Comparison of Infiltration of 2% Lidocaine With and Without Needle as Analgesia in Epidural Needle Insertion
Condition: Epidural; Anesthesia, Headache; Analgesia
MeSH terms: Headache
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): Infiltration of 2% Lidocaine with Needle; Infiltration of 2% Lidocaine without Needle
Intervention type(s): Device; Device
Intervention description(s): Infiltration of 2% Lidocaine with Needle; 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
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Lidocaine infiltration; Epidural needle insertion; Epidural anesthesia.