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临床试验/CTRI/2026/01/102053
CTRI/2026/01/102053尚未招募2 期

A randomized comparative study to evaluate the efficacy of ultrasound guided pericapsular nerve group block versus ultrasound guided suprainguinal fascia Iliaca block for ease of positioning during spinal anaesthesia in cases of acetabular fractures posted for open reduction and internal fixation SMS Medical College Jaipur

Sawai Man Singh Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年2月4日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
1. To assess and compare NRS score at rest and on passive 15-degree limb elevation every 5min after the block till NRS less then 2 is achieved.

研究概览

简要总结

Acetabular fractures although constitute only 1.5 -3% of geriatric orthopaedic trauma but are on the rise. A large proportion of them are elderly with multiple comorbidities and their associated challenges. It is a painful condition both at rest and on slight movement, good  perioperative analgesia is mandatory for these patients, like in any other orthopaedic trauma.  Many recipes have been tried for perioperative pain relief ranging from systemic analgesia with or without opioids to multimodal analgesia.  Many regional blocks like femoral nerve block, fascia iliaca, supra inguinal fascia iliaca and peri capsular nerve group  block have been tried as part of multimodal analgesia.These days acetabular fractures are fixed surgically, anaesthesia of choice for these patients is central neuraxial block and many times combined spinal epidural for both long duration surgeries and postoperative analgesia. For these blocks sitting position is preferable as patients find it difficult to lie on the side. To perform these blocks successfully in one go the patient has to be pain free and comfortable. Systemic analgesia is a choice, but at times it does not offer adequate analgesia and patient sometimes feel a little dizzy if they are given opioids. So we all look forward to good regional blocks for effective analgesia during positioning these patients for central neuraxial blocks. Literature suggests both supra-inguinal fascia iliaca block and pericapsular nerve group block offer pain relief in acetabular fractures. We undertake this study  to find out which is superior. It is very important that patients are comfortable and are able to sit properly to give a good position making things comfortable both for patients and anaesthesiologists. Also, the central neuraxial block can be done atraumatically, very basic requirement in central neuraxial blocks.In this study we aim to evaluate the efficacy of Supra-inguinal fascia iliaca block versus Pericapsular nerve group block for ease of positioning during spinal anaesthesia in acetabular fractures posted for open reduction and internal fixation using 20ml of o.25% Bupivacaine and 2mg Dexamethasone.

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

  • 1.Patients undergoing open reduction and internal fixation for acetabular fracture under spinal anaesthesia 2.Patients consenting to participate.
  • 3.Adult patients aged 18-65 Years.
  • 4.Patients belonging to American Society of Anesthesiologists(ASA) grade I, II and III.

排除标准

  • 1.Patients who will not be able to assist in block assessment.
  • 2.Those with preexisting neuropathy.
  • 3.Having coagulopathy .
  • 4.Allergic to local anesthetics.
  • 5.Infection at the local site of administration of block 6.Patient should not be part of any other study.

结局指标

主要结局

1. To assess and compare NRS score at rest and on passive 15-degree limb elevation every 5min after the block till NRS less then 2 is achieved.

时间窗: 1. At baseline, 5 min, 10 min,15 min till NRS less then 2 | 2. At baseline, 5 min, 10 min, 15 min till NRS less then 2 | 3. At baseline, 15 min during positioning

2. To assess and compare time taken to achieve NRS less then 2 in both the groups.

时间窗: 1. At baseline, 5 min, 10 min,15 min till NRS less then 2 | 2. At baseline, 5 min, 10 min, 15 min till NRS less then 2 | 3. At baseline, 15 min during positioning

3. To assess and compare the difference in sitting angle before the block and at positioning for spinal anaesthesia between the two groups.

时间窗: 1. At baseline, 5 min, 10 min,15 min till NRS less then 2 | 2. At baseline, 5 min, 10 min, 15 min till NRS less then 2 | 3. At baseline, 15 min during positioning

次要结局

  • 1. To assess & compare NRS postoperatively every 6 hrly for 24hr between the groups(2. To determine & compare amount of Tramadol iv (mg) used in first 24 hr postoperatively in both the groups.)

研究者

发起方
Sawai Man Singh Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Vandana Mangal

Sawai Man Singh Medical College, Jaipur

研究点 (1)

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