Percutaneous Electric Nerve StimulationPhase 4NCT00176111
Effects of Local Anesthetic or Saline Solution on Peripheral Nerve Stimulation - a Randomised Study
A Phase 4 study testing peripheral nerve stimulation (procedure) in people with Percutaneous Electric Nerve Stimulation, run by Heidelberg University at 1 site in Germany.
Trial summary
In this study we want to examine the effect of a small amount of local anesthetic or saline solution on nerve conduction using a peripheral nerve stimulator. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Percutaneous Electric Nerve Stimulation
- What is being tested?
- peripheral nerve stimulation (procedure)
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2004to Jan 2005
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA 1-2
Who cannot join
- peripheral neuropathy, ASA >2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Local Anesthetic or Saline Solution on Peripheral Nerve Stimulation - a Randomised, Double-Blind, Multicenter Study About the Stimulability of Anesthetized Nerves
In this study we want to examine the effect of a small amount of local anesthetic or saline solution on nerve conduction using a peripheral nerve stimulator.
Read the detailed description
Using electrical nerve stimulation in performing peripheral nerve helps to control the needle position in relation to the nerve and therefore may increase the likelihood of a successful nerve block. Defining the minimal stimulating current accepted also may help to avoid direct contact between nerve and needle or accidental endoneural injection and subsequent nerve lesion.
In recent years there have been many reports where several nerves, parts thereof or plexuses have been anesthetised using a multiple injection approach. That is, nerves in close proximity of each other have been subsequently blocked after using a nerve stimulator to locate them.
It is not clear though, whether a nerve may already be partially anesthetised in this situation and whether that would impair the correct use of a peripheral nerve stimulator.
The aim of this study is to examine the excitability of a peripheral nerve after injecting a small amount of local anesthetic agent or saline solution into the proximity of the nerve.
- Conditions
- Percutaneous Electric Nerve Stimulation
- Being tested
- peripheral nerve stimulation (procedure)
- Keywords
- peripheral nerve stimulation, saline, local anesthestics, regional anesthestia, nerve damage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral nerve stimulation (procedure)Procedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startJan 2004
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Electric Nerve StimulationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Rechbergklinik Bretten
- Investigators
- Heinz Kaiser, MD, Study chair, Rechbergklinik Bretten
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00176111
- Sponsor's protocol ID
- nervstim001
- Status last verified
- Jan 2004
- First submitted
- 12 Sep 2005
- Last updated
- 17 Nov 2005
- Results posted
- No
Publications
Neuburger M, Gultlinger O, Ass B, Buttner J, Kaiser H. [Influence of blockades with local anesthetics on the stimulation ability of a nerve by peripheral nerve stimulation. Results of a randomized study]. Anaesthesist. 2005 Jun;54(6):575-7. doi: 10.1007/s00101-005-0824-3. German.
PubMed 15739091
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Local Anesthetic or Saline Solution on Peripheral Nerve Stimulation - a Randomised, Double-Blind, Multicenter Study About the Stimulability of Anesthetized Nerves
- ClinicalTrials.gov ID
- NCT00176111
- Acronym / sponsor ID
- nervstim001
- Conditions
- Percutaneous Electric Nerve Stimulation
- Keywords
- peripheral nerve stimulation, saline, local anesthestics, regional anesthestia, nerve damage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Rechbergklinik Bretten
- Study start
- Jan 2004
- Study completion
- Jan 2005
- First posted
- 15 Sep 2005 (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.
In this study we want to examine the effect of a small amount of local anesthetic or saline solution on nerve conduction using a peripheral nerve stimulator.
Detailed description
Using electrical nerve stimulation in performing peripheral nerve helps to control the needle position in relation to the nerve and therefore may increase the likelihood of a successful nerve block. Defining the minimal stimulating current accepted also may help to avoid direct contact between nerve and needle or accidental endoneural injection and subsequent nerve lesion.
In recent years there have been many reports where several nerves, parts thereof or plexuses have been anesthetised using a multiple injection approach. That is, nerves in close proximity of each other have been subsequently blocked after using a nerve stimulator to locate them.
It is not clear though, whether a nerve may already be partially anesthetised in this situation and whether that would impair the correct use of a peripheral nerve stimulator.
The aim of this study is to examine the excitability of a peripheral nerve after injecting a small amount of local anesthetic agent or saline solution into the proximity of the nerve.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA 1-2
Key exclusion criteria (1 listed)
- peripheral neuropathy, ASA >2
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 |
|---|---|---|
| peripheral nerve stimulation (procedure) | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2005.
- Results publication: PubMed 15739091Neuburger M, Gultlinger O, Ass B, Buttner J, Kaiser H. [Influence of blockades with local anesthetics on the stimulation ability of a nerve by peripheral nerve stimulation. Results of a randomized study]. Anaesthesist. 2005 Jun;54(6):575-7. doi: 10.1007/s00101-005-0824-3. German.
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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.
Heinz Kaiser, MD study chair
Rechbergklinik Bretten
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 peripheral nerve stimulation (procedure) in people with Percutaneous Electric Nerve Stimulation, run by Heidelberg University at 1 site in Germany.
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 1 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 17 Nov 2005. 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 Germany. 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. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00176111, which also lists 1 linked publication.
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 17 Nov 2005.