Neuropathic PainNCT02300038
Lidocaine and Neuroma Pain Related Modalities
A study testing Lidocaine (Xylocaine) and NaCl in people with Neuropathic Pain, run by Uppsala University.
Trial summary
Background Subanesthetics concentrations of lidocaine are able to produce a differential block of the ectopic discharges, but not propagation of impulses, suppressing differentially the associated neuropathic pain symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Lidocaine (Xylocaine) and NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Sep 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older,
- with a history of persistent spontaneous and/or evoked pain (by e.g. touch, movement),
- who scored an average daily pain intensity of at least 4 on a 0-10 point numerical pain scale (NRS) interfering with daily activities and who had pain at least 3 months duration.
- They all had neuromas after upper extremity surgery or other trauma affecting the radial, ulnar, median or digital nerves and were eligible to participate in the study after giving written informed consent.
Who cannot join
- Patients with other conditions that might confound assessment of pain attributed to posttraumatic upper limb pain or
- any condition/disease that could interfere with the study measurements, such as drug abuse, diabetes, vascular disease, polyneuropathy or psychiatric diseases were excluded.
About this study
Official title: Differential Analgesic Effects of Subanesthetic Concentrations of Lidocaine on Spontaneous and Evoked Pain in Human Painful Neuroma
Background Subanesthetics concentrations of lidocaine are able to produce a differential block of the ectopic discharges, but not propagation of impulses, suppressing differentially the associated neuropathic pain symptoms. The aim of this study was to investigate the differences between the analgesic effects of lidocaine 0.5% and a control group of lidocaine 0.1% on several neuroma related pain modalities.
Methods Sixteen patients with neuropathic pain due to painful neuromas caused by nerve injury participated in this randomized, double-blind experiment. The patterns of sensory changes were compared before and after injection of 1 ml lidocaine 0.5% and 0.1% close to the neuroma, the sessions being 1-2 weeks apart. Spontaneous and evoked pains were assessed using a visual analogue scale (VAS), quantitative and qualitative sensory testing.
Read the detailed description
Patients were recruited by using a postal follow up questionnaire . The number of enrolled subjects in this study- 16 patients, Study design
- The patients visited the Pain Clinic twice.
- The same investigator (AM) performed all study procedure assessments.
- Neuroma was localized by Tinel's sign 14 and when possible (7 patients out of 16), the localization of a neuroma was verified by ultrasound.
Administration of study drug The patients were randomized by a computer generated random list to receive either 1ml lidocaine 0.5% (A) or 1 ml 0.1% (B-control) injected perineuromally.
Pain assessments Duration of the present pain condition was recorded. The patients were asked to rate the mean, maximum, minimum pain intensity of their spontaneous and evoked pain in the week prior to both visits. The pain score was measured from baseline until 60 min after injection. Assessments of pain were done post injection at 15 s, 30 s, 1 min, and at 5-min intervals for the first 30-min post injection and then every 10-min to 1 hr post injection. The assessments of pain were performed between the limbs in the following order: spontaneous pain, then assessment of dynamic mechanical allodynia and then pinprick hyperalgesia.
Spontaneous pain Evaluation of sensory function was performed in the affected limb using bedside examination according to EFNS (European Federation of Neurological Societies)guidelines: light touch, pinprick sense, warmth (40°) and cold (25°) temperature stimuli were tested.
- Conditions
- Neuropathic Pain
- Being tested
- Lidocaine (Xylocaine), NaCl
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine (Xylocaine)Drug
Also called Xylocaine, Lidocaine
perineuromally administration of 1 ml lidocaine
NaClDietary supplement
Also called Sodium chloride, salt
perineuromally administration of NaCL
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine (Xylocaine) 0.5% | Active comparator | Injection of 1ml after mixing Lidocaine 10 mg/ml 1 ml +1 ml NaCl was administrated perineuromally Receives: Drug: Lidocaine (Xylocaine); Dietary Supplement: NaCl |
| Lidocaine (Xylocaine) 10 mg/ml 0.01% | Placebo comparator | Injection of 1 ml from 10 mg/ml 1 ml lidocaine Xylocaine +10 ml Nacl was adminsitrated perineuromally Receives: Drug: Lidocaine (Xylocaine); Dietary Supplement: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end-point measure was defined as the change in pain score measured from baseline until 60 min after injection
Measured: 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startApr 2010
- Primary completionAug 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriana Miclescu, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300038
- Sponsor's protocol ID
- UppsalaU
- Status last verified
- Nov 2014
- First submitted
- 16 Nov 2014
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Analgesic Effects of Subanesthetic Concentrations of Lidocaine on Spontaneous and Evoked Pain in Human Painful Neuroma
- ClinicalTrials.gov ID
- NCT02300038
- Acronym / sponsor ID
- UppsalaU
- Conditions
- Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 24 Nov 2014 (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.
Background Subanesthetics concentrations of lidocaine are able to produce a differential block of the ectopic discharges, but not propagation of impulses, suppressing differentially the associated neuropathic pain symptoms. The aim of this study was to investigate the differences between the analgesic effects of lidocaine 0.5% and a control group of lidocaine 0.1% on several neuroma related pain modalities.
Methods Sixteen patients with neuropathic pain due to painful neuromas caused by nerve injury participated in this randomized, double-blind experiment. The patterns of sensory changes were compared before and after injection of 1 ml lidocaine 0.5% and 0.1% close to the neuroma, the sessions being 1-2 weeks apart. Spontaneous and evoked pains were assessed using a visual analogue scale (VAS), quantitative and qualitative sensory testing.
Detailed description
Patients were recruited by using a postal follow up questionnaire . The number of enrolled subjects in this study- 16 patients, Study design
- The patients visited the Pain Clinic twice.
- The same investigator (AM) performed all study procedure assessments.
- Neuroma was localized by Tinel's sign 14 and when possible (7 patients out of 16), the localization of a neuroma was verified by ultrasound.
Administration of study drug The patients were randomized by a computer generated random list to receive either 1ml lidocaine 0.5% (A) or 1 ml 0.1% (B-control) injected perineuromally.
Pain assessments Duration of the present pain condition was recorded. The patients were asked to rate the mean, maximum, minimum pain intensity of their spontaneous and evoked pain in the week prior to both visits. The pain score was measured from baseline until 60 min after injection. Assessments of pain were done post injection at 15 s, 30 s, 1 min, and at 5-min intervals for the first 30-min post injection and then every 10-min to 1 hr post injection. The assessments of pain were performed between the limbs in the following order: spontaneous pain, then assessment of dynamic mechanical allodynia and then pinprick hyperalgesia.
Spontaneous pain Evaluation of sensory function was performed in the affected limb using bedside examination according to EFNS (European Federation of Neurological Societies)guidelines: light touch, pinprick sense, warmth (40°) and cold (25°) temperature stimuli were tested.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine (Xylocaine) 0.5% | Active comparator | Drug: Lidocaine (Xylocaine), Dietary Supplement: NaClInjection of 1ml after mixing Lidocaine 10 mg/ml 1 ml +1 ml NaCl was administrated perineuromally |
| Lidocaine (Xylocaine) 10 mg/ml 0.01% | Placebo comparator | Drug: Lidocaine (Xylocaine), Dietary Supplement: NaClInjection of 1 ml from 10 mg/ml 1 ml lidocaine Xylocaine +10 ml Nacl was adminsitrated perineuromally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older,
- with a history of persistent spontaneous and/or evoked pain (by e.g. touch, movement),
- who scored an average daily pain intensity of at least 4 on a 0-10 point numerical pain scale (NRS) interfering with daily activities and who had pain at least 3 months duration.
- They all had neuromas after upper extremity surgery or other trauma affecting the radial, ulnar, median or digital nerves and were eligible to participate in the study after giving written informed consent.
Key exclusion criteria (2 listed)
- Patients with other conditions that might confound assessment of pain attributed to posttraumatic upper limb pain or
- any condition/disease that could interfere with the study measurements, such as drug abuse, diabetes, vascular disease, polyneuropathy or psychiatric diseases were excluded.
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 (Xylocaine)Also: Xylocaine, Lidocaineperineuromally administration of 1 ml lidocaine | Drug | Lidocaine (Xylocaine) 0.5%, Lidocaine (Xylocaine) 10 mg/ml 0.01% |
| NaClAlso: Sodium chloride, saltperineuromally administration of NaCL | Dietary supplement | Lidocaine (Xylocaine) 0.5%, Lidocaine (Xylocaine) 10 mg/ml 0.01% |
Primary outcome
The primary end-point measure was defined as the change in pain score measured from baseline until 60 min after injection
Time frame: 60 min
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 24 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine (Xylocaine) and NaCl in people with Neuropathic Pain, run by Uppsala University.
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 2 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 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The primary end-point measure was defined as the change in pain score measured from baseline until 60 min after injection (time frame: 60 min). 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 24 Nov 2014.