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临床试验/CTRI/2020/09/027893
CTRI/2020/09/027893尚未招募不适用

A Randomized Control Study To Compare The Efficacy Of Pre-Emptive Ultrasound Guided Fascia Iliaca Compartment Block With Pericapsular Nerve Group Block For Positioning Of Spinal Anaesthesia In Hip Fracture Surgeries

SRM Medical College Hospital And Research Centre1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年9月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Comparison of quality of positioning for spinal anaesthesia for hip fracture surgeries

研究概览

简要总结

Patients who met the inclusion criteria will be randomly allocated into two groups, Group A and Group B with  30 in each group based on computer generated random envelope method. Group F patients will receive 30 ml of 0.5% Ropivacaine for FICB (Fascia iliaca compartment block)  and Group P patients will receive PENG block.

All patients will receive premedication with tablet alprazolam 0.5 mg per oral 2 hours before shifting to the operating theatre. Once the patient is shifted to premedication room, the patient’s vitals were monitored using pulse oximetry, NIBP and ECG. After taking proper aseptic precautions, under ultrasound guidance, Fascia Iliaca Compartment Block will be given using 30 ml of 0.5% ropivacaine on group F patients. Group P patients will receive PENG Block with 20 ml of 0.75% Ropivacaine. After 15 minutes of administration of the block in both the groups, the patients will be shifted to the operation theatre and spinal anaesthesia will be given  using 3 ml of 0.5% bupivacaine (heavy). Intra-operatively patient will be monitored for heart rate, blood pressure, oxygen saturation, input and output monitoring. All the patients will be postoperatively monitored in the  recovery room for 2 hours and then shifted to PACU . Post-operative pain will be assessed by visual analog scale (VAS). Supplementary analgesics i.e. Inj. Paracetamol 1000mg(IV) will be given if the patient had elicited a VAS score of 3 to 5 and Inj. Tramadol 100 mg (IV) will be given if the patient has a VAS score of more than 5. Total consumption of Paracetemol and Tramadol for 24 hours will be noted.

Patient positioning score during spinal anaesthesia was assessed depending on the patient’s sitting comfort during administration of spinal anaesthesia.

0 – not satisfactory,

1 – satisfactory,

2 – Good,

3 – Optimal.

VISUAL ANALOG SCALE:

The pain will be assessed by visual analog scale (VAS), measured at rest.

0 = no pain at all

1–2 = mild pain intensity

3–5 = moderate pain intensity

6–8 = severe pain intensity

9–10 = worst pain ever felt.

The duration of postoperative analgesia is defined as the time taken from the completion of FICB and PENG block to the first request for postoperative analgesia (VAS > 3).

If the patient has VAS of 3 to 5 then Inj. Paracetamol 1g IV will be given and for VAS>5, inj tramadol will be given. The total consumption of tramadol and paracetamol will be noted. The occurrence of any adverse effects like nausea, vomiting, itching and respiratory depression will be noted and treated accordingly

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
40.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • ASA 1 2 3 Patients admitted for elective and emergency hip fracture surgeries under spinal anaesthesia.

排除标准

  • patient refusal, any contra indication for spinal anaesthesia, infection at the site of block, allergy to local anaesthetic drugs or other medications used in the study, coagulopathy.

结局指标

主要结局

Comparison of quality of positioning for spinal anaesthesia for hip fracture surgeries

时间窗: From starting until end of performing spinal anesthesia

次要结局

  • 1)To evaluate the duration of post-operative analgesia(2)Requirement of post-operative analgesics for 24 hrs.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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