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临床试验/CTRI/2025/02/080529
CTRI/2025/02/080529尚未招募不适用

Comparison of analgesic efficacy among pericapsular nerve group block(PENG) fascia iliaca compartment block (FICB) and femoral nerve block (FNB) for positioning during subarachnoid block in proximal femur fractures - a hospital based a randomized controlled trial

AMITA MALLANNA HIPPARAGI1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年2月25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
90
试验地点
1
主要终点
PAIN ASSESSMENT BEFORE AND AFTER GIVING THE PENG FICB AND FNB FOR POSITIONING DURING SUBARACHNOID BLOCK IN PROXIMAL FEMUR FRACTURES

研究概览

简要总结

Hip and neck of femur fractures are the most commonly occurring serious injuries in older people where the need for emergency anaesthesia and surgery increases and account for the most common cause of death following accident. Upto 50-70% of patients record severe to very severe pain on pain scoring in the first 24 hours following hip fractures.

Severe pain encountered during positioning for spinal anaesthesia can worsen the patient experience psychologically and physically . Regional blocks facilitate patient positioning for spinal anaesthesia like the Fascia Iliaca Compartment Block, Pericapsular Nerve Group Block for efficacious pain control.

Primary Objective : Assessment of pain after PENG Block or FICB or FNBat the time of positioning for spinal anaesthesia in proximal femur fractures.

**Inclusion Criteria :**Age 18 years and above.

Patients undergoing fixation of femur fractures surgeries under spinal anaesthesia.

Either sex.

Patients willing to give consent.

Exclusion Criteria : Hypersensitivity to local anaesthesia.

Pre-existing respiratory, cardiovascular, neurological, renal disorders.

Alcohol or drug abuse.

Patients who do not fulfil inclusion criteria.

Study Protocol :

After obtaining the approval of ethical committee and written informed consent, a total of 90 patients (30 in each group) undergoing surgery under regional anaesthesia will be included in the study. Patients will be randomised  based on computer generated randomization table into one of the three groups.

After confirming NBM status prior to the block pain score assessed by visual analogue scale and vitals monitored, block is given 30 minutes before the surgery.

**Group P :**Will be receiving PENG Blockwith **15ml of 0.75% Ropivacaine.**A curvilinear low frequency ultrasound probe is placed over the line parallel to the inguinal ligament , rotated 45 degree to identify the anterior inferior iliac spine, the iliopubic eminence and psoas tendon. A 22 gauge needle is inserted in an in-plane approach to place the tip between pubic ramus posterior and psoas tendon anterior using hydrodissection technique.  Following negative aspiration a total volume of 15ml of ropivacaine (0.75%) injected.

**Group F :**Will be receiving FICB with **15ml of 0.75% Ropivacaine.**A linear ultrasound probe placed over the inguinal ligament in saggital plane, inferior medially to anterior superior iliac spine. Identify the bow tie sign formed by sartorius and the internal oblique muscle by sliding medially and rotating probe.  A 22 gauge needle introduced 1cm cephalad to the inguinal ligament to place the needle tip in the space between the internal oblique and iliacus muscles using hydrodissection technique. A total volume of 15ml of ropivacaine (0.75%) injected after negative aspiration.

Group FN : Will be receiving FNB with 15ml of 0.75% Ropivacaine. A linear ultrasound probe placed over femoral crease moved in lateral- medial direction to identify the artery. A 22 gauge needle introduced in an in-plane technique to nerve block the femoral nerve at the femoral crease. A total volume of 15ml of ropivacaine (0.75%) injected after negative aspiration.

Pain scores will be assessed after 30 minutes of giving the block to the patient using visual analogue scale before spinal anaesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • AGE 18 YEARS AND ABOVE PATIENTS UNDERGOING FEMUR FRACTURE SURGERIES UNDER SPINAL ANAESTHESIA EITHER SEX PATIENTS WILLING TO GIVE CONSENT.

排除标准

  • HYPERSENSITIVITY TO LOCAL ANAESTHESIA PRE EXISTING RESPIRATORY CARDIOVASCULAR NEUROLOGICAL RENAL DISORDERS ALCOHOL OR DRUG ABUSE.

结局指标

主要结局

PAIN ASSESSMENT BEFORE AND AFTER GIVING THE PENG FICB AND FNB FOR POSITIONING DURING SUBARACHNOID BLOCK IN PROXIMAL FEMUR FRACTURES

时间窗: HEMODYNAMIC MONITORING FOR 30 MINUTES AFTER GIVING THE BLOCK

次要结局

  • HEMODYNAMIC MONITORING(HEMODYNAMIC MONITORING FOR 30 MINUTES AFTER GIVING THE BLOCK)

研究者

发起方
AMITA MALLANNA HIPPARAGI
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR AMITA MALLANNA HIPPARAGI

DEPARTMENT OF ANAESTHESIOLOGY KLE UNIVERSITY JNMC NEHRU NAGAR BELGAUM

研究点 (1)

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