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临床试验/CTRI/2025/04/084622
CTRI/2025/04/084622尚未招募3 期

Comparing the effect of Magnesium sulphate with Bupivacaine versus Dexmedetomidine with Bupivacaine versus plain Bupivacaine in Transversus Abdominis Plain block for post operative analgesia in patient undergoing Elective Lower Segment Caesarean section

Bhaarath medical college1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年4月21日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
To compare the duration of analgesic effect

研究概览

简要总结

The objective of the study is to compare the effect of magnesium sulphate with bupivacaine versus dexmeditomidine with bupivacaine versus dexmeditomidine with bupivacaine versus plain bupivacaine in transversus abdominis plane block in patients undergoing elective LSCS .

Every patient will undergo pre anaesthetic assessment and a informed written consent will be obtained after explaining about the block. Patients will be kept NPO for 6 hours prior to surgery. On arrival in the operating room patient will be connected to the monitors such as electrocardiogram, pulse oximeter, and non-invasive blood pressure monitor. A 18 gauze peripheral venous cannula was inserted and intravenous fluid will be administered.

Patients will be monitored for hemodynamic parameters such as heart rate, systolic blood pressure and diastolic blood pressure and saturation in the above mentioned intervals.

They will be randomly divided into three groups.

Group B     -   30 patients will receive only 20 ml of  inj bupivacaine 0.25 %  on each side and 2 ml of normal saline.

Group BM  -   30 patients will receive 20 ml of  inj bupivacaine 0.25 %  on each side and 0.5 ml of normal saline and 1.5 ml

of   Magnesium sulphate ( 150 mg )

GROUP BD  -  30 patients will receive 20 ml of  inj bupivacaine 0.25 %  on each side and 2ml of dexmeditomidine

(1       mcg/kg )

Under aseptic precautions at the level of L 3 – L 4 or L4 – L5 spinal anaesthesia will be given. Inj bupivacaine 0.5 % heavy 2 ml with fentanyl as adjuvant will be used for spinal anaesthesia. Post-surgery patients will receive bilateral TAP block under USG guidance .Lateral approach for TAP block will be done.

Post procedure duration of pain free period, intensity of pain using VAS score will be monitored at intervals of 4hours, 8 hours, 12 hours, 16hours and 24 hours. Need for rescue analgesia will be monitored in the above mentioned intervals. If the need of rescue analgesia is only inj.paracetamol 1g within 24 hrs post-surgery it will be scored as 1, if it is 2g within 24 hours it will be scored as 2, and if more than 3g within 24 hours it will be scored as 3. If patient is not responding to inj paracetamol1g and the time period has not crossed more than 8hours patient will receive inj.diclofenac 75mg IV as a pain relief medication and it will scored as 4. Patient requiring more than the mentioned analgesic dose for pain relief will be excluded from the study.

Patients will be monitored for hemodynamic parameters such as heart rate, systolic blood pressure and diastolic blood pressure and saturation in the above mentioned intervals.

研究设计

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

入排标准

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

入选标准

  • All patients undergoing Elective LSCS.

排除标准

  • Patients Already On Magnesium Sulphate therapy Patients With Coagulation Abnormality Patients with infection at Injection site.

结局指标

主要结局

To compare the duration of analgesic effect

时间窗: at 4 hours, 8 hours, 12 hours, 16th hour , 20 and 24

to compare the VAS score

时间窗: at 4 hours, 8 hours, 12 hours, 16th hour , 20 and 24

次要结局

  • Requirement of rescue analgesia for 24 hours post blockade(at 4 hours, 8 hours, 12 hours, 16th hour , 20 and 24)

研究者

发起方
Bhaarath medical college
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Keerthiga M

Bhaarath medical college

研究点 (1)

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