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临床试验/CTRI/2021/03/032013
CTRI/2021/03/032013尚未招募不适用

A PERIPFERAL NERVE STIMULATOR GUIDED POPLITEAL SCIATIC NERVE BLOCK COMBINED WITH ADDUCTOR CANAL BLOCK IN LOWER LEG SURGERY-AS A SOLE ANESTHETIC TECHNIQUE

SSG HospitalVadodara1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月4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
60
试验地点
1
主要终点
1 Onset and Duration of Sensory and Motor block

研究概览

简要总结

The study will be a typeof prospective randomised controlled trial undertaken in adult patients of 18to 70 year of age admitted in SSG hospital requiring lower leg surgery with asample size of 60 patients.

Pre-operativePreparation:

•Patient to be kept nil by mouth(NBM) for minimum 6-8 Hours.

•Patient will be explained about VAS score preoperatively.

•Operation theatre preparation for all necessary equipments and drugs to be keptready.

•Anesthesia machine with monitor to be kept ready.

•IV line will be taken with 18G cannula.

Premedication**:-**

ON THE DAY BEFORESURGERY

Tab Ranitidine 150 mg PO 1 HS

ON THE DAY OF SURGERY

5 Minutes before induction:

Inj.Glycopyrrolate 0.2 mg IV

Inj.Ondansetron 4 mg IV

Anesthesiamethod:

INDUCTIONOF ANAESTHESIA:

Thepatients will be randomly allocated into two groups by sealed envelope method.

Groupingof Patients:

•Group P(N=30)

Patientswill be given Popliteal Sciatic Block  +Adductor Canal Block (Drug to be used:- 0.5% Bupivacaine  20 ml + 2% Lignocaine 20ml with 5mcg/ml1:200000 Adrenaline and Sodabicarbonate 2ml)

•Group S(N=30)

Patientswill be given Unilateral Spinal Anesthesia with Inj. Bupivacaine Heavy 0.5%1ml.

Ø  Injection Midazolam 1mg/kgwill be given inall the patients after procedure.

 TechniqueFor Popliteal Sciatic Block:-

Position:Supine with Hip Flexed at 30* by putting pillow below the heel and Knee FullyExtended.

Thelandmark for needle insertion is approximately 10cm above the Most Prominentpart of Lateral Femoral Condyle in the groove between Biceps Femoris  and the vastus Lateralis muscle.

 NerveLocator Technique: In proposed study we will use this technique.

•A22-gauge 8-inch insulated needle is attached to the negative electrode of thePNS. The extension tubing is primed and attached to a syringe filled with localanesthetic solution.

•Theinitial current strength is set at 3mA with 2Hz frequency and 0.1ms duration.

•The needle is inserted in the groove between the Biceps Femoris and Vastuslateralis by palpating it with finger tips and is directed perpendicular to theskin till the Planter Flexion of Foot is elicited.

•Amplitude to be decreased up to 0.5 mA while seeking maximal Planter Flexioncontraction. If necessary needle should be relocated to achieve adequatecontraction while reducing amplitude. If there is continued Planter Flexioncontraction when at 0.2 mA or less withdraw needle. Stimulation at this lowlevel may indicate intraneural placement of the needle.

•After the injection of 1 ml of local anesthetic the contractions should startto fade.

•Always aspiration should be done before injection, during injection and afterinjection to ensure that inadvertent intravascular injection has not occurred.If the aspiration for blood is negative, 21ml local anesthetic is injected.

•If the patient experiences excruciating pain or parasthesia with injectionwithdraw the needle slightly.

•Complete effect of the block will be achieved in 20 minutes.

TechniqueFor Adductor Canal Block

Position:Supine. A pillow will be placed under the knee and thigh.

Thelandmark for needle insertion is approximately 4 finger breadth (7 -8 cm) abovethe adductor tubercle on the medical condyle of the femur in the groove betweenSartorius and the vastus medialis muscle

Thegroove is also known as the Jobert’s fossa.

 NerveLocator Technique: In proposed study we will use this technique.

•A22-gauge 8-inch insulated needle is attached to the negative electrode of thePNS. The extension tubing is primed and attached to a syringe filled with LAsolution.

•Theinitial current strength is set at 3mA with 2Hz frequency and 0.1ms duration.

•Theblock is best done by standing on the opposite side to the block site.

•The needle is inserted in the groove between the vastus medialis and Sartoriusby palpating it with finger tips and is directed perpendicular to the skin withslight posterior angulation till the contraction of vastus medialis muscle iselicited.

•Amplitude to be decreased up to 0.5 mA while seeking maximal vastus medialiscontraction. If contractions are fading while reducing amplitude, needle shouldbe relocated to achieve adequate contraction. If there is continued vastus medialis contraction when at 0.2 mA or lesswithdraw needle. Stimulation at this low level may indicate intraneuralplacement of the needle.

•After the injection of 1 ml of local anesthetic the contractions should startto fade.

•Always aspiration should be done before injection, during injection and afterinjection to ensure that inadvertent intravascular injection has not occurred.If the aspiration for blood is negative, 21ml local anesthetic is injected.

•If the patient experiences excruciating pain or paresthesia with injectionwithdraw the needle slightly.

•Complete effect of the block will be achieved in 20 minutes.

 TechniqueFor Unilateral Spinal anesthesia

Position:Lateral (Operative site to be in lower side)

Under all aseptic and antisepticprecaution spinal anesthesia should be given in L3-L4 space with 23G spinalneedle with injection 0.5% Bupivacaine Heavy 1ml. Patient kept in lateralposition for 10 minutes.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1 Age Group – 18-70years of either sex.
  • 4 Malampatti Grade- I / II 5 Duration of Surgery Less than 2 hrs.
  • 6 Patient posted for lower leg surgeries (e.g. orthopedic surgeries: foot, ankle, distal tibia; PVD surgeries: tarsal and metatarsal amputations and debridement etc.) 7 Patient able to give written & informed consent.

排除标准

  • 1 Patient not willing for procedure.
  • 2 Patients with coagulopathy, local infection, pre- existing neuropathy, head injury.
  • 3 Patient having contraindication for spinal anesthesia.
  • 4 Hypersensitivity to local anesthetic drug.
  • 5 Patients with significant h/o drug or alcohol abuse, psychiatric illness.

结局指标

主要结局

1 Onset and Duration of Sensory and Motor block

时间窗: Patient will be Monitored for above mantion Parameters immediately after block,at 5 minute interval for first 10 min,at 10 minute interval for 1 hour and at 20 minute interval for next 1 hour.

3 Vital Parameters

时间窗: Patient will be Monitored for above mantion Parameters immediately after block,at 5 minute interval for first 10 min,at 10 minute interval for 1 hour and at 20 minute interval for next 1 hour.

2 Evaluation of block for satisfactory anesthesia

时间窗: Patient will be Monitored for above mantion Parameters immediately after block,at 5 minute interval for first 10 min,at 10 minute interval for 1 hour and at 20 minute interval for next 1 hour.

4 Total duration of analgesia

时间窗: Patient will be Monitored for above mantion Parameters immediately after block,at 5 minute interval for first 10 min,at 10 minute interval for 1 hour and at 20 minute interval for next 1 hour.

次要结局

  • •Perioperative complications

研究者

发起方
SSG HospitalVadodara
申办方类型
Government medical college

研究点 (1)

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