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临床试验/CTRI/2019/12/022389
CTRI/2019/12/022389尚未招募不适用

“COMPARATIVE EFFICACY OF LEVOBUPIVACAINE AND ROPIVACAINE IN ULTRASOUND GUIDED SERRATUS ANTERIOR PLANE BLOCK FOR PATIENTS UNDERGOING UNILATERAL BREAST SURGERIES: A RANDOMIZED CONTROLLED TRIAL

Vijayanagar institute of medical sciences1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年12月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
44
试验地点
1
主要终点
To compare the duration of postoperative analgesia

研究概览

简要总结

Breast cancer is increasingly becoming the most common cancer among the females in India.  It accounts to around 25-32% of all female cancers in India as per National Cancer Registry1. Advances in Oncology has led to effective treatment in breast cancers.

 Breast cancers requires various surgical interventions like lumpectomy or mastectomy with axillary lymph node clearance. General anaesthesia is the conventional, most frequently used anaesthetic technique. Various regional anaesthetic techniques interventions have also been used for breast surgeries; these include local infiltration, thoracic epidural anaesthesia, thoracic  paravertebral blocks, thoracic spinal anaesthesia, and more recently, ultrasound guided interfascial plane blocks such as Pectoral nerves ( PECS ),  type 1 and  type 2, Serratus anterior plane block. Although the beneficial effect of regional anaesthesia is well known, data are emerging for other potentially beneficial effects of regional anaesthesia and analgesia on other perioperative outcomes. Those include decreased need of opioid analgesics for post-operative pain management, decreased post-operative nausea and vomiting (PONV).

 Serratus anterior plane block was described by Fajardo as a new ultrasound guided technique. Local anaesthetic is injected between serratus anterior and external intercoastal muscles in the mid-axillary line to block the lateral cutaneous branches of the intercoastal nerves mainly from T2-T9 before dividing into anterior and posterior branches. On injection of local anesthetic at this level also blocks the thoracic and thoracodorsal nerves.

 The long-acting local anaesthetics viz., Ropivacaine and Levobupivacaine have been developed after the evidence of bupivacaine-related severe toxicity. Both these agents are pure left-isomers and, based on their three-dimensional structure; they have less toxic potential both on the central nervous system and on the heart.  Although levobupivacaine is theoretically more potent than ropivacaine, clinical studies show conflicting results in terms of anesthetic and analgesic characteristics. Studies on various nerve blocks have shown that equipotent doses of ropivacaine and levobupivacaine have similar efficacy in peripheral nerve plexus blocks2. However, no study is available in the literature comparing the relative efficacy of these drugs in Serratus anterior plane block.

 This study is conducted to assess the comparative efficacy of Inj. Levobupivacaine and Inj. Ropivacaine in Serratus anterior plane block as a part of  multimodal analgesia inpatients undergoing unilateral breast surgeries under general anaesthesia.

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 65.00 Year(s)(—)
性别
Female

入选标准

  • ASA physical status I & II patients Female patients in the age group of 18 to 65 years.
  • Patients posted for elective unilateral breast surgeries with or without axillary clearance under general anaesthesia.

排除标准

  • Refusal by patients for the block.
  • Surgery duration more than 2 hours.
  • History of significant systemic disorders (cardiovascular, respiratory, central nervous system or renal system).
  • Infection at block site of block.
  • Thoracic wall and chest wall deformities.
  • Allergy to the study drugs.

结局指标

主要结局

To compare the duration of postoperative analgesia

时间窗: Study parameters are observed and recorded just before the administration of block, 5 minutes after administration, at the time of skin incision and every 10 minutes intra-operatively following the block till extubation and post-operatively at 5 min, 15min, 30min, then hourly for first 2 hours and at 4,6,12,24hrs after extubation. Post-operative pain will be assessed using visual analog scale (VAS) at rest and at coughing. Inj.tramadol 50 mg IV is used as rescue analgesic when VAS score is 4.

次要结局

  • the need for rescue analgesic,(total dose of rescue analgesic required,)

研究者

申办方类型
Government medical college

研究点 (1)

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