跳至主要内容
临床试验/CTRI/2024/07/071546
CTRI/2024/07/071546尚未招募Phase 3 4

A Prospective randomized control trial to assess the role of Tensor Fascia Lata Plane Block in addition to Fascia Iliaca Compartment Block (FICB) using ultrasound in patient undergoing proximal femur surgeries through lateral incision of thigh.

Christian Medical college vellore1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年8月10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
100
试验地点
1
主要终点
To assess postoperative pain between the targeted nerve block groups – Conventional fascia iliaca block versus Fascia iliaca + TFL Block for first 48 hours

研究概览

简要总结

The current practice in regional anesthesia for proximal femur surgeries with lateral incisions is the Fascia Iliaca Compartment Block (FICB) and the Pericapsular Nerve Group (PENG) block. The FICB is an anterior lumbar plexus block in which local anaesthetic is injected deep to the fascia iliaca with the aim of blocking the femoral nerve (FN) and lateral femoral cutaneous nerve (LFCN). The incisions for proximal femur surgeries also involve cutting through the tensor fascia lata (TFL) muscle which is supplied by the superior gluteal nerve which is a branch of the sciatic nerve, arising from the lumbosacral plexus. The superior gluteal nerve is not covered by the fascia iliaca block.By means of this thesis study, we aim to assess the benefits and feasibility of blocking the superior gluteal nerve by means of administering the Tensor Fascia Lata Plane Block in addition to FICB for proximal femur surgeries.

RECRUITMENT OF PATIENTS -During pre-anaesthetic check (Informed consent will be taken by

primary investigator, patient is randomised by double blinding technique before the procedure.

They are randomised into two groups GROUP A (Fascia Iliaca Compartment Block) and

GROUP B (Fascia Iliaca Compartment Block+ TFL Block)

Under sterile aseptic precaution the anterior and lateral regions of the thigh at the inguinal region and upper thigh will be painted and draped

The ultrasound linear, high frequency transducer probe will be draped with sterile cover and first placed at inguinal region.

The femoral vessels, illiacus and sartorius muscle will be identified. The probe will then be moved laterally till the tensor fascia lata muscle appears into view after sartorius insertion

The transducer will be moved further laterally and slightly downward the thigh to identify the fascial plane between the TFL and the gluteus Medius. The superior gluteal nerve along with its accompanying vessel – transverse branch of lateral circumflex femoral artery enters the TFL muscle through its lower border

At this point on the USG Sono anatomy .upon identifying the arterial pulsation at the lower border of the muscle ,the block needle will be inserted from the medial edge of the probe and advanced till the lower border of the TFL

Upon reaching this point, the probe is moved 0.5 – 1 cm cranially from the point of entry of the artery, and the drug will be injected after negative aspiration .The expected endpoints will be drug spread along tensor fascia lata and the gluteus Medius muscle

A single shot of 8-10 ml of 0.25% bupivacaine or 0.2% ropivacaine with 0.2mcg/kg of dexmedetomidine will be administered after confirmation of drug spread.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

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

入选标准

  • patients between the ages of 18 and 80 -ASA I, II, III -patients giving written and informed consent.

排除标准

  • patients unwilling to give consent -any surgeries involving the hip joint -patient with infection at the site of puncture -patients with known allergy to local anesthetics -patients without documented peripheral neuropathy -Patients with Clinical Frailty Scale greater than IV.

结局指标

主要结局

To assess postoperative pain between the targeted nerve block groups – Conventional fascia iliaca block versus Fascia iliaca + TFL Block for first 48 hours

时间窗: 48 hours

次要结局

  • -Requirement of rescue analgesia for first 48 hours(- Good safety profile)

研究者

发起方
Christian Medical college vellore
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

John Arun Kumar J

Christian Medical College

研究点 (1)

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