Local AnesthesiaPhase 4NCT02647892
Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia
A Phase 4 study testing lidocaine and sodium bicarbonate in people with Local Anesthesia, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this study is to determine the optimal amount of lidocaine buffering needed to decrease injection pain when administering local anesthesia. Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Local Anesthesia
- What is being tested?
- lidocaine and sodium bicarbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2016to 5 Nov 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults presenting for routine thyroid biopsy, paracentesis or thoracentesis in interventional radiology
Who cannot join
- Patients requiring sedation
- Patients with altered mental status
- Children
- Patients allergic to lidocaine or sodium bicarbonate
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
The purpose of this study is to determine the optimal amount of lidocaine buffering needed to decrease injection pain when administering local anesthesia.
Read the 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.
- Conditions
- Local Anesthesia
- Being tested
- lidocaine, sodium bicarbonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaineDrug
Also called xylocaine
local anesthesia
sodium bicarbonateDrug
additional drug added to lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | 10 mg/mL lidocaine; Frequency: 1 Receives: Drug: lidocaine |
| Arm B | Active comparator | 9 mg/mL of 10% sodium bicarbonate-90% lidocaine; Frequency: 1 Receives: Drug: lidocaine; Drug: sodium bicarbonate |
| Arm C | Active comparator | 7.5 mg/Ml of 25% sodium bicarbonate-75% lidocaine Frequency: 1 Receives: Drug: lidocaine; Drug: sodium bicarbonate |
| Arm D | Active comparator | 5 mg/mL 50% sodium bicarbonate-50% lidocaine Frequency: 1 Receives: Drug: lidocaine; Drug: sodium bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injection pain
numeric pain scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study start8 Jan 2016
- Primary completion5 Nov 2021
- Study completion5 Nov 2021
Why it stopped: IRB protocol administratively closed, Continuing Review or Study Completion Report not submitted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Local AnesthesiaStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph McBride, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02647892
- Sponsor's protocol ID
- 0787-15-EP
- Status last verified
- Aug 2023
- First submitted
- 17 Dec 2015
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 25991379Bartfield 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.
PubMed 2240750Colaric 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.
PubMed 9672449Orlinsky 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.
PubMed 1430977Matsumoto 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.
PubMed 8136599Machin D, Campbell M, Fayers P, Pinol A. 1997. Sample Size Tables for Clinical Studies, 2nd Edition. Blackwell Science. Malden MA.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia
- ClinicalTrials.gov ID
- NCT02647892
- Acronym / sponsor ID
- 0787-15-EP
- Conditions
- Local Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB protocol administratively closed, Continuing Review or Study Completion Report not submitted
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 8 Jan 2016 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the optimal amount of lidocaine buffering needed to decrease injection pain when administering local anesthesia.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: lidocaine10 mg/mL lidocaine; Frequency: 1 |
| Arm B | Active comparator | Drug: lidocaine, Drug: sodium bicarbonate9 mg/mL of 10% sodium bicarbonate-90% lidocaine; Frequency: 1 |
| Arm C | Active comparator | Drug: lidocaine, Drug: sodium bicarbonate7.5 mg/Ml of 25% sodium bicarbonate-75% lidocaine Frequency: 1 |
| Arm D | Active comparator | Drug: lidocaine, Drug: sodium bicarbonate5 mg/mL 50% sodium bicarbonate-50% lidocaine Frequency: 1 |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults presenting for routine thyroid biopsy, paracentesis or thoracentesis in interventional radiology
Key exclusion criteria (4 listed)
- Patients requiring sedation
- Patients with altered mental status
- Children
- Patients allergic to lidocaine or sodium bicarbonate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lidocaineAlso: xylocainelocal anesthesia | Drug | Arm A, Arm B, Arm C, Arm D |
| sodium bicarbonateadditional drug added to lidocaine | Drug | Arm B, Arm C, Arm D |
Primary outcome
Injection pain
Time frame: 6 months
numeric pain scale
Results and safety
The study was stopped early (reason given: IRB protocol administratively closed, Continuing Review or Study Completion Report not submitted). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Background: PubMed 25991379Skarsvag 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.
- Background: PubMed 2240750Bartfield 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.
- Background: PubMed 9672449Colaric 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.
- Background: PubMed 1430977Orlinsky 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.
- Background: PubMed 8136599Matsumoto 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.
- BackgroundMachin D, Campbell M, Fayers P, Pinol A. 1997. Sample Size Tables for Clinical Studies, 2nd Edition. Blackwell Science. Malden MA.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph McBride, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lidocaine and sodium bicarbonate in people with Local Anesthesia, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: IRB protocol administratively closed, Continuing Review or Study Completion Report not submitted). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injection pain (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02647892, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.