Addition of Dexmedetomidine to Ropivacaine for Ultrasound Guided Erector Spinae Block: Evaluation of Effect on Postoperative Pain After Breast Surgery: A Double-Blinded, Prospective, Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Pain assessment in the first 24 hours post operatively: VAS score
研究概览
简要总结
Patients undergoing Partial or total mastectomy with axillary LN dissection will receive prior to induction of general anaesthesia ESP block at T4 level at the same side of the surgery. one group will receive ropivacaine 0.375% and the other will get ropivacaine 0.375% with dexmedetomidine 0.5mcg/kg as an adjuvant. time to first narcotic requirement will be documented and therefore an assessment of the duration of action of the block will be made
详细描述
Background and Objective: Whether partial or complete, mastectomy with axillary lymph node dissection is a painful surgery. Acute postoperative pain management is challenging and crucial due to high chances of it transforming into chronic pain. Erector spinae plane (ESP) block has been shown to be effective in managing post mastectomy pain.Dai et al showed the effectiveness of dexmedetomidine in prolonging the duration of sensory block, motor block and analgesia when dexmedetomidine as an adjunct is added to ropivacaine in brachial plexus block (1). The aim of our study is to show the effectiveness of dexmedetomidine in prolonging the analgesic effect of ropivacaine when added to it in ESP block compared to using ropivacaine alone in patients undergoing mastectomy with axillary lymph node dissection, and to study its impact on postoperative opioid consumption.
Methods: 44 American Society of Anesthesiologist (ASA) physical status classification class I, II and III will be randomly allocated to one of two groups, both receiving a single injection erector spinae plane block at T4 vertebral level using 20ml ropivacaine 0.375% 20 minutes before the induction of anesthesia. The first group will receive 0.5mcg/kg of dexmedetomdine added to the ropivacaine solution. The control group will receive no dexmedetomidine.
Postoperatively, patients in both groups will be receive acetaminophen 1g orally every 6 hours and oxycodone 5 mg orally as needed every 6 hours if VAS is more than 4. Postoperative pain will be measured using Verbal Analogue Scale (VAS) at 0, 1, 2, 4, 6, 12, 18, and 24 hours.
Conclusion: This study will be the first of its kind to investigate the impact of adding dexmedetomidine as an adjunct to ropivacaine in prolonging the ESP block duration in patients undergoing mastectomy 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
- Quadruple (Participant, Care Provider, Investigator, 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
- •ASA class I, II and III patients
- •Age range: 18-80 years old
- •Elective partial or unilateral radical mastectomy with sentinel lymph node dissection
排除标准
- •Pregnant woman
- •Bilateral mastectomy.
- •Skin infection at the site of needle puncture
- •Coagulopathy problems
- •Allergy or contraindication to any of the study drugs
- •Recent use of opioid drugs
研究组 & 干预措施
Precedex
participants will receive an ESP block with 20 ml Ropivacaine 0.375% in the induction room 20 minutes before their operation
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine
participants will receive an ESP block with 20 ml Ropivacaine 0.375% + 0.5mcg/kg dexmedetomidine in the induction room 20 minutes before their operation
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Pain assessment in the first 24 hours post operatively: VAS score
时间窗: 24 hours
Pain will be assessed using the VAS score ranging from 0, indicating no pain at all, to 10, indicating the worst pain the patient has ever felt
次要结局
未报告次要终点
研究者
Yara Al Jalbout
Clinical Instructor, Director Anaesthesiology Residency Program
Lebanese American University