Needle Insertion and Injection PainNCT03206320
Topical Lidocaine for Needle Insertion and Injection Pain
A study testing Lidocaine Topical in people with Needle Insertion and Injection Pain, run by New York School of Regional Anesthesia at 1 site in Belgium.
Trial summary
Skin infiltration with local anesthetic is commonly used to decrease patient discomfort during peripheral nerve blocks. Topically applied local anesthetic gel might provide analgesia while eliminating the need for additional injections. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Needle Insertion and Injection Pain
- What is being tested?
- Lidocaine Topical
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Dec 2016to 31 Oct 2019
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand Dutch, French or English language, purpose and risks of the study, provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations
- Age >18 at the time of informed consent
- ASA I-III physical class
- Scheduled for elective shoulder or upper arm surgery requiring a preoperative interscalene brachial (ISBP) or axillary (AX) plexus block
Who cannot join
- History of an allergy or contra-indication to a local anesthetic
- Baseline neurological deficit
- Medical condition that will make it difficult to assess sensory distribution or communicate with a staff member
- Presence of preexisting coagulation disorders
- Infection at injection site
- Concomitant opioid therapy
- Recent history (<3 months) of drug or alcohol abuse
- Female subjects who are pregnant or currently breastfeeding, or who have a positive pregnancy test result at first visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Lidocaine 2% Gel for Analgesia and Patient Comfort During Interscalene Brachial Plexus and Axillary Blocks: A Noninferiority Randomized Trial
Skin infiltration with local anesthetic is commonly used to decrease patient discomfort during peripheral nerve blocks. Topically applied local anesthetic gel might provide analgesia while eliminating the need for additional injections. The primary objective of this study was a noninferiority comparison between the analgesia achieved with topical gel with that of skin infiltration for pain upon needle insertion and injection during administration of the interscalene brachial (ISBP) and axillary (AX) plexus blocks.
- Conditions
- Needle Insertion and Injection Pain
- Being tested
- Lidocaine Topical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine TopicalDrug
Comparison of lidocaine topical gel with lidocaine infiltration and with no local anesthesia in reducing needle insertion and injection pain
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Reference | Active comparator | Not described Receives: Drug: Lidocaine Topical |
| New | Experimental | Not described Receives: Drug: Lidocaine Topical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needle insertion pain
Pain rating (VAS)
Measured: Immediately at the time the needle is inserted through the skin
Injection pain
Pain rating (VAS)
Measured: Immediately at the end of the block
Secondary outcomes (2)
Fearfulness
Likert scale from "1" (no fear) to "5" (very fearful)
Measured: Just before the nerve block
Overall discomfort
Verbal rating scale from "0" (more comfortable/less painful than expected) to "10" (less comfortable/more painful than expected)
Measured: Immediately at the end of the block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start5 Dec 2016
- Primary completion31 Jul 2017
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Needle Insertion and Injection PainStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York School of Regional Anesthesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Vandepitte, M.D., Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206320
- Sponsor's protocol ID
- SMBe1701
- Status last verified
- May 2025
- First submitted
- 22 Jun 2017
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Lidocaine 2% Gel for Analgesia and Patient Comfort During Interscalene Brachial Plexus and Axillary Blocks: A Noninferiority Randomized Trial
- ClinicalTrials.gov ID
- NCT03206320
- Acronym / sponsor ID
- SMBe1701
- Conditions
- Needle Insertion and Injection Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- New York School of Regional AnesthesiaUniversity, hospital or other
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 2 Jul 2017 (actual)
- 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.
Skin infiltration with local anesthetic is commonly used to decrease patient discomfort during peripheral nerve blocks. Topically applied local anesthetic gel might provide analgesia while eliminating the need for additional injections. The primary objective of this study was a noninferiority comparison between the analgesia achieved with topical gel with that of skin infiltration for pain upon needle insertion and injection during administration of the interscalene brachial (ISBP) and axillary (AX) plexus blocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Reference | Active comparator | Drug: Lidocaine Topical |
| New | Experimental | Drug: Lidocaine Topical |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to understand Dutch, French or English language, purpose and risks of the study, provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations
- Age >18 at the time of informed consent
- ASA I-III physical class
- Scheduled for elective shoulder or upper arm surgery requiring a preoperative interscalene brachial (ISBP) or axillary (AX) plexus block
Key exclusion criteria (8 listed)
- History of an allergy or contra-indication to a local anesthetic
- Baseline neurological deficit
- Medical condition that will make it difficult to assess sensory distribution or communicate with a staff member
- Presence of preexisting coagulation disorders
- Infection at injection site
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 |
|---|---|---|
| Lidocaine TopicalComparison of lidocaine topical gel with lidocaine infiltration and with no local anesthesia in reducing needle insertion and injection pain | Drug | New, Reference |
Primary outcome
Needle insertion pain
Time frame: Immediately at the time the needle is inserted through the skin
Pain rating (VAS)
Injection pain
Time frame: Immediately at the end of the block
Pain rating (VAS)
2 secondary outcomes
Fearfulness
Time frame: Just before the nerve block
Overall discomfort
Time frame: Immediately at the end of the block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine Topical in people with Needle Insertion and Injection Pain, run by New York School of Regional Anesthesia at 1 site in Belgium.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 23 May 2025. 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 Belgium. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Needle insertion pain (time frame: Immediately at the time the needle is inserted through the skin). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2025.