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临床试验/CTRI/2024/05/067143
CTRI/2024/05/067143已完成不适用

Comparison between costotransvere block and erector spinae plane block for perioperative analgesia in patients undergoing modified radical mastectomy -A prospective randomised double blinded trial

Dr Aanchal Bharuka1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月20日最近更新:

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 single‐shot US‐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 high‐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.

US‐guided ESPB technique :A linear array high‐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 (StimuplexUltra 36022 G, B‐Braun) will be introduced in‐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

发起方
Dr Aanchal Bharuka
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Aanchal Bharuka

Basavatarakam Indo-American Cancer Hospital and Research Institute,Hyderabad

研究点 (1)

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