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

NCT05326867 | Completed

• 1 other identifier: IF
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Epidural; Anesthesia, Headache; Analgesia

Keywords

Lidocaine infiltration; Epidural needle insertion; Epidural anesthesia.

Outcome Measures

Primary Outcomes (4)

• Pain Scale (NPRS scale) when Lidocaine Infiltrated

  The pain measurement with NPRS scale when 2% Lidocaine infiltrated

  Immediately after Lidocaine is infiltrated

• Pain Scale (NPRS scale) when Epidural Needle Inserted

  The pain measurement with NPRS scale when Epidural Needle Inserted

  Immediately after Epidural Needle Inserted

• Patient's Movement when Lidocaine Infiltrated

  Observation of patient's movement when 2% Lidocaine infiltrated

  Immediately after Lidocaine is infiltrated

• Patient's Movement when Epidural Needle Inserted

  Observation of patient's movement when Epidural Needle Inserted

  Immediately after Epidural Needle Inserted

Study Arms (2)

Infiltration of 2% Lidocaine with Needle

ACTIVE COMPARATOR

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

Device: Infiltration of 2% Lidocaine with Needle

Infiltration of 2% Lidocaine without Needle

ACTIVE COMPARATOR

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

Device: Infiltration of 2% Lidocaine without Needle

Interventions

Infiltration of 2% Lidocaine with Needle DEVICE

Infiltration of 2% Lidocaine with Needle

Infiltration of 2% Lidocaine with Needle

Infiltration of 2% Lidocaine without Needle DEVICE

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

Infiltration of 2% Lidocaine without Needle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

RSUPN Cipto Mangunkusumo

Jakarta, 01430, Indonesia

Location

MeSH Terms

Conditions

Headache; Agnosia

Interventions

Needles

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Raden B Sukmono

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants, care providers, and investigators are blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Model Details: 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

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 14, 2022
• Study Start: November 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)