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临床试验/NCT05326867
NCT05326867已完成不适用

Comparison of Infiltration of 2% Lidocaine With and Without Needle as Analgesia in Epidural Needle Insertion

Indonesia University2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
2
主要终点
Pain Scale (NPRS scale) when Lidocaine Infiltrated

研究概览

简要总结

One way to reduce pain during epidural needle insertion is infiltration of lidocaine using a needle. However, infiltration of lidocaine using the needle alone is a painful process. Free needle infiltration of lidocaine can be an alternative to reduce epidural needle insertion pain. The study of Gozdemir et al. found that 10% lidocaine infiltration without needle was less painful than 2% lidocaine infiltration with a 27G needle with no significant difference in analgesia effect during epidural needle insertion. This study aimed to compare infiltration of lidocaine with and without needle for epidural needle insertion in a double-blind study, using a Tuohy needle, Comfort-inTM injector, and wider surgical group as novelty from previous studies.

This study was a double blind randomized controlled trial. Data collection was carried out consecutively on 84 subjects with 42 subjects in each group of lidocaine infiltration without needles and lidocaine infiltration with 23G needles. The effectiveness of analgesia was assessed from three variables like pain with a Numeric Pain Rating Scale (NPRS) of 0 to 10 during lidocaine infiltration, pain with NPRS during epidural needle insertion, and patient movement during epidural needle insertion.

详细描述

Pain control is an important aspect in patient who will undergo a medical procedure. Reducing pain will not only improves patient satisfaction and comfort, but also provide speedy and easy medical procedures application. One of the patient's concerns regarding Anesthesia is pain when needles injected intracutaneously, intramuscularly, intravenously, or intrathecally. Epidural anesthesia is one of the neuraxial block technique resulting in sympathetic, sensory, and motor block depending on the dose, concentration, and volume of the local anesthetic administered. Epidural anesthesia was performed in 118 cases (18%) of the total 672 anesthesia cases in November 2020 at the National Central General Hospital (RSUPN) Cipto Mangunkusumo. Tuohy Type is one of epidural needles commonly used in Epidural anesthesia at Cipto Mangunkusumo General Hospital. This needle's size is large enough so that it causes pain if local anesthetic is not given prior to insertion. One of the way to administer local anesthetic prior to epidural needle insertion is by skin infiltration using a needle.

Ramzi in his research found that the median Visual Analogue Scale (VAS) due to epidural needle insertion given lidocaine infiltration with a needle is 5 with a range of 0-10. Mogensen investigated differences in pain expectations and the actual pain experienced by the patient due to insertion of the Tuohy needle in epidural anesthesia infiltrated with lidocaine using a needle. The research found that the median Numeric Rating Scale (NRS) for pain expectations was 5 while the NRS for actual pain experienced by patients was 2 (p value < 0.0001). Infiltration of local anesthetic with the needle alone is painful. Gozdemir in his research found that the pain median due to infiltration lidocaine using the needle before insertion of the epidural needle was 2 with a range of 0 up to 4.

Several alternative methods have been developed to reduce the pain of local anesthetic infiltration prior to epidural needle insertion, such as: establishing good communication with the patient during the procedure, replacing local anesthetic agents with chloroprocaine, adding bicarbonate to make lidocaine pH close to physiological pH, cooling down the skin with cryoanalgesia, local anesthetic infiltration with a smaller needle (25-30 G needle), lidocaine patch, and Eutectic Mixtures of Local Aesthetics (EMLA). Some of these alternatives still perform needle punctures that can produce pain, although to a lesser degree, and 10% of the population have a needle phobia. Non-invasive alternatives such as EMLA or cryoanalgesia cannot be a thorough solution due to the depth of analgesia generated. A study stated that the depth from skin to lumbar epidural cavity in parturient is 2-9 cm with 89% being on the 3.5-7.5 cm intervals. In leaner patients, the depth of the lumbar epidural found at 2-4 cm. Whereas EMLA only provides analgesia in depth of 2.9-4.5 mm if EMLA is applied for 60-120 minutes and 6 mm if applied for 3-4 hours. While cryoanalgesia such as vapocoolants spray works as a temporary topical analgesia by cooling the skin thereby reducing the sensitivity of pain receptors.

Needle usage, the length of time it takes to produce analgesia, transient analgesia results, and lack of depth of analgesia are the problems to present an alternative to local anesthetic infiltration that is completely pain free and adequate. A needleless injection technology can be a solution to these problems. The medicinal liquid is injected by a tool with high speed and pressure through a smooth hole. This system is expected to make the analgesia condition can be achieved quickly, painlessly, and avoiding needle phobia

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

Participants, care providers, and investigators are blinded

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective surgery patients undergoing epidural anesthesia (from thoracic 11 to lumbar 5) at Cipto Mangunkusumo General Hospital
  • Patients aged 19 to 65 years
  • Patients with American Society of Anaesthesiologist (ASA) criteria 1 to 3
  • Willing to participate and signing the agreement

排除标准

  • Epidural anesthesia with combined spinal epidural needle (Espocan)
  • Epidural anesthesia is contraindicated
  • Patients with a history of local anesthetic allergy
  • The patient who cannot sit or feels pain when in a sitting position

结局指标

主要结局

Pain Scale (NPRS scale) when Lidocaine Infiltrated

时间窗: Immediately after Lidocaine is infiltrated

The pain measurement with NPRS scale when 2% Lidocaine infiltrated

Pain Scale (NPRS scale) when Epidural Needle Inserted

时间窗: Immediately after Epidural Needle Inserted

The pain measurement with NPRS scale when Epidural Needle Inserted

Patient's Movement when Lidocaine Infiltrated

时间窗: Immediately after Lidocaine is infiltrated

Observation of patient's movement when 2% Lidocaine infiltrated

Patient's Movement when Epidural Needle Inserted

时间窗: Immediately after Epidural Needle Inserted

Observation of patient's movement when Epidural Needle Inserted

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Raden Besthadi Sukmono

Anesthesiologist

Indonesia University

研究点 (2)

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