- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02647892
Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia
August 16, 2023 updated by: University of Nebraska
The purpose of this study is to determine the optimal amount of lidocaine buffering needed to decrease injection pain when administering local anesthesia.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Once the site is chosen, the skin will be anesthetized as usual.
This study will utilize a commercially prepared 1% lidocaine solution mixed with standard sodium bicarbonate.
A total of 10 mL will be used.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nebraska
-
Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 98 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- adults presenting for routine thyroid biopsy, paracentesis or thoracentesis in interventional radiology
Exclusion Criteria:
- Patients requiring sedation
- Patients with altered mental status
- Children
- Patients allergic to lidocaine or sodium bicarbonate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm A
10 mg/mL lidocaine; Frequency: 1
|
local anesthesia
Other Names:
|
Active Comparator: Arm B
9 mg/mL of 10% sodium bicarbonate-90% lidocaine; Frequency: 1
|
local anesthesia
Other Names:
additional drug added to lidocaine
|
Active Comparator: Arm C
7.5 mg/Ml of 25% sodium bicarbonate-75% lidocaine Frequency: 1
|
local anesthesia
Other Names:
additional drug added to lidocaine
|
Active Comparator: Arm D
5 mg/mL 50% sodium bicarbonate-50% lidocaine Frequency: 1
|
local anesthesia
Other Names:
additional drug added to lidocaine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Injection pain
Time Frame: 6 months
|
numeric pain scale
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joseph McBride, MD, University of Nebraska
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Skarsvag TI, Wago KJ, Tangen LF, Lundbom JS, Hjelseng T, Ballo S, Finsen V. Does adjusting the pH of lidocaine reduce pain during injection? J Plast Surg Hand Surg. 2015 Oct;49(5):265-267. doi: 10.3109/2000656X.2015.1047780. Epub 2015 May 19.
- Bartfield JM, Gennis P, Barbera J, Breuer B, Gallagher EJ. Buffered versus plain lidocaine as a local anesthetic for simple laceration repair. Ann Emerg Med. 1990 Dec;19(12):1387-9. doi: 10.1016/s0196-0644(05)82603-4.
- Colaric KB, Overton DT, Moore K. Pain reduction in lidocaine administration through buffering and warming. Am J Emerg Med. 1998 Jul;16(4):353-6. doi: 10.1016/s0735-6757(98)90126-7.
- Orlinsky M, Hudson C, Chan L, Deslauriers R. Pain comparison of unbuffered versus buffered lidocaine in local wound infiltration. J Emerg Med. 1992 Jul-Aug;10(4):411-5. doi: 10.1016/0736-4679(92)90269-y.
- Matsumoto AH, Reifsnyder AC, Hartwell GD, Angle JF, Selby JB Jr, Tegtmeyer CJ. Reducing the discomfort of lidocaine administration through pH buffering. J Vasc Interv Radiol. 1994 Jan-Feb;5(1):171-5. doi: 10.1016/s1051-0443(94)71478-0.
- Machin D, Campbell M, Fayers P, Pinol A. 1997. Sample Size Tables for Clinical Studies, 2nd Edition. Blackwell Science. Malden MA.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 8, 2016
Primary Completion (Actual)
November 5, 2021
Study Completion (Actual)
November 5, 2021
Study Registration Dates
First Submitted
December 17, 2015
First Submitted That Met QC Criteria
January 5, 2016
First Posted (Estimated)
January 6, 2016
Study Record Updates
Last Update Posted (Actual)
August 21, 2023
Last Update Submitted That Met QC Criteria
August 16, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- 0787-15-EP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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