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临床试验/CTRI/2024/10/076060
CTRI/2024/10/076060尚未招募3 期

Comparison Between Ultrasound Guided Transversalis Fascia Plane block and Standard Wound Infiltration Technique On Postoperative Pain management in Patients with Inguinal Hernia Surgery- A Randomised Controlled Trial.

Ims And Sum Hospital Bhubaneswar1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2024年11月24日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
106
试验地点
1
主要终点
To compare Time to rescue analgesia

研究概览

简要总结

In this study 106 patients age between 15 to 60 years posted for inguinal hernia surgery.

Routine evalutions and investivations performed, patients are kept npo for 8 hours for solids and 4 hr for liquids. informed consent is obtined.

upon arrival in the oparating theater, standard ASA monitoring ( ECG, NIBP,SPO2). is establised. An 18 gauge IV cannula in inserted under aseptic condition  and ringer lactate infusion is started 5 ml /kg BW. Baseline vitals are recorded.

spinal anesthesia is administered at L4-L5 interspace using 25 G Quincke’s needle, with 2 ml of Bupivacaine 0.5% injected at arate of 2 ml/ second .

patient and outcome assessors are blinded to group allocation, with randomization done using computer generated numbers.

statistical analysis will be done by SPSS. sample size 106. in two group independent t test will be performed. p<0.5 is consider significant.

standard wound infiltration with 15 ml ropivacaine 0.2% or a TFP block is performed for TFP block ropivacaine in injected under USG guidance.

pain severity is evaluated by visual analogue scale (VAS) at specific time points post surgery . patient satisfaction is measured on a Linkert scale. Analgesic requests and total Diclofenac sodium requirements are recorded over 36 hours post surgery.

研究设计

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

入排标准

年龄范围
15.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients of age 15-60 years Pateints under ASA I and ASA II Elective inguinal hernia surgery Under spinal anaesthesia Non recurrent hernia surgeries.

排除标准

  • patients refusal patient age above 60 and less than 15 patient under asa 3 and 4 mallappati grading 3 and 4 patient having allergy to bupivacine patient having coagulopathies.

结局指标

主要结局

To compare Time to rescue analgesia

时间窗: 0,2,4,6,12,24,36 hours postoperatively

Post op pain at rest and movement by VAS Scores /Dynamic VAS Scores

时间窗: 0,2,4,6,12,24,36 hours postoperatively

次要结局

  • To compare patient satisfaction score (Linkert Scale).(Total Diclofenac sodium injection requirement .)

研究者

发起方
Ims And Sum Hospital Bhubaneswar
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Gour kishore Chakraborty

IMS AND SUM HOSPITAL

研究点 (1)

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