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

NCT05326867 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2022-04-27

No results posted yet for this study

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

Interventions

DEVICE

Infiltration of 2% Lidocaine with Needle

Infiltration of 2% Lidocaine with Needle

DEVICE

Infiltration of 2% Lidocaine without 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

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Raden B Sukmono · Indonesia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05326867 on ClinicalTrials.gov