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临床试验/CTRI/2023/11/059419
CTRI/2023/11/059419尚未招募1 期

The effect of two different doses of dexamethasone on blood sugar levels when added as an additive to local anaesthetic in transversalis fascia plane block in caesarean section surgeries - an observational study

Narayana Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年9月11日最近更新:

试验速览

阶段
1 期
状态
尚未招募
入组人数
100
试验地点
1
主要终点
To assess the effect of 4mg dexamethasone and 8mg dexamethasone added to levobupivacaine on postoperative blood sugars

研究概览

简要总结

Adequate post-operative analgesia after caesarean section (CS) is vital as it impacts the recovery of the parturient. Ultrasound guided fascia plane blocks are being given post surgery to alleviate pain and decrease the consumption of opioids. One such novel technique is the transversalis fascia plane block. The transversalis fascia plane (TFP) block is an ultrasound-guided regional anesthetic technique that targets the T12 and L1 spinal nerves by injecting local anesthesia between the posterior aponeurotic extension of the transversus abdominis muscle and the deep investing transversalis fascia which provides postoperative analgesia for parturients undergoing Caesarean section.  Dexamethasone is often added as an additive to prolong the duration of action of local anaesthetic but steroids are known to increase blood glucose levels above the physiological levels. In this study we are going to monitor the effect of addition of 2 different concentrations of dexamethasone on post operative blood sugars, surgical site infection and postoperative analgesia.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • Weight 40-70 kg, BMI<35kg/m
  • Patient aged between 20- 40years.
  • ASA II listed for elective Caesarean section.

排除标准

  • Patients without valid informed and written risk consent 2) ASA III and IV 3) Patients with BMI>35kg/m
  • Use of oral anticoagulants 5) Allergy to study drugs •Local infection •Severe psychiatric disorders.

结局指标

主要结局

To assess the effect of 4mg dexamethasone and 8mg dexamethasone added to levobupivacaine on postoperative blood sugars

时间窗: 2hours postoperatively and fasting blood sugars on postoperative day 1,2 and 3

次要结局

  • To assess VAS Scores in both the groups(immediately,6hr,12hr,24 hrs)
  • To assess the occurrence of surgical site infection in both the groups(30 days)

研究者

申办方类型
Private medical college

研究点 (1)

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