Who is sponsoring NCT05326867?

NCT05326867 is sponsored by Indonesia University.

What drugs are being tested in NCT05326867?

Interventions in NCT05326867: Infiltration of 2% Lidocaine with Needle, Infiltration of 2% Lidocaine without Needle.

What condition does NCT05326867 study?

NCT05326867 studies Epidural; Anesthesia, Headache, Analgesia.

Is NCT05326867 still recruiting?

NCT05326867 is currently completed. Last updated 27 April 2022.

Last reviewed 2022-04-27 · How we verify

NCT05326867

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 27 April 2022

What this trial tests

NA trial testing Infiltration of 2% Lidocaine with Needle in Epidural; Anesthesia, Headache in 84 participants. Completed in 31 December 2021.

Timeline

1 November 2021

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	Indonesia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	84
Start date	1 November 2021
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	1 location across Indonesia

Drugs / interventions tested

Infiltration of 2% Lidocaine with Needle
Infiltration of 2% Lidocaine without Needle

Conditions studied

Epidural; Anesthesia, Headache — all drugs for Epidural; Anesthesia, Headache →
Analgesia — all drugs for Analgesia →

Sponsor

Indonesia University

Who can join

Adults 18 to 65, any sex, with Epidural; Anesthesia, Headache or Analgesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Epidural; Anesthesia, Headache

Currently open trials in the same condition.

NCT06471790 — Inertial Sensors for Obstetrical Walking Epidural Tracking · recruiting
NCT04095117 — Evaluation of Sagittal Abdominal Diameter as a Predictor of the Skin to Epidural Space Distance in Obese Patients · recruiting

Other Indonesia University trials

Trials by the same sponsor.

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NCT07337187 — Effect of Thread-Embedding Acupuncture at EX-B2 on Pain and Quality of Life in Chronic Low Back Pain · NA · not yet recruiting
NCT07242001 — Laser Acupuncture for Otitis Media With Effusion in Children · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05326867 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Indonesia University
Last refreshed: 27 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05326867.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing