Comparison of efficacy of Ultrasound guided Paravertebral Block versus Erector Spinae Plane block for Postoperative Analgesia in Modified Radical Mastectomy : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AIIMS
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To measure the duration of post-operative analgesia (that is, time to first analgesic request from the time of giving block ).
研究概览
简要总结
Acute postoperative pain due to insufficient pain control is a major risk factor for development of chronic pain after breast surgery. Regional anaesthesia is considered protective for cancer recurrence by its direct and indirect anti proliferative effects. Use of these techniques is associated with better pain control , decreased opioid consumption and their side effects. Paravertebral block is a established regional anaesthesia and analgesia technique for breast cancer surgeries.However erector spinae plane block is a novel interfacial block technique which can be a viable alternative to paravertebral block due to its fast , easy and safe execution . There are numerous studies on paravertebral block but there is a very limited literature on erector spinae plane block in breast surgeries and there is no study comparing paravertebral block with erector spinae plane block in breast surgeries.Thus we are performing this randomized controlled trial to compare the efficacy of paravertebral block with erector spinae plane block in breast surgeries in total 80 patients ( 40 in each group). In Group P , ultrasound guided paravertebral block will be given at T4 level with 20 ml of 0.5 % Ropivacaine and in Group E , ultrasound guided erector spinae plane block will be given at T5 level with 20 ml of 0.5 % Ropivacaine. After giving the block , GA will be given.Any block related complications will be noted. In postoperative period the efficacy of both the blocks will be compared in terms of duration of postoperative analgesia (time to first rescue analgesic ) , total number of rescue analgesics required and patient satisfaction .
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.ASA I and II 2.Patients posted for MRM 3.Patients giving written informed consent to participate in the study.
排除标准
- •1.Patient refusal 2.Age <18 or > 70 years 3.Patients with BMI > 35kg/m2 4.Patient with infection at the site of injection 5.Coagulopathy 6.Spine deformity 7.Drug addicts or history of opioid dependence 8.Patients with history of allergy to opioids or local anaesthetics.
结局指标
主要结局
To measure the duration of post-operative analgesia (that is, time to first analgesic request from the time of giving block ).
时间窗: Pain assessment would be done in immediate post (0 min), 30 min, 1 hr , 2hr , 6hr, 12 and 24 hr.
次要结局
- 1) Total rescue analgesic requirement in postoperative period.(2) To evaluate patient satisfaction in postoperative period.)