NCT04495868 is a Phase 4 clinical trial of Bacteriostatic Normal Saline in Chronic Pain, sponsored by Emory University.

Who is sponsoring NCT04495868?

NCT04495868 is sponsored by Emory University.

What drugs are being tested in NCT04495868?

Interventions in NCT04495868: Bacteriostatic Normal Saline, 1% Lidocaine.

What condition does NCT04495868 study?

NCT04495868 studies Chronic Pain.

Is NCT04495868 still recruiting?

NCT04495868 is currently completed. Last updated 18 April 2023.

Are results published for NCT04495868?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-04-18 · How we verify

NCT04495868

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

Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia

Completed Phase 4 Results posted Last updated 18 April 2023

What this trial tests

Phase 4 trial testing Bacteriostatic Normal Saline in Chronic Pain in 40 participants. Completed in 6 April 2022.

Timeline

8 January 2021

Primary endpoint
6 April 2022

6 April 2022

Quick facts

Lead sponsor	Emory University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	supportive care
Enrollment	40
Start date	8 January 2021
Primary completion	6 April 2022
Estimated completion	6 April 2022
Sites	1 location across United States

Drugs / interventions tested

Bacteriostatic Normal Saline — full drug profile →
1% Lidocaine — full drug profile →

Conditions studied

Chronic Pain — all drugs for Chronic Pain →

Sponsor

Emory University

Who can join

18 and older, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Needle Placement Pain Score Primary · Day 1

Participants rated their pain level from the insertion of the needle for the lumbar medial branch block using the skin wheal created with each anesthetic. Pain is rated on a scale from 0 to 10, where 0 = no pain and 10 = worst pain.

Group	Value	95% CI
Bacteriostatic Normal Saline	0	0 – 1
1% Lidocaine	0	0 – 0

Skin Wheal Pain Score Secondary · Day 1

Participants rated their pain level from the creation of the skin wheal using each anesthetic on a scale from 0 to 10, where 0 = no pain and 10 = worst pain.

Group	Value	95% CI
Bacteriostatic Normal Saline	5	2 – 7
1% Lidocaine	6	4 – 9

Sponsor's own description

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.

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 Chronic Pain

Currently open trials in the same condition.

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NCT07103135 — Optimizing Accelerated TMS for Chronic Pain With Thompson Sampling · Phase 1 · recruiting
NCT06219408 — CIH Stepped Care for Co-occurring Chronic Pain and PTSD · NA · recruiting
NCT07270406 — Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain · NA · recruiting

Other Emory University trials

Trials by the same sponsor.

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NCT07189819 — Innovative Closed-loop Functional Electrical Stimulation Control System for Augmenting Post-stroke Gait · NA · not yet recruiting
NCT06451055 — Low-calorie Diet in Isolated Impaired Fasting Glucose · NA · not yet recruiting
NCT07405476 — Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative I · Phase 2 · recruiting
NCT06708351 — Enhancing Cervical Cancer Screening and Treatment in Women Living With HIV in Kenya, the ENHANCE LINKAge Trial · NA · not yet 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 NCT04495868 (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 Emory University
Last refreshed: 18 April 2023

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/NCT04495868.

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