Comparison Between Analgesic Effect of Adding Dexamedatomidine or Dexamethasone to Bupvicaine in Rhomboidal Intercostal Plain Block and Subserratus Block in Breast Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Time of first request of analgesia.
研究概览
简要总结
The aim of this study is to evaluate the analgesic efficacy and safety of adding dexmedetomidine and dexamethasone to bupivacaine in rhomboidal intercostal and subserratus (RISS) block for patients undergoing modified radical mastectomy compared to bupivacaine only.
详细描述
Rhomboid intercostal block (RIB); a new interfascial plane block involves the triangle of auscultation that's bounded medially by inferior a part of the trapezius, inferiorly by the superior border of latissimus dorsi, and laterally by the medial border of the scapula. The local anaesthetic spreads between the rhomboid major and therefore the intercostal fascia at the extent of T6-T7 and provides analgesia of T3-T8 dermatomes.
Aiming to expand dermatomal coverage, a new modification of Rhomboid Intercostal and Sub-Serratus block (RISS) is performed by advancing the ultrasound probe caudally and laterally distal to the inferior angle of the scapula, the second injection apply between the serratus and intercostal muscle fascia. The RISS block is a novel ultrasound-guided block that has been shown to provide analgesia from T2-T11 dermatomes.
Dexmedetomidine is a potent selective α 2 adrenoceptor agonist that was reported in many previous studies as an adjunct to regional and general anesthesia, with significant prolongation of the duration of sensory block, motor block and analgesia, and accelerate the time to onset of sensory and motor block when added to a local anesthetic.
Dexamethasone is a potent long-acting steroid that has shown efficacy as an adjuvant to local anesthetics in various studies. It enhances peripheral nerve blocks when added to local anesthetics, providing better quality of anesthesia as well as postoperative analgesia. The mechanism by which dexamethasone prolong the duration of local anesthetics are not completely understood; however, some studies demonstrated that dexamethasone exerts its action through reducing the release of inflammatory mediators and by inhibiting discharge of C-fibers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult female patient
- •Type of surgery; Modified Radical Mastectomy (MRM).
- •Physical status ASA II, III.
- •Age ≥ 21 and ≤ 65 Years.
- •Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.
排除标准
- •Patient refusal.
- •Patients suffering from coagulation disorders.
- •Patients with histories of allergic reactions to local anesthetics or dexmedetomidine.
- •Patients suffering from neuropsychiatric disorders.
- •Pregnancy.
研究组 & 干预措施
dexamedatomidine
Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 1 Mcg/kg dexamedatomidine in 2 mL.
干预措施: Rhomboid Intercostal and Sub-Serratus block technique (RISS) (Procedure)
dexamedatomidine
Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 1 Mcg/kg dexamedatomidine in 2 mL.
干预措施: General Anaesthesia (Procedure)
dexamedatomidine
Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 1 Mcg/kg dexamedatomidine in 2 mL.
干预措施: dexamedatomidine (Drug)
dexamethasone
Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 8mg dexamethasone in 2 mL.
干预措施: Rhomboid Intercostal and Sub-Serratus block technique (RISS) (Procedure)
dexamethasone
Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 8mg dexamethasone in 2 mL.
干预措施: General Anaesthesia (Procedure)
dexamethasone
Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 8mg dexamethasone in 2 mL.
干预措施: dexamethasone (Drug)
saline
Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine+ 2 mL normal saline.
干预措施: Rhomboid Intercostal and Sub-Serratus block technique (RISS) (Procedure)
saline
Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine+ 2 mL normal saline.
干预措施: General Anaesthesia (Procedure)
saline
Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine+ 2 mL normal saline.
干预措施: saline (Drug)
结局指标
主要结局
Time of first request of analgesia.
时间窗: 24 hours
calculated from the time of complete injection of local anesthetics till the numerical rating scale (is more than or equals 3
次要结局
- heart rate(24 hours)
- Total amount of morphine consumption(24 hours)
- mean arterial blood pressure(24 hours)
- Numerical rating scale(24 hours)
研究者
bassant mohamed
Professor
Armed Forces College of Medicine, Cairo, Egypt
