跳至主要内容
临床试验/CTRI/2024/08/073009
CTRI/2024/08/073009尚未招募2/3 期

Comparative analysis of duration of post-operative analgesia between inj ropivacaine 0.375% with inj. Nalbuphine 1.5mg versus inj. Ropivacaine 0.375 % with 1g mgso4 using usg guided tap block in patients undergoing lscs a prospective randomised study.

Dr Prem Kumar R1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月10日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1.Duration of Postop analgesia

研究概览

简要总结

Post‐operative analgesia is important after surgery to avoid various complications such as venous thromboembolism, respiratory complications and prolonged hospital stay.The transverses abdominis plane (TAP) block blocks T6–L1 nerve branches and is increasingly playing a role in postoperative analgesia for lower abdominal surgeries. It decreases opioid consumption with the benefits of reducing opioid side effects specially nausea and vomiting. Also earlier ambulation and less hospital admission. Various trials have demonstrated the efficacy of transversus abdominis plane (TAP) block as a component of multimodal postoperative analgesia after cesarean section and lower abdominal surgeries.

 The block, first described by Rafi in 2001,is a simple and safe technique for analgesia after cesarean section, whether guided by anatomic landmarks or by ultrasound. TAP block in cesarean section is carried out by local anesthetics such as bupivacaine or ropivacaine with a limited duration of action1.

 Ropivacine: It is a long acting anaesthetic drug belonging to amide group of local anaesthtic. Ropivacine have a greater degree of motor sensory differentiation which could be usefull when motor blockade is undersirable. The reduced lipophilicity is also associated with decreased potential for central nervous toxicity and cardiotoxcity. It is metabolized extensively in the liver and excreted in urine(2)

 In our study an effort has been made to compare duration post operative analgesia between Ropivacaine with Nalbuphine versus Ropivacaine with Magnesium Sulphate  in patients undergoing lower segmental cesarean section.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
19.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • ASA I to II Female patients.
  • Aged between 19 to 40 years.
  • Normal liver and renal function test, Coagulation profile.
  • Undergoing lower segment cesarean section surgery.

排除标准

  • Patients having allergy to LOCAL ANAESTHETICS AND MAGNESIUM SULPHATE.
  • Patient with history of mental disorder.
  • Patient refusal.
  • Infection at the site of procedure.
  • Morbid Obesity.

结局指标

主要结局

1.Duration of Postop analgesia

时间窗: 0,1,2,4,6,8,10,12,24 hours

2.Rescue analgesia

时间窗: 0,1,2,4,6,8,10,12,24 hours

次要结局

  • Hemodynamic parameter like NIBP,HR and SPO2 for 24 hours post operatively(time for first resuce analgesia)

研究者

发起方
Dr Prem Kumar R
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Prem kumar R

rajarejeswari medical college

研究点 (1)

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