients receiving Block using Bupivacaine with Dexmedetomidine
consists of patients receiving erector spinae plane block using bupivacaine with Dexmedetomidine
干预措施: Bupivacaine 0.25% Injectable Solution plus Dexmedetomidine (Drug)
结局指标
主要结局
The primary outcome will be the first time to request rescue analgesia.
时间窗: From the end of the surgery till 24 hours
The investigators assess first time to request rescue analgesia according to A) pain score from 0 to 10 while 0 means no pain (best) and 10 means sever pain (worst).
The primary outcome will be the first time to request rescue analgesia
时间窗: From the end of the surgery till 24 hours
B) patient hemodynamics ex. Heart rate if patient is tachypneic (HR more than 100 beat/min) which is means that the patient is in pain.
次要结局
未报告次要终点