Comparison of the analgesic efficacy two approaches to the ultra-sound guided erector spinae plane block in patients undergoing modified radical mastectomy: A randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Efficacy of analgesic technique determined by 11-point numeric rating scale (NRS) at rest & on abduction of ipsilateral arm above the head.
研究概览
简要总结
Breast Surgery is associated with significant peri-operative pain and chronic pain. Various pain management modalities have been tried to alleviate the pain, erector spinae plane block is one of them. Recently a cadaveric study has shown two new approaches of erector spinae plane block namely "Erector Spinae Plane Block between Transverseprocesses (BTWN)" and "Erector Spinae Plane Block at medial transverse process(MED)". We wish to compare the efficacy of these two approaches of erector spinae plane block, its analgesic efficacy, its effect on perioperative opioid consumption, patient satisfaction and side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •a) ASA I- II b) Scheduled to undergo elective modified radical mastectomy.
排除标准
- •a) Patient refusal for regional techniques b) All contra-indications to regional techniques: Local or systemic infection Known allergy to the study drugs Bleeding disorders Platelet count <80,000/μL of blood c) BMI > 35 d) Inability to use PCA device post operatively.
结局指标
主要结局
Efficacy of analgesic technique determined by 11-point numeric rating scale (NRS) at rest & on abduction of ipsilateral arm above the head.
时间窗: Post-operative period at 0, 0.5, 1, 2, 4, 6, 12 & 24 hours
次要结局
- Intraoperative opioid consumption.(Intraoperative period)
- 24-hour fentanyl consumption(1st 24 hours of post-operative period)
- Time to first analgesic requirement in post-operative period.(1st 24 hours of Post operative period)
- Patient satisfaction score(Post-operative period at 0, 0.5, 1, 2, 4, 6, 12 & 24 hours)
- ï¬Incidence of adverse events (postoperative nausea/ vomiting, respiratory depression, pruritus, urinary retention) retention)(1st 24 hours of post-operative period.)