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临床试验/CTRI/2022/08/044614
CTRI/2022/08/044614已完成不适用

Comparative evaluation of analgesic efficacy of topical EMLA cream with local infiltration of 2% lignocaine prior to subarachnoid block.

Pandit BD Sharma PGIMS Rohtak1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年8月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
•Primary objective - To compare the VAS score and 4-point pain score of topical EMLA cream with Lignocaine infiltration during subarachnoid block.

研究概览

简要总结

Spinal anaesthesia is a simple, fast, safe and reliable method for surgery of the lower body that provides profound sensory and motor block by a single use of spinal needle to administer local anaesthetics into the subarachnoid space.1It is usually administered in the lumbar region in L3-L4 or L4-L5 space. The main reasons for rejecting neuraxial blocks are fear of needle, backache as well as anticipated immediate pain associated with lumbar puncture.2 Lumbar puncture requires more cooperation of the patients and may at times need multiple punctures which may cause pain and apprehensions in patients. Relieving the lumbar puncture pain not only increases the patient’s satisfaction and comfort, but also let the anaesthetist apply spinal puncture fast and easily.3

Lignocaine 2% solution is routinely used for infiltration of skin and subcutaneous tissues before lumbar puncture to reduce needle prick pain. Infiltration of local anaesthetics requires needle insertion which may itself cause acute pain and discomfort to the patient, may cause masking of anatomical landmarks which are used to identify the lumbar spaces and risks of accidental intravascular administrations.4 EMLA cream provides a non-invasive analgesia and has been effectively used in many studies to reduce needle prick pain.5,6

Eutectic mixture of local anaesthetics (EMLA) is an effective topical anaesthetic mixture containing lignocaine and prilocaine. The mixture is termed eutectic as it has a melting point lower than its individual components. The mixture is liquid at room temperature while the individual components are crystalline substances. EMLA is used for relieving the pain caused during venous and intra-arterial cannula insertions in paediatrics and adult patients, excision of cutaneous lesions, radiofrequency ablation of warts, fine-needle aspiration of thyroid nodules, minor surgical procedures such as during perineal repair after childbirth, for pain control during shockwave lithotripsy, humeral block placement in non-sedated patients, peribulbar injection, mammography, transrectal biopsy of prostate, hysterosalpingography, IUD insertions,  dental procedures, epidural injections and lumbar punctures.5,6

The purpose of this study is to find out the efficacy of topical EMLA cream in comparison to the standard infiltration technique in reducing pain of needle insertion during lumbar subarachnoid block and have better patient satisfaction level.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Investigator Blinded

入排标准

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

入选标准

  • Patients of the age 18-60 years, of either sex belonging to ASA grade I and grade II undergoing
  • elective lower abdominal surgery
  • pelvic surgery 3.lower limb surgeries will be selected.

排除标准

  • Following patients will be excluded 1.Patients allergic EMLA cream or any other local anaesthetics.
  • Pregnant and lactating females.
  • Patients with methaemoglobinaemia
  • Psychiatric disorders
  • Fractures
  • More than 3 attempts at lumbar puncture.

结局指标

主要结局

•Primary objective - To compare the VAS score and 4-point pain score of topical EMLA cream with Lignocaine infiltration during subarachnoid block.

时间窗: 1.VAS Score will be assessed immediately (within 5 minutes) after lumbar subarachnoid block on the scale of 0-10. | 2.the 4-point pain scale will be assessed at the time of spinal needle insertion as: | 0 – no response | 1 - mild facial grimace | 2 - verbal response | 3 - movement of the back

次要结局

  • Secondary objective -(1. Haemodynamic response to pain,)

研究者

发起方
Pandit BD Sharma PGIMS Rohtak
申办方类型
Government medical college

研究点 (1)

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