跳至主要内容
临床试验/CTRI/2024/09/074031
CTRI/2024/09/074031尚未招募不适用

Ultrasound guided Fascia Iliaca Compartment block comparing suprainguinal and infrainguinal approaches: A prospective randomized study.

Dr Rishabh Srivastava1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月30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
100
试验地点
1
主要终点
1) Pain experienced while sitting for spinal anesthesia

研究概览

简要总结

After obtaining institutional ethical committee approval, written and informed consent will be taken from the patient.

The study will be conducted in 100 patients between 18 to 80 years of age, ASAI and ASA-II of either gender undergoing femur fracture surgeries under subarachanoid block.

Patients will be randomly allocated into one of the following groups of 50 patients each using a computer-generated random number table:

Group S – USG guided Suprainguinal FICB with 30 mL 0.2% ropivacaine

Group I – USG guided Infrainguinal FICB with 30 mL 0.2%

All the patients in the study will be subjected to a thorough pre-anaesthetic evaluation which includes a detailed history taking, complete general physical examination, systemic examination, and necessary relevant investigations like complete blood count, blood urea, serum creatinine, chest X-ray, ECG, bleeding time, clotting time, random blood sugar, and urine analysis (Sugar, Albumin, and Microscopy).

All patients will be kept nil per oral according to standard guidelines. Tablet Alprazolam 0.5 mg and Tablet Pantoprazole 40 mg will be given the day before surgery. Additionally, at 6 AM on the day of surgery, Injection Pantoprazole 40 mg will be adminstered intravenously. A suitable intravenous line will be secured for the administration of fluids and drugs. Preoperatively, the Numerical Rating Scale will be explained to the patient, and the intensity of pain will be evaluated on a scale of 0 to 10. A score of 0 indicates no pain, while a score of 10 indicates worst pain imaginable.

The patient will be shifted to pre-operative room and multiparameter monitor will be connected and pre-operative heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, respiratory rate, oxygen saturation, ECG will be recorded and intravenous fluids will be connected.

All patients will undergo either the suprainguinal or infrainguinal approach in the Fascia Iliaca Compartment block, based on their assigned group. The procedure will be conducted by an experienced anesthesiologist. Needle visualization, anatomical visualization of structures, duration taken to give block, area of drug spread will be noted and a blinded observer will assess postoperative pain scores and 24-hour tramadol injection consumption.

The patient will be positioned in the supine position, and the area over the inguinal crease will be prepared using aseptic techniques, followed by disinfection with povidone iodine. Ultrasound-guided fascia iliaca compartment block will be performed on patients according to their assigned groups.For patients in Group S, the fascia iliaca compartment block will be performed using an ultrasound-guided suprainguinal approach. A high-frequency (6–14 MHz) linear probe of GE LOGIC C5 PREMIUM USG machine will be used to locate the femoral artery in the short axis by palpating the anterior superior iliac spine (ASIS). The sartorius muscle will then be identified and traced cephalad to its insertion on the ASIS. The ultrasound probe will be positioned to visualize the iliacus muscle, and a 20G x 1, ½” inch hypodermic needle will be advanced in-plane to puncture the fascia iliaca. Confirmation of needle tip location will be achieved by injecting 2 mL of local anesthetic, followed by incremental injection of 30 mL of 0.2% ropivacaine superficial to the iliacus muscle and deep to the fascia iliaca. The spreading of the local anesthetic will be confirmed by observing caudomedial spreading toward the femoral nerve.

For the infrainguinal approach, the patient will remain in the supine position, and a high-frequency (6–14 MHz) linear probe will be used to locate the femoral artery transversely at the inguinal crease. The femoral nerve and fascia iliaca will be identified, and a blunt-ended needle will be inserted using an in-plane technique beneath the fascia iliaca around the lateral third of a line between the ASIS and pubic tubercle. Confirmation of needle placement will be followed by incremental injection of 30 mL of 0.2% ropivacaine. Placement will be confirmed by observing the separation of the fascia iliaca from the iliopsoas muscle and the spreading of local anesthetic toward the femoral nerve medially and iliac crest laterally.

The sensory block will be defined as time from the end of injection to dull response to pin prick, and peak sensory effect was defined as time from the end of injection to no response of pin prick.

PAIN SCORE : NRS (Numerical Rating Scale)

Patients will be asked to select a number between 0 and 10 that best represents their pain intensity.

When the NRS score reaches < 4, the patient will be shifted to the operating theatre, where a multiparameter monitor will be connected. The patient will then be positioned in a sitting position for spinal anesthesia. If any patient reports pain with a score greater than 4 during positioning, they will be excluded from the study, as it may indicate a potential failure of the nerve block.

Under all aseptic precautions, spinal anaesthesia will be given in L3-L4 space using appropriate Quincke Babcock’s spinal needle. After clear CSF flow, 3 ml of Inj. Bupivacaine heavy 0.5% will be administered, and patient’s vitals will be monitored.

Any side effects and complications will be noted and treated. If SBP falls below 20% of baseline or reaches 90 mmHg , it is treated with IV fluids and Inj.Mephentramine 6mg/I.V. if pulse rate reaches less than 60 beats per minute, Inj. Glycopyrrolate 0.2 mg/I.V will be given. After the completion of surgery, the patient will be transferred to the recovery room and monitored every hour until the NRS score exceeds 4. When the NRS score is greater than or equal to 4, rescue analgesia with Inj. Tramadol 100 mg in 100 ml normal saline will be administered.

After the completion of surgery, the patient will be transferred to the recovery room and monitored every hour until the NRS score exceeds 4. When the NRS score is greater than or equal to 4, rescue analgesia with Inj. Tramadol 100 mg in 100 ml normal saline will be administered.

Duration of analgesia: Time taken from completion of FICB to when NRS score reaches more than or equal to 4.

The presence of any side effects such as bradycardia, hypotension, tachycardia, nausea, vomiting, hematoma, infections, and post-block neuropathy will be noted.

Statistics: Statistical test: The collected data from questionnaire will be coded and manually entered into the computer for statistical analysis. Statistical analysis will be done by using: 1) Unpaired t-test: It is used for test for Significance. If P value < 0.05 will be considered for statistically significant @ 95% level of significance. 2) Inferential Statistics: Percentages, means, Standard deviation will be calculated. Results will be expressed in the form of graphs and tables.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • Age- 18 to 80 years of either gender.
  • Patients belonging to ASA Physical Status I and II.
  • Patients undergoing elective femoral fracture surgery.

排除标准

  • Patients refusal for the procedure.
  • Patients with history of allergy, sensitivity or any kind of reactions to local anaesthetic agents.
  • Patients with bleeding disorders or any significant coagulopathies and other contraindications for regional anesthesia.
  • Infection of the skin at the injection site.
  • Any lesion obscuring sonoanatomy.
  • Patients with pre-existing significant systemic diseases.
  • Patients on anticoagulants.
  • Patients with psychiatric illness.
  • Patients receiving combined spinal-epidural for lower limb surgeries 10) Inability to comprehend NRS scale.

结局指标

主要结局

1) Pain experienced while sitting for spinal anesthesia

时间窗: Postoperative analgesia- Pain will be assessed using pain score: Numerical Rating Scale at 2nd, 4th, 6th, 8th, 10th, 12th, 14th, 16th, 18th, 20th, 22nd and 24th hour postoperatively.

2) Postoperative analgesia

时间窗: Postoperative analgesia- Pain will be assessed using pain score: Numerical Rating Scale at 2nd, 4th, 6th, 8th, 10th, 12th, 14th, 16th, 18th, 20th, 22nd and 24th hour postoperatively.

次要结局

  • Visualization of needle (whole length/ partial length)(This will be noted while giving block.)
  • Anatomical visualization of structures (good/poor)(This will be noted while giving block.)
  • Duration taken to give block(This will be noted while giving block.)
  • Area of drug spread achieved(This will be assessed immediately after giving block.)
  • Duration of sensory block(The sensory affect will be assessed immediately after giving block & noting the onset time, which is time for the end of the injection to dull response to pin prick, & noting the peak time, which is time for the end of the injection to no response to pin prick.)
  • Time to rescue analgesia(This will be assessed in the postoperative period.)

研究者

发起方
Dr Rishabh Srivastava
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Rishabh Srivastava

Navodaya Medical College, Hospital And Research Centre

研究点 (1)

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