CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Bacteriostatic Normal Saline +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04495868
NCT04495868Phase 4Completed
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Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia During Lumbar Medial Branch Block

Emory University·interventional·Posted Aug 3, 2020·Updated Apr 18, 2023

In Brief

A Phase 4 clinical trial evaluating Bacteriostatic Normal Saline and 1% Lidocaine for Chronic Pain. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if creation of a skin wheel with bacteriostatic normal saline, which includes 0.9% benzyl alcohol, is less painful and provides a similar level of anesthesia compared to 1% lidocaine. Participants will receive both types of anesthesia, in random order.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Pain
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedAug 3, 2020
Enrollment StartJan 8, 2021
Primary CompletionApr 6, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 5.9 years ago

Interventions

Bacteriostatic Normal Salinedrug

A skin wheal will be made with bacteriostatic normal saline (BNS). BNS contains 0.9% benzyl alcohol and benzyl alcohol is an opium alkaloid that is sometimes added to physiologic normal saline for its bacteriostatic properties. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.

1% Lidocainedrug

A skin wheal will be made with 1% lidocaine. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.