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临床试验/CTRI/2024/02/062220
CTRI/2024/02/062220尚未招募4 期

A randomized comparative study to assess the effect of intrathecal magnesium sulphate as an adjuvant to hyperbaric bupivacaine versus isobaric levobupivacaine on post operative analgesia in parturients undergoing elective caesarean section at SMS Medical college Jaipur

Department of anaesthesia sawai man singh medical college and attached hospital jaipur1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2024年2月5日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
74
试验地点
1
主要终点
1. Mean duration of Post op analgesia.

研究概览

简要总结

Spinal Anaesthesia with hyperbaric bupivacaine and isobaric levobupivacaine is the most preferred technique of Anaesthesia in parturient undergoing lower segment caesarean sections (LSCS) which provides effective pain relief during intra operative and early postoperative period along with avoiding the risks of general Anaesthesia. However, recent studies show us that about 50%–70% of patients complain of moderate to severe pain after LSCS indicating that postoperative pain remains poorly managed.

For this a total of 74 patients (n=74) undergoing elective caesarean section who satisfy the inclusion criteria will be randomly divided into two groups of 37 each (A and B). Group A patients will be receiving hyperbaric bupivacaine 0.5% plus magnesium sulphate (75 mg) and group B will be receiving isobaric levobupivacaine 0.5% plus magnesium sulphate (75 mg).

When patients arrive in the operating room (OR), intravenous cannula (IV cannula) will be secured and hemodynamic variables will be measured. After this, spinal Anaesthesia will be administered using hyperbaric bupivacaine 0.5% plus magnesium sulphate (75 mg) in group A and isobaric levobupivacaine 0.5% plus magnesium sulphate (75 mg) in group B. Surgery will start after the block reaches T6 sensory level (complete sensory block). Quantitative values of time of onset of sensory loss, time of onset of complete motor block, time taken for sensory regression and post operative analgesia will be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Written Informed consent for this study
  • Adult age group
  • Patients undergoing elective caesarean section
  • Gestational age 37-42 weeks
  • ASA Grade-â…¡.

排除标准

  • High risk pregnancy like intrauterine growth restriction, eclampsia, preeclampsia, short stature, twin Gestation, maternal cardiovascular disorders, Endocrine disorders, pulmonary disorders, Chronic kidney and liver disorders
  • Parturient with contraindications for neuraxial block like lack of consent, elevated ICP, preexisting neurological disease, severe dehydration, hypovolemia, thrombocytopenia, coagulopathy, history of allergy to study drug
  • Patient should not be a part of other study
  • Non co-operative patient.

结局指标

主要结局

1. Mean duration of Post op analgesia.

时间窗: 1. 0 hrs | 2. 1 hrs | 3. 3 hrs | 4. 6 hrs | 5. 12 hrs | 6. 24 hrs

次要结局

  • 1. Mean time of onset of sensory block (minutes).(2. Mean time of onset of motor block (minutes).)

研究者

发起方
Department of anaesthesia sawai man singh medical college and attached hospital jaipur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Savita Meena

Department of anaesthesia sawai man singh medical college and attached hospital

研究点 (1)

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