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临床试验/CTRI/2025/05/087163
CTRI/2025/05/087163尚未招募不适用

A CROSS SECTIONAL COMPARATIVE STUDY TO EVALUATE THE EFFECT OF 0.125 PERCENT ROPIVACAINE WITH DEXMEDETOMIDINE 20 MCG AND 0.125 PERCENT BUPIVACAINE WITH DEXMEDETOMIDINE 20 MCG IN ULTRASOUND GUIDED SERRATUS ANTERIOR PLANE BLOCK IN BREAST SURGERIES

未提供1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
To compare the efficacy of ultrasound guided serratus anterior plane block for patients undergoing breast surgeries using Dexmedetomidine 20 mcg in Ropivacaine 0.125% or Bupivacaine 0.125% intraoperative based on hemodynamic changes and post operative analgesia requirement based on NRS score

研究概览

简要总结

60 ASA(American society of anesthesiogists) grade I ,II and III  patients planned for elective breast surgery,fulfilling the inclusion criteria will be included in the study.A day before surgery all patients with PAC (pre anaesthetic check-up) done will be reassessed and will be explained the anesthetic procedure.Patients will be explained about the procedure and due risks involved in their own local language and informed consent for the same will be taken.Local sensitivity testing will be done for patients to rule out hypersensitivity reactions to drugs used.Patient will be kept NBM (nil by mouth) for 6 hours before surgery.Patient will be premedicated with inj.Glycopyrollate 0.2 mg + inj.Midazolam 1mg. and preoxygenated with 100% Oxygen Patient will be induced with Inj. Fentanyl 2 mcg/kg + Inj. Propofol 2 mg/kg and patients airway will be secured with laryngeal mask airway (LMA) of appropriate size .For maintenance of anesthesia , inj.Propofol infusion 50-100 mcg/kg/min. + inhalational agent isoflurane will be  given.After securing airway, block will be given using either Ropivacaine 0.125 % with Dexmedetomidine 20 mcg and Bupivacaine 0.125% with Dexmedetomidine 20 mcg with 30 ml of drug volume in each group in accordance with grouping of cases.In SAP block —> needle is inserted in plane from medial to lateral direction in 4th rib in mid axillary line—> deposit Local anesthesia in plane between pectoralis major andserratus anterior muscle—> lateral cutaneous branches of intercostal nerves are blocked(5)In serratus anterior plane block , injection is given superficial between the latissimus dorsi and serratus anterior muscles at the level of the fifth rib on the midaxillary line which blocks the lateral cutaneous branch of the intercostal nerve and the long thoracic nerve .The block is performed with the help of a high frequency ( 6 to 13 MHz) linear transducer probe which will allow detailed visualization of superficial structures.If the effect of serratus anterior plane block is not appropriate during intraoperative time , which will be assessed by change in hemodynamic parameters with 20% increase from baseline being considered as significant , then additional analgesia (inj.Fentanyl 1-2 mcg/kg) will be given and such cases will be excluded from the study .Intraoperative monitoring will be done starting from incision time and then at appropriate incremental intervals till end of surgeryPostoperative hemodynamic changes will be noted at appropriate incremental intervals till first rescue analgesia is given.Rescue analgesia will be given with inj.Paracetamol 1 g IV stat when NRS score > 5 postoperatively.Postoperative adverse effects if any will be noted and managed accordingly.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Informed consent Age between 18-70 years .
  • American society of anesthesiology(ASA) physical status score of I, II and III Unilateral breast surgery.

排除标准

  • Patient with known allergy to drugs used in the study Bleeding diathesis Skin pathology at the injection site Patient with known psychiatric illness.

结局指标

主要结局

To compare the efficacy of ultrasound guided serratus anterior plane block for patients undergoing breast surgeries using Dexmedetomidine 20 mcg in Ropivacaine 0.125% or Bupivacaine 0.125% intraoperative based on hemodynamic changes and post operative analgesia requirement based on NRS score

时间窗: AFTER THE BLOCK,Intraoperative monitoring will begin at induction, followed by checks after LMA insertion, at incision, and then at 5, 10 minutes, and every 30 minutes until the end of surgery. Postoperative monitoring will include checks immediately after surgery, at 10 minutes, 1 hour, and then every 2 hours until the first rescue analgesia that is at NRS SCORE 5 is given.At this point assessment will end.

次要结局

  • To compare & evaluate time of first rescue analgesia on the basis of NRS score

研究者

发起方
未提供

研究点 (1)

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