Comparison of mid-point transverse process to pleura (MTP) block and Erector spinae plane block for post-operative pain in modified radical mastectomy patients: A double blinded randomized trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The primary outcome of our study will be to assess visual analogue scale in post operative period for 24 hours.
研究概览
简要总结
Modified radical mastectomy (MRM) is associated with significant post operative pain and regional anaesthetic techniques are of potential benefit. Erector spinae plane block is a recently described technique for various surgeries at different thoracic levels. A double blinded randomized controlled trial is planned to compare the efficacy of ultrasound guided erector spinae plane block (ESP) with a newer approach to paravertebral block, mid-point transverse process to pleura (MTP) block Patients belonging to American Society of Anesthesiologists (ASA) physical status grade I,II and III aged between 18 to 75 years and undergoing MRM will be enrolled after informed consent. Two groups will be formed, one for each block. Unilateral block will be given preoperatively at T3 or T4 with 20 ml of 0.5% ropivacaine, catheter will be left in situ and analgesic effect will be assessed post operatively. With routine monitoring patient will be operated under general anaesthesia. Intraoperatively an infusion of 0.5% ropivacaine and post operatively an infusion of 0.2% ropivacaine will be infused at a rate of 5ml/hr. Pain will be assessed based on Visual analogue scale at fixed time intervals and the time of first rescue analgesia will be recorded. It will be a double blinded randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA grade 1, 2 and 3 Scheduled to undergo MRM.
排除标准
- •1.Patient refusal 2.Preexisting infection at block site 3.Coagulation Disorder 4.Preoperative hypotension (Mean arterial blood pressure < 50 mmHg), preoperative bradycardia (Heart rate < 45 beats/min) and preoperative dysrhythmia.
- •5.History of psychiatric illness and preexisting neurological deficits 6.Patient with morbid obesity BMI >40 kg m2 7.Pregnant patients 8.Decreased pulmonary reserve, cardiac disorders and renal dysfunctions 9.Known allergy to study drugs 10.Patient with fungating growth or growth with infection at site of block 11.Patient posted for repeat surgery.
- •12.Presence of any preoperative pain or history of chronic pain 13.History of regular analgesic use 14.History of pre operative radiotherapy and chemotherapy.
结局指标
主要结局
The primary outcome of our study will be to assess visual analogue scale in post operative period for 24 hours.
时间窗: The primary outcome of our study will be to assess visual analogue scale in post operative period for 24 hours.
次要结局
- The secondary outcome will be to assess and compare duration of analgesia (time to use first rescue analgesic), total amount of rescue analgesic used during 24 hours, duration to perform block, incidence of procedure related complications and postoperative complications, failure rate and patient satisfaction.(analgesia for next 24 hours at 1hr, 2hr,3 hr,4hr,8hr,12hr,16hr,20 hr and 24 hr post operatively.)