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临床试验/CTRI/2026/01/100657
CTRI/2026/01/100657尚未招募4 期

A Comparative Study of Eutectic Mixture of Local Anaesthetic Cream ( EMLA) and Lignocaine Patch ( 5%) to Alleviate Pain on Needle Insertion During Spinal Anaesthesia in a Tertiary Care Centre

Sapthagiri Institute of Medical Sciences and Research Centre1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年1月19日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Pain score on spinal needle insertion using Visual Analogue Scale (VAS)

研究概览

简要总结

Spinal anesthesia is commonly used for surgeries of the lower limbs, pelvis and abdomen. The insertion of the spinal needle can cause discomfort and anxiety in many patients despite the overall good tolerance of the procedure. To reduce the pain of needle puncture, topical local anesthetics can be applied to the skin before spinal anesthesia.

Eutectic Mixture of Local Anaesthetic cream containing 2.5 percent lignocaine and 2.5 percent prilocaine is widely used for skin anesthesia in pediatric venipuncture and lumbar puncture. Lignocaine patch 5 percent has been shown to reduce pain in conditions such as post herpetic neuralgia and painful diabetic neuropathy and is also effective in providing local analgesia.

This randomized controlled study aims to compare the effectiveness of EMLA cream and 5 percent lignocaine patch in alleviating pain during spinal needle insertion. Ninety adult patients undergoing elective surgery under spinal anesthesia will be randomly allocated into two groups to receive either EMLA cream or lignocaine patch at the puncture site prior to the procedure. Pain during spinal needle insertion will be assessed using the Visual Analogue Scale. The primary outcome is the difference in pain scores between the two groups and secondary outcomes include ease of needle insertion and patient satisfaction. The study will be conducted at Sapthagiri Institute of Medical Sciences and Research Centre Bangalore.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • 1 Patient posted for infra umbilical surgical procedure under spinal anesthesia.
  • 2 Age 18-60 years.
  • 3 ASA grade I & II.
  • 4 Weight of the patient 45-70 kgs.
  • 5 Patient who consent for the procedure.

排除标准

  • 1 Patient not willing to participate in the study.
  • 2 Contraindication for spinal anesthesia.
  • 4 Pregnant women or lactating women 5 More than three attempts of spinal needle insertion.

结局指标

主要结局

Pain score on spinal needle insertion using Visual Analogue Scale (VAS)

时间窗: Immediately after spinal needle insertion

次要结局

  • measuring patient satisfaction, hemodynamic response, adverse effects(At the time of needle insertion, 5minutes, 10 minutes & 15 minutes after insertion)

研究者

发起方
Sapthagiri Institute of Medical Sciences and Research Centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr. Narendra Babu M. C.

Sapthagiri Institute of Medical Sciences and Research Centre,Bangalore

研究点 (1)

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