Comparison between costotransvere block and erector spinae plane block for perioperative analgesia in patients undergoing modified radical mastectomy -A prospective randomised double blinded trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- to compare the analgesic efficacy for post operative pain management with respect to 24hr morphine consumptiom
研究概览
简要总结
INTRODUCTION
There is an increasing incidence of cancer and breast cancer is the most common cancer in women accounting to 25.8 per 100,000 women, in India1. Surgery remains the prime modality of treatment for these patients. About 10-20% of surgical patients experience acute post-operative pain, which may progress to post mastectomy pain syndrome in 25-60% patients if adequate pain relief is not provided2.
Regional anesthesia techniques provide excellent perioperative analgesia 3and also reduce post-operative nausea, vomiting. Several regional anaesthesia techniques have been described for perioperative analgesia, however no single technique is proven better than the other. Erector spinae plane block and costo-transverse plane block are recent additions under US guided posterior thoracic blocks. Seelam et al used US guided ESPB for female patients undergoing modified radical mastectomy and evaluated its analgesic efficacy in reducing perioperative pain4. Nielsen et al in his cadaveric study, described US guided costo- transverse block as relatively new peri-paravertebral block. They checked for spread of injected dye in this block and erector spinae plane block5. The spread of local anaesthetic in costotransverse block involved better spread to ventral ramus than erector spinae plane block which possibly will give better analgesia.
Methodology :After obtaining written informed consent computer generated randomization will be done. Patients will be randomized to receive either a singleâ€shot USâ€guided ESPB (ESP group) or single-shot US- guided costo transverse block After confirming nil by mouth status , patients will be wheeled in operation room and ASA standard monitors will be connected. General anaesthesia using iv Xylocard 1.5 mg/kg ,iv Fentanyl 2mcg/kg (ideal body weight ), iv Propofol 1.5 -2mg/kg.and neuromuscular block will be achieved with atracurium 0.5mg/kg. Airway will be secured with an appropriately sized Supraglottic airway/ ETT General anesthesia will be maintained with oxygen- medical air and Sevoflurane using volume controlled ventilation and dial concentration adjusted to target end tidal concentration of isoflurane of 1.2 .Dexamethasone 0.1mg/kg, iv Magnesium 40mgs/kg, iv Paracetamol 20mg/kg (maximum 1 gm) will be given after induction.as a part of multimodal analgesia. Post induction patients will be placed in lateral decubitus position and as per group allocated either US guided ESPB or US guided costo transverse block will be performed . Fentanyl 0.5 mcg/kg (maximum 50 mcg) will be administered to all the patients who have a sympathetic response to pain on incision i.e. if the heart rate and blood pressure is raised by at least 20% of baseline. Post extubation patient will be shifted to a highâ€dependency unit. The Numerical rating scale will be used to assess pain postoperatively. Intravenous paracetamol 1 g every 8 h will be continued in the postoperative period. Intravenous morphine will be used as rescue analgesic in both groups, if the NRS score was more than 4, 3mg iv morphine will be administered, and patient will be reassessed after 15 mins. If NRS is more than 4 a repeat dose of 3mg of morphine will be given.
USâ€guided ESPB technique :A linear array highâ€frequency US probe (GE VENUE GO TM) will be used for performing the block, which will be placed in craniocaudal orientation in the midline. The probe will then be moved laterally to identify T4 transverse process (TP), which is usually at 2.5–3 cm from spinous process laterally~~.~~ ESM, rhomboidus major, and trapezius muscle will be identified. Under aseptic precautions 10 cm block needle (Stimuplexï£¨ï€ Ultra 360ï£¨ï€ 22 G, Bâ€Braun) will be introduced inâ€plane craniocaudally under vision and navigated till the TP is encountered. Hydro dissection with 2 ml normal saline will be done to confirm separation of ESM from TP. Under US guidance, 25ml 0.5% bupivacaine will be injected and drug spread will be seen in the ESP plane craniocaudally in real time.
USG guided CTB block :A high frequency linear USG transducer will be placed 2-2.5cm lateral to the spinous process of the 4th thoracic vertebra. CTB block will be performed unilaterally on the ipsilateral side of surgery. The skin and subcutaneous layers, trapezius and erector spinae muscles, third and fourth transverse processes, intertransverse and superior costotransverse ligaments (SCTL) as well as the pleura will be placed in the field of view. A needle will be advanced parallel to the SCTL, will be stopped immediately before reaching the cranial part of the fourth rib. In-plane technique will be used and the needle will be advanced cephalo-caudally. Here, 25ml 0.5% bupivacaine will be injected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- Female
入选标准
- •ASA 1 2 3 BMI LESS THAN 35 SURGERY MRM.
排除标准
- •PATIENT REFUSAL AGE LESS THAN 25YEARS AND MORE THAN 65 YERAS ASA 4 BMI MORE THAN 35 LOCAL ANESTHETIC ALLERY INFECTION AT THE INFECTION SITE COAGULOPATHY RENAL DYSFUNCTION HEPATIC DYSFUNCTION.
结局指标
主要结局
to compare the analgesic efficacy for post operative pain management with respect to 24hr morphine consumptiom
时间窗: 0,30,60,90,120 mins | 4,6,8,12,16,20,24 hrs
次要结局
- 1.to assess and compare time required to perform the block(2.to assess and compare intraoperative hemodynamics - before ansd after skin incision)
研究者
Dr Aanchal Bharuka
Basavatarakam Indo-American Cancer Hospital and Research Institute,Hyderabad
