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临床试验/CTRI/2023/07/054945
CTRI/2023/07/054945尚未招募Phase 3 4

Comparison of Ultrasound Guided Pericapsular Nerve Group Block with Suprainguinal Fascia Iliaca Block for Reducing Pain in Patients with Hip Fracture before Positioning for Subarachnoid Block.

Prachi Ranjan1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年7月20日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Compare Analgesia provided by ultrasound guided pericapsular nerve group block with that of suprainguinal fascia Iliaca block measured by numerical rating scale score on passive limb elevation of 15 degrees at 30 minutes post block in patients with hip fracture before positioning for subarachnoid block.

研究概览

简要总结

This study is a Prospective randomized interventional comparative study with an aim to to compare analgesiaprovided by ultrasound guided pericapsular nerve group block with that of suprainguinalfascia iliaca block  in patients withhip fracture before positioning for subarachnoid block.This study will be done in single centre in india. In this study-1.Pre Procedural pain will beassessed during rest as well as movement of 15° passive elevation of affectedlimb and recorded on numeric pain rating scale (NRS) 0=no pain,10=worstimaginable pain.

  1. At 30mins after administeringthe block, pain will be measured by NRS at rest and on passive limb elevation of15°. (Primary objective)

If the patient reports a NRSscore ≥4 during 15° passive elevation of affected limb, intravenousfentanyl 0.5 μg/kg body weight will be given and 15° passive elevation ofaffected limb will be re-attempted after 5 minutes. If still NRS score is ≥4then Inj. fentanyl 0.5 μg/kg body weight will be repeated every 5 minutes up tomaximum of 3 doses.

  1. Patient will be made tosit up for positioning for subarachnoid block after NRS score on 15 degreepassive limb elevation is < 4 or after 3 doses of fentanyl have been givenand NRS pain score  will be noted onsitting up the patient for positioning for subarachnoid block.

  2. Total amount of supplementalfentanyl if required for decreasing NRS pain score on 15° passive elevation of affectedlimb at 30 minutes after administration of block will be noted.

  3. The ease of spinal positioning (EOSP) will be assessed on the scale of 0–3 (0 = unable to position, 1 =patient had abnormal posturing due to pain and required support for positioning,2 = mild discomfort but does not require support for positioning, 3 = optimalcondition where the patient was able to position himself without pain).

  4. Quality of patientposition for subarachnoid block as assessed by anaesthesiologist performingsubarachnoid block will be evaluated as

0=Unsatisfactory,1=Satisfactory, 2=Good or 3=Optimal.

Subarachnoid  block will be performed using a median orparamedian approach at the L3-L4 or L4-L5 interspace using spinal needle using3 ml of 0.5% bupivacaine + fentanyl 10 µg.

  1. Heart rate, non invasiveblood pressure (systolic ,diastolic, Mean), respiratory rate and SpO2will be recorded ; a) at rest at 5, 10 ,20, 30 minutes after performing theblock procedure, b) on  15 degree passivelimb elevation at 30 minutes after performing the block and c) on positioning patient( in sitting up position ) for subarachnoid block.

Intraoperative monitoring of heart rate,noninvasive blood pressure (systolic, diastolic and mean) and SpO2 will bedone.

  1. Complications such ashypotension (a decrease of mean blood pressure >20% from preanaestheticbaseline values), bradycardia (HR <40 beats/min), hypoventilation (breathingrate <8 breaths/min), nausea and vomiting and signs of LA toxicity will benoted and treated. After surgery, all patients will be transferred to postanesthesia care unit, and hemodynamic parameters will be monitored. Allpatients will receive paracetamol 1gm intraveously 8 hourly.

9.Patient satisfaction scorewill be noted after positioning patient in sitting up position for subarachnoidblock:

Score 1- Good (Willdefinitely accept the block again in future if required).

Score 2- Poor (will neveraccept the block again in future if required).

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Study will be conducted in patients in age group of 18 to 80 years belonging to American society of Anaesthesiologist (ASA) physical status I and II scheduled for Hip fracture surgery under Subarachnoid block.

排除标准

  • Patients who can sit comfortably without requirement of analgesia Patients having contraindication for Subarachnoid block Patients with known allergy to local anesthetic drugs Patients with Pre-existing peripheral nerve neuropathies and having fractures in multiple bones Patients receiving chronic analgesic Therapy Patients with infection over injection site.

结局指标

主要结局

Compare Analgesia provided by ultrasound guided pericapsular nerve group block with that of suprainguinal fascia Iliaca block measured by numerical rating scale score on passive limb elevation of 15 degrees at 30 minutes post block in patients with hip fracture before positioning for subarachnoid block.

时间窗: Before the block & at 30 minutes after the block

次要结局

  • Total amount of supplemental fentanyl if required to reduce pain on 15 degrees limb elevation at 30 minutes after administration of block.(NRS score on positioning patient for subarachnoid block)

研究者

发起方
Prachi Ranjan
申办方类型
Other [self]

研究点 (1)

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