Phase 4
N=40
Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT04495868 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Needle Placement Pain Score — 0; 0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bacteriostatic Normal Saline (Drug); 1% Lidocaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Needle Placement Pain Score |
0; 0 | — |
| SECONDARY Skin Wheal Pain Score |
5; 6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients scheduled for an initial lumbar medial branch block
Exclusion Criteria
- Allergy to local anesthetics
- Fibromyalgia
- Inability to provide informed consent in English
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Data sourced from ClinicalTrials.gov (NCT04495868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.