Neuropathic PainNCT03317600
Postamputation Pain: Peripheral Mechanisms
A study testing Lidocaine in people with Neuropathic Pain and Amputation, Traumatic, run by Danish Pain Research Center at 1 site in Denmark.
Trial summary
Stump and phantom pain after amputation are common, but the responsible mechanisms are still not clarified. It has been suggested that phantom limb pain can be reduced by regional anaesthesia and in several recent studies, pain was reduced following intrathecal and intraforaminal blocks. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neuropathic Pain, Amputation, Traumatic, Nerve Block
- What is being tested?
- Lidocaine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Oct 2017to 28 Feb 2018
- 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
- Amputees with chronic amputation pain (stump or phantom pain) 3 or above on NRS (numerical ratio scale).
Who cannot join
- Severe somatic or psychiatric diseases
- Other peripheral neuropathy
- Lack of ability to cooperate to the clinical examination
- Allergy to Lidocaine or similar analgetics
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Pain Research Center, Aarhus University Hospital
Aarhus, 8000
About this study
Stump and phantom pain after amputation are common, but the responsible mechanisms are still not clarified. It has been suggested that phantom limb pain can be reduced by regional anaesthesia and in several recent studies, pain was reduced following intrathecal and intraforaminal blocks. In this study, the investigators want to investigate if spontaneous and evoked pain in amputees will be relieved by regional nerve blocks involving the damaged nerves.
- Being tested
- Lidocaine, Placebo
- Medical subject headings
- Neuralgia, Amputation, Traumatic, Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDevice
Intervention is a nerve block with Lidocaine 2% with Adrenaline.
PlaceboDrug
Intervention is a "placebo" nerve block with isotonic saline
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine block | Active comparator | Not described Receives: Device: Lidocaine |
| Isotonic saline block | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in spontaneous pain on a Numeric Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain)
The patient will be asked about spontaneous pain, including stump and phantom pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst pain).
Measured: From 0 minutes until 120 minutes after injection
Secondary outcomes (1)
Reduction in evoked pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain).
The patient will be asked about evoked pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst pain). Evoked pain is triggered by a SOMEDIC brush, thermo rolls (20 degrees Celcius and 40 degrees Celcius) and pinprick with a von Frey filament (60 g).
Measured: From 0 minutes until 120 minutes after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start25 Oct 2017
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
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.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Pain Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317600
- Sponsor's protocol ID
- Nerveblock2017
- Status last verified
- Jul 2018
- First submitted
- 13 Oct 2017
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postamputation Pain: Peripheral Mechanisms
- ClinicalTrials.gov ID
- NCT03317600
- Acronym / sponsor ID
- Nerveblock2017
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Danish Pain Research CenterUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 23 Oct 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.
Stump and phantom pain after amputation are common, but the responsible mechanisms are still not clarified. It has been suggested that phantom limb pain can be reduced by regional anaesthesia and in several recent studies, pain was reduced following intrathecal and intraforaminal blocks. In this study, the investigators want to investigate if spontaneous and evoked pain in amputees will be relieved by regional nerve blocks involving the damaged nerves.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine block | Active comparator | Device: Lidocaine |
| Isotonic saline block | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Amputees with chronic amputation pain (stump or phantom pain) 3 or above on NRS (numerical ratio scale).
Key exclusion criteria (4 listed)
- Severe somatic or psychiatric diseases
- Other peripheral neuropathy
- Lack of ability to cooperate to the clinical examination
- Allergy to Lidocaine or similar analgetics
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 |
|---|---|---|
| LidocaineIntervention is a nerve block with Lidocaine 2% with Adrenaline. | Device | Lidocaine block |
| PlaceboIntervention is a "placebo" nerve block with isotonic saline | Drug | Isotonic saline block |
Primary outcome
Reduction in spontaneous pain on a Numeric Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain)
Time frame: From 0 minutes until 120 minutes after injection
The patient will be asked about spontaneous pain, including stump and phantom pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst pain).
1 secondary outcome
Reduction in evoked pain on a Numerical Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain).
Time frame: From 0 minutes until 120 minutes after injection
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 16 Jul 2018.
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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.
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 in people with Neuropathic Pain and Amputation, Traumatic, run by Danish Pain Research Center at 1 site in Denmark.
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: finished, as of the sponsor's last update on 16 Jul 2018. 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 Denmark. 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. 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?
Reduction in spontaneous pain on a Numeric Rating Scale (NRS: 0-10, 0 = no pain, 10 = worst possible pain) (time frame: From 0 minutes until 120 minutes after injection). 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 16 Jul 2018.