跳至主要内容
临床试验/CTRI/2025/09/095254
CTRI/2025/09/095254尚未招募不适用

To evaluate a safety protocol to reduce Epidural Anaesthesia related complications in patients posted for knee replacement surgeries: A Randomized Trial

Adesh Institute Of Medical Sciences And Research Bathinda Punjab India1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年10月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
160
试验地点
1
主要终点
To evaluate a safety protocol of preloading of 10 ml /kg body weight of crystalloids, prophylactic use of intravenous glycopyrrolate and also pre- instillation of normal saline (5 ml) into the epidural space to prevent epidural placement related complications.

研究概览

简要总结

Epidural anaesthesia and analgesia has emerged as the gold standard regional anaesthetic technique for lower limb surgeries, particularly joint replacement procedures and major abdominal surgeries. With recent advances in anaesthetic practice, epidural anaesthesia has become a key modality for perioperative analgesia, offering superior pain control, reduced opioid requirements, enhanced patient tolerance, early mobilization, and cost-effectiveness compared to conventional approaches.

However, epidural catheter placement is not without complications. The most frequently encountered complications include hypotension, paresthesias, inadvertent vascular or subarachnoid cannulation, catheter insertion failure, post-dural puncture

headaches, non-uniform drug distribution, epidural hematomas, and vasovagal reactions. Among these, vasovagal attacks represent a particularly concerning complication that can manifest as sudden cardiovascular collapse with profound bradycardia and hypotension.

Vasovagal reactions during epidural procedures occur with an incidence ranging from 0-4% in general populations, with higher rates of 3.5% reported for epidural steroid injections specifically (Malave & Vrooman, 2022). These episodes can present with a

spectrum of symptoms including diaphoresis, nausea, vomiting, dizziness, palpitations, visual disturbances, and in severe cases, sudden cardiac arrest.

Three types of vasovagal responses have been described in the literature: a cardio inhibitory form (HR < 40 bpm), vasodepressor form (SBP < 80 mmHg or decrease by >30% without significant HR reduction), or mixed form (HR < 40 bpm and SBP < 80 mmHg or decrease by >30%) .

The literature shows that preloading of crystalloids prevents hypotension induced by spinal /epidural anesthesia,may help to prevent vasovagal reaction.

There are studies that tested that pre distending the epidural space with saline 5ml before epidural catheter  insertion can help to prevent intravascular placement by pushing blood vessels and other anatomical structures away from the catheter path, potentially ease in insertion of epidural catheter and reducing its intravascular placement.

The drug glycopyrrolate a quaternary ammonium compound, another antimuscarinic drug, has similar pharmacological effect like atropine but more prolonged action with minimal CNS side effects (as it does not crosses the Blood Brain Barrier).

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
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Age 18-65 years All genders ASA Grade I or II Body weight 50-90 kg Patients undergoing elective knee replacement surgeries.

排除标准

  • Spinal deformities or anatomical abnormalities Contraindications to spinal/epidural anaesthesia Abnormal hepatic, renal, or hematological parameters Patient refusal for regional anaesthesia Known allergy to study medications.

结局指标

主要结局

To evaluate a safety protocol of preloading of 10 ml /kg body weight of crystalloids, prophylactic use of intravenous glycopyrrolate and also pre- instillation of normal saline (5 ml) into the epidural space to prevent epidural placement related complications.

时间窗: According to Likerts Scale, easy catheter insertion is defined as if consultant who secures epidural catheter says that he/she agree (4) or strongly agree (5) that it is an easy and smooth insertion of epidural catheter. | Difficult insertion will be defined as if consultant who secures epidural catheter says that he/she strongly disagree (1) or disagree (2) or undecided (3) about easiness of insertion of epidural catheter.

次要结局

  • To find out the incidence of vasovagal attacks during epidural insertion.
  • To find out the associated complications related to epidural and the incidence of intravascular placement of epidural catheter.
  • To find out the uniformity of epidural drug spread/two segment regression & requirement of rescue analgesia.
  • To check the hemodynamic response.(T0- At the start of procedure)

研究者

发起方
Adesh Institute Of Medical Sciences And Research Bathinda Punjab India
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Yuvraj Walia

Adesh Institute Of Medical Sciences And Research, Bathinda(AIMSR), Punjab

研究点 (1)

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