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Epidural; Anesthesia, HeadacheNCT05326867

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

A study testing Infiltration of 2% Lidocaine with Needle and Infiltration of 2% Lidocaine without Needle in people with Epidural; Anesthesia, Headache and Analgesia, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Epidural; Anesthesia, Headache, Analgesia
What is being tested?
Infiltration of 2% Lidocaine with Needle and Infiltration of 2% Lidocaine without Needle
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteIndonesia
Study dates
1 Nov 2021to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site
  • RSUPN Cipto Mangunkusumo

    Jakarta, 01430

Other trials in Indonesia

About this study

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.

Read the 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

Being tested
Infiltration of 2% Lidocaine with Needle, Infiltration of 2% Lidocaine without Needle
Keywords
Lidocaine infiltration, Epidural needle insertion, Epidural anesthesia.
Medical subject headings
Headache, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infiltration of 2% Lidocaine with NeedleDevice

    Infiltration of 2% Lidocaine with Needle

  • Infiltration of 2% Lidocaine without NeedleDevice

    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

Study groups in NCT05326867
Study groupRoleWhat they receive
Infiltration of 2% Lidocaine with NeedleActive comparatorFree 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
Receives: Device: Infiltration of 2% Lidocaine with Needle
Infiltration of 2% Lidocaine without NeedleActive comparatorFree 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
Receives: Device: Infiltration of 2% Lidocaine without Needle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Scale (NPRS scale) when Lidocaine Infiltrated

    The pain measurement with NPRS scale when 2% Lidocaine infiltrated

    Measured: Immediately after Lidocaine is infiltrated

  2. Pain Scale (NPRS scale) when Epidural Needle Inserted

    The pain measurement with NPRS scale when Epidural Needle Inserted

    Measured: Immediately after Epidural Needle Inserted

  3. Patient's Movement when Lidocaine Infiltrated

    Observation of patient's movement when 2% Lidocaine infiltrated

    Measured: Immediately after Lidocaine is infiltrated

  4. Patient's Movement when Epidural Needle Inserted

    Observation of patient's movement when Epidural Needle Inserted

    Measured: Immediately after Epidural Needle Inserted

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2022
  2. Study start1 Nov 2021
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05326867
Sponsor's protocol ID
IF
Status last verified
Apr 2022
First submitted
28 Mar 2022
Last updated
27 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Infiltration of 2% Lidocaine with Needle and Infiltration of 2% Lidocaine without Needle in people with Epidural; Anesthesia, Headache and Analgesia, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Scale (NPRS scale) when Lidocaine Infiltrated (time frame: Immediately after Lidocaine is infiltrated). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.

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