PainNCT02456597
A Novel Concept for Continuous Peripheral Nerve Block - Sciatic Nerve
A study testing lidocainhydrochlorid and Isotonic Saline in people with Pain, run by Kai Henrik Wiborg Lange.
Trial summary
To investigate the function of a novel catheter for continuous peripheral nerve blocks in the popliteal nerve: Two key issues are investigated 1) Successful primary placement and function of the catheter for continuous peripheral nerve blocks confirmed by a decrease in motor function following injection of local… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- lidocainhydrochlorid and Isotonic Saline
- 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 2015to Jun 2015
- 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
- Male or female ≥18 years of age at Visit X.
- ASA classification ≤ II
- Written informed consent obtained from volunteer and ability for volunteer to comply with the requirements of the study.
Who cannot join
- BMI ≥ 30
- Previous or ongoing surgery, pain or other disability of investigated region.
- Prescriptive drugs other than anti-contraceptive.
- Sensory or neurologic deficits in the investigated region
- Allergy to LA
- Pregnancy, breastfeeding, or unwilling to practice birth control during participation in the study.-
About this study
Official title: A Novel Concept for Continuous Peripheral Nerve Block - Popliteal Region
To investigate the function of a novel catheter for continuous peripheral nerve blocks in the popliteal nerve: Two key issues are investigated 1) Successful primary placement and function of the catheter for continuous peripheral nerve blocks confirmed by a decrease in motor function following injection of local analgesics through the catheter; 2) The rate of displacement after standardized movement of the limb where the catheter for continuous peripheral nerve blocks is inserted.
Read the detailed description
Although peripheral nerve blocks are known to provide superior postoperative analgesia. Continuous peripheral nerve block (CPNB) are not used to the extent they deserve. This is predominantly due to variable success rates. Furthermore, the existing techniques for placing catheters for CPNBs are technically complicated and time consuming.4,5 Major problems include difficult insertion of the catheter tip past the needle, difficult visualization of catheter advancement, secondary displacement of the local anesthetic (LA) injection orifice(s) and limited possibility of repositioning the catheter once it has been left in situ. We have developed a new catheter for CPNBs to address and overcome these limitations.
Hence, the new catheter should primarily provide precise initial placement of the catheter, less risk of secondary displacement and a possibility to readjust the new catheter at any time point after initial placement. Furthermore, in-plane ultrasound (US) visualization during the entire procedure and during readjustment should be possible. The new catheter should also provide a simple and rapid technique with few components. Initial proof of concept studies in cadavers are promising with success rates close to 100 % both for initial placement and readjustment
- Conditions
- Pain
- Being tested
- lidocainhydrochlorid, Isotonic Saline
- Keywords
- Peripheral Nerve Blocks
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocainhydrochloridDrug
Also called Lidocaine, Xylocaine
Lidocaine injected through the novel Catheter
Isotonic SalineDrug
Also called Saline
Isotonic saline injected through the novel Catheter
| Study group | Role | What they receive |
|---|---|---|
| lidocainhydrochlorid | Active comparator | Lidocaine 20mg/ml, 15 ml injected perineural at the sciatic nerve Receives: Drug: lidocainhydrochlorid |
| Isotonic saline | Placebo comparator | 0.9% Saline Solution, 15ml injected perineural at the contralateral sciatic nerve Receives: Drug: Isotonic Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle force (dynamometer) change from baseline
Decreased muscle force measured with a dynamometer after intervention
Measured: an average of three months
Secondary outcomes (3)
Surface EMG (sEMG) change from baseline
Decreased EMG response (mV) after intervention
Measured: an average of three months
Displacement of catheter (mm) change from initial placement
Displacement of catheter in millimeters assessed by ultrasound
Measured: an average of three months
Cutaneous Sensory Mapping (Decreased sensibility in the region innervated by Tibial and Popliteal nerves) change from baseline
Decreased sensibility in the region innervated by Tibial and Popliteal nerves
Measured: an average of three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kai Henrik Wiborg Lange
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kai Henrik Wiborg Lange, Hillerod Hospital, Denmark
- Investigators
- Christian Rothe, Principal investigator, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456597
- Sponsor's protocol ID
- H-15000927
- Status last verified
- Oct 2015
- First submitted
- 1 Apr 2015
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Concept for Continuous Peripheral Nerve Block - Popliteal Region
- ClinicalTrials.gov ID
- NCT02456597
- Acronym / sponsor ID
- H-15000927
- Conditions
- Pain
- Keywords
- Peripheral Nerve Blocks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Kai Henrik Wiborg LangeUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 May 2015 (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.
To investigate the function of a novel catheter for continuous peripheral nerve blocks in the popliteal nerve: Two key issues are investigated 1) Successful primary placement and function of the catheter for continuous peripheral nerve blocks confirmed by a decrease in motor function following injection of local analgesics through the catheter; 2) The rate of displacement after standardized movement of the limb where the catheter for continuous peripheral nerve blocks is inserted.
Detailed description
Although peripheral nerve blocks are known to provide superior postoperative analgesia. Continuous peripheral nerve block (CPNB) are not used to the extent they deserve. This is predominantly due to variable success rates. Furthermore, the existing techniques for placing catheters for CPNBs are technically complicated and time consuming.4,5 Major problems include difficult insertion of the catheter tip past the needle, difficult visualization of catheter advancement, secondary displacement of the local anesthetic (LA) injection orifice(s) and limited possibility of repositioning the catheter once it has been left in situ. We have developed a new catheter for CPNBs to address and overcome these limitations.
Hence, the new catheter should primarily provide precise initial placement of the catheter, less risk of secondary displacement and a possibility to readjust the new catheter at any time point after initial placement. Furthermore, in-plane ultrasound (US) visualization during the entire procedure and during readjustment should be possible. The new catheter should also provide a simple and rapid technique with few components. Initial proof of concept studies in cadavers are promising with success rates close to 100 % both for initial placement and readjustment
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocainhydrochlorid | Active comparator | Drug: lidocainhydrochloridLidocaine 20mg/ml, 15 ml injected perineural at the sciatic nerve |
| Isotonic saline | Placebo comparator | Drug: Isotonic Saline0.9% Saline Solution, 15ml injected perineural at the contralateral sciatic nerve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female ≥18 years of age at Visit X.
- ASA classification ≤ II
- Written informed consent obtained from volunteer and ability for volunteer to comply with the requirements of the study.
Key exclusion criteria (6 listed)
- BMI ≥ 30
- Previous or ongoing surgery, pain or other disability of investigated region.
- Prescriptive drugs other than anti-contraceptive.
- Sensory or neurologic deficits in the investigated region
- Allergy to LA
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 |
|---|---|---|
| lidocainhydrochloridAlso: Lidocaine, XylocaineLidocaine injected through the novel Catheter | Drug | lidocainhydrochlorid |
| Isotonic SalineAlso: SalineIsotonic saline injected through the novel Catheter | Drug | Isotonic saline |
Primary outcome
Muscle force (dynamometer) change from baseline
Time frame: an average of three months
Decreased muscle force measured with a dynamometer after intervention
3 secondary outcomes
Surface EMG (sEMG) change from baseline
Time frame: an average of three months
Displacement of catheter (mm) change from initial placement
Time frame: an average of three months
Cutaneous Sensory Mapping (Decreased sensibility in the region innervated by Tibial and Popliteal nerves) change from baseline
Time frame: an average of three months
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 15 Oct 2015.
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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.
Christian Rothe principal investigator
Nordsjaellands Hospital
Questions about this trial
What is this clinical trial studying?
A study testing lidocainhydrochlorid and Isotonic Saline in people with Pain, run by Kai Henrik Wiborg Lange.
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 3 inclusion and 6 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 15 Oct 2015. 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?
Muscle force (dynamometer) change from baseline (time frame: an average of three months). 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 15 Oct 2015.