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临床试验/CTRI/2020/02/023104
CTRI/2020/02/023104尚未招募不适用

COMBINED PSOAS COMPARTMENT BLOCK AND SCIATIC NERVE BLOCK VERSUS UNILATERAL SUBARACHNOID BLOCK AS A SOLE ANAESTHETIC TECHNIQUE FOR LOWER LIMB ORTHOPAEDIC SURGERY

ssg hospital1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2020年7月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
ssg hospital
入组人数
96
试验地点
1
主要终点
Duration of analgesia(in hours)

研究概览

简要总结

COMBINED PSOASCOMPARTMENT BLOCK AND SCIATIC NERVE BLOCK VERSUS UNILATERAL SUBARACHNOID BLOCKAS A SOLE ANAESTHETIC TECHNIQUE FOR LOWER LIMB ORTHOPAEDIC SURGERY – A PROSPECTIVERANDOMISED CONTROLLED STUDY

PURPOSE - Our purpose of the study is to compare the quality of anaesthesiaand hemodynamic changes of combined psoas compartment block and sciatic nerveblock as a sole anaesthetic technique with that of unilateral subarachnoidblock for patients undergoing lower limb orthopaedic surgeries.

AIM-The aims of the study are :To compare combined psoas compartment and sciaticnerve block with subarachnoid block in terms of following parameters

1.Sensory block :

·        Onsettime

·        Peakeffect

·        Durationof sensory block

  1. Motorblock :

·        Onsettime

·        Peakeffect

·        Durationof motor block

3.Vitalparameters:

  1. Peri-operativecomplication

  2. Durationof analgesia

  3. Number ofrescue analgesic required within 24 hrs

Group(P):     (n=48)

In this group patients will begiven combined psoas compartment block and sciatic nerve block.

Group(S):    (n=48)

In this group patients will be given unilateral subarachnoidblock.

Psoas compartment block :

·        The block will be given in lateralposition. Surgical side leg will be in the nondependent position.

·        Two points will be marked – posteriorsuperior iliac spine (PSIS) and Intercristal line.

·        Linewill be drawn from the PSIS parallel to the spine and another line isintercristal line.

·        Pointof intersection of the two lines is the point of needle insertion.

·        Underall aseptic precaution 100mm 22 gauze insulated needle connected to nervelocator set at 3mA frequency will be inserted at this point. When the needleenters in the psoas compartment quadriceps motor response will be seen. Adequateproximity to the nerves will be assured by continued twitching after reducingthe stimulation to 0.5mA. After negative aspiration 25ml local anaestheticsolution will be injected.

Sciaticnerve block:

·        The sciatic nerve block will beperformed by classical Labat’s approach. The patient with same lateraldecubitus position (Sim’s position)

·        Two lines will be drawn: the firstfrom the greater trochanter to the sacral hiatus and second from greatertrochanter to the posterosuperior iliac spine (PSIS). A perpendicular will bedrawn from the midpoint of the greater trochanter‑PSIS line, caudad thatintersected the greater trochanter‑sacral hiatus line, which represent theinsertion point.

·        Under all aseptic measures theinsulated needle will be connected to nerve stimulator set at 3 mA, and will beinserted at right angles to the skin to elicit a motor response like planterflexion. Adequateproximity to the nerves will be assured by continue twitching after reducingthe stimulation to 0.5mA.

·        Afternegative aspiration 25ml local anaesthetic solution will be injected.

 

  1 min

2 min

3  min

5  min

10 min

15 min

20 min

25

min

30 min

|sensory

Onset

          | Peak effect

          |motor

Onset

          | Peak effect

Post-operativeMonitoring of Patient:

Effect of Sensory block andpost-operative analgesia (Visual Analogue Score – VAS) will be assessed every1hr for first 6 hours, every 2 hour for next 6 hours and then at 18 and 24hours.

1hr

2hr

3hr

4hr

5hr

6hr

8hr

10hr

12hr

18 hr

24 hr

|Sensory block

|Motor block

|Analgesia

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

  • 18 to 70 years of age either sex asa grading I II III patient with planned lower limb orthopedic surgery patient able to understand VAS score.

排除标准

  • patient not willing allergy to local anaesthetic contraindivcation of spinal anaesthesia patirnt with coagulopathy neurological deficit local infection and significant history of alcohol or drug abuse, psychiatric illness bilateral lower limb surgery, patient with pelvic fracture.

结局指标

主要结局

Duration of analgesia(in hours)

时间窗: duration of analgesia in case of psoas compartment block and sciatic nerve block versus spinal anaesthesia will be assessed upto 24 hours postoperatively

次要结局

  • Onset time, peak effect, duration of sensory block(Onset time, peak effect and duration of motor block)

研究者

发起方
ssg hospital
申办方类型
Government medical college

研究点 (1)

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