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

Primary Purpose

Epidural; Anesthesia, Headache, Analgesia

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Infiltration of 2% Lidocaine with Needle
Infiltration of 2% Lidocaine without Needle
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epidural; Anesthesia, Headache focused on measuring Lidocaine infiltration, Epidural needle insertion, Epidural anesthesia.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • RSUPN Cipto Mangunkusumo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Infiltration of 2% Lidocaine with Needle

Infiltration of 2% Lidocaine without Needle

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain Scale (NPRS scale) when Lidocaine Infiltrated
The pain measurement with NPRS scale when 2% Lidocaine infiltrated
Pain Scale (NPRS scale) when Epidural Needle Inserted
The pain measurement with NPRS scale when Epidural Needle Inserted
Patient's Movement when Lidocaine Infiltrated
Observation of patient's movement when 2% Lidocaine infiltrated
Patient's Movement when Epidural Needle Inserted
Observation of patient's movement when Epidural Needle Inserted

Secondary Outcome Measures

Full Information

First Posted
March 28, 2022
Last Updated
April 20, 2022
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT05326867
Brief Title
Comparison of Infiltration of 2% Lidocaine With and Without Needle as Analgesia in Epidural Needle Insertion
Official Title
Comparison of Infiltration of 2% Lidocaine With and Without Needle as Analgesia in Epidural Needle Insertion
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidural; Anesthesia, Headache, Analgesia
Keywords
Lidocaine infiltration, Epidural needle insertion, Epidural anesthesia.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Masking Description
Participants, care providers, and investigators are blinded
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infiltration of 2% Lidocaine with Needle
Arm Type
Active Comparator
Arm Description
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
Arm Title
Infiltration of 2% Lidocaine without Needle
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Infiltration of 2% Lidocaine with Needle
Intervention Description
Infiltration of 2% Lidocaine with Needle
Intervention Type
Device
Intervention Name(s)
Infiltration of 2% Lidocaine without Needle
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain Scale (NPRS scale) when Lidocaine Infiltrated
Description
The pain measurement with NPRS scale when 2% Lidocaine infiltrated
Time Frame
Immediately after Lidocaine is infiltrated
Title
Pain Scale (NPRS scale) when Epidural Needle Inserted
Description
The pain measurement with NPRS scale when Epidural Needle Inserted
Time Frame
Immediately after Epidural Needle Inserted
Title
Patient's Movement when Lidocaine Infiltrated
Description
Observation of patient's movement when 2% Lidocaine infiltrated
Time Frame
Immediately after Lidocaine is infiltrated
Title
Patient's Movement when Epidural Needle Inserted
Description
Observation of patient's movement when Epidural Needle Inserted
Time Frame
Immediately after Epidural Needle Inserted

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raden B Sukmono
Organizational Affiliation
Indonesia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
RSUPN Cipto Mangunkusumo
City
Jakarta
ZIP/Postal Code
01430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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