HealthyPhase 2NCT03222323
Perineural Dexmedetomidine for Ulnar Nerve Block.
A Phase 2 study testing Dexmedetomidine perineurally, Ropivacaine 5mg/ml and Ropivacaine 7.5mg/ml in people with Healthy, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The aim of this trial is to investigate if dexmedetomidine prolongs the duration of an ulnar nerve block. By using healthy volunteers the investigators can perform bilateral ulnar nerve blocks and thereby control for a systemic effect to clarify if the effect is actually peripheral or systemic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dexmedetomidine perineurally, Ropivacaine 5mg/ml and Ropivacaine 7.5mg/ml
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Jul 2017to 1 Apr 2018
- Phase
- Phase 2
- 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
- Participants must understand the protocol fully and sign the written in-formed consent.
- ASA 1-2
- BMI > 18 to < 30
- For fertile women: safe contraceptives for the last month and a nega-tive urin HCG.
Who cannot join
- Participants unable to cooperate in the trial.
- Participants unable to speak or read Danish
- Allergy to study medication.
- Alcohol consumption >21 units for men and >14 for women per week
- Daily intake of prescription painkillers within the last 4 weeks.
- Over the counter painkillers during the last 48 hours.
Show all 11Show fewer
- Neuromuscular defects or wounds on the arms or hands preventing test performance.
- Diabetes Mellitus
- 2. degree heart block
- Sick sinus node.
- For fertile women a positive urine HCG
Trial locations and contacts
1 site in 1 country.
Ole Mathiesen, M.D. Ph.D. contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Anesthesiology Zealand University Hospital
Køge, 4600
Jakob H Andersen, MD, 004560610666, JAHEA@regionsjaelland.dk
Jakob H Andersen, MD
About this study
Official title: Does Perineural Dexmedetomidine Prolong the Duration of an Ulnar Nerve Block When Controlling for Possible Systemic Effects?
The aim of this trial is to investigate if dexmedetomidine prolongs the duration of an ulnar nerve block. By using healthy volunteers the investigators can perform bilateral ulnar nerve blocks and thereby control for a systemic effect to clarify if the effect is actually peripheral or systemic. The investigators hypothesis is that dexmedetomidine as an adjunct to a local anaesthetic prolongs the duration of a peripheral nerve block by a peripheral mechanism.
Read the detailed description
Background:
Efficient pain management promoting mobilization and convalescence is essential in an ideal perioperative course. Regional nerve blocks are a central element in postoperative regimes for many patients and it is therefore important that these nerve blocks are both long lasting and efficient. This trial will investigate whether it is possible to optimize the postoperative pain management when adding dexmedetomidine to the local anaesthetic ropivacaine in peripheral nerve blocks.
The prolonging effect of using dexmedetomidine as adjunct in peripheral nerve blocks have been investigated in several studies. However, it remains uncertain whether the effect is mediated by a systemic-, a peripheral- or a combined systemic/peripheral mechanism. In this trial the adjuvating effect of dexmedetomidine will be investigated using an ulnar nerve block.
Method:
The participants will attend two trial days.
On one trial day the volunteers will receive bilateral ulnar nerve blocks. In one arm they will receive the local anaesthetic ropivacaine 4ml 5mg/ml and placebo (saline) and in the other arm ropivacaine 4ml 5mg/ml and dexmedetomidine 100μg. The dexmedetomidine administered perineurally is absorbed and redistributed and will influence the two nerve blocks equally systemically. On the other trial day the participants will receive ropivacaine 4ml 5mg/ml and placebo (saline) and in the other arm ropivacaine 4ml 7.5mg/ml and placebo (saline). The allocation is blinded to volunteer and investigator.
In this setup we therefore have a perineural- and a systemic dexmedetomidine group and also a placebo group , and a group testing if higher doses of local anesthetics will prolong the duration of a nerve block.
The duration of the nerve block will be measured by 3 different tests: pinprick, temperature test (alcohol) and Pain during tonic heat stimulation. All tests are validated within pain research.
- Conditions
- Healthy
- Being tested
- Dexmedetomidine perineurally, Ropivacaine 5mg/ml, Ropivacaine 7.5mg/ml, Dexmedetomidine systemically, Isotonic saline
- Keywords
- volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine perineurallyDrug
Also called Dexdor
Dexmedetomidine is added perineurally on one side and will influence the nerve block perineurally on this side. Dexmedetomidine is also absorbed and redistributed systemically and will influence the opposite ulnar nerve block systemically.
Ropivacaine 5mg/mlDrug
Also called Naropine
Ropivacaine is used in 5mg/ml in the perineural, systemic and placebo nerve blocks.
Ropivacaine 7.5mg/mlDrug
Also called Naropine
In the high dose ropivacaine group a ropivacaine concentration of 7.5mg/ml is used.
Dexmedetomidine systemicallyDrug
Also called dexdor
Dexmedetomidine administered perineurally on one side is absorbed and redistributed systemically and will influence the opposite ulnar nerve block systemically.
Isotonic salineDrug
Also called Placebo
placebo (saline) is administered perineurally in all but the perineural group.
| Study group | Role | What they receive |
|---|---|---|
| Perineural dexmedetomidine | Experimental | Ulnar nerve block 4ml ropivacaine 5mg/ml + 1ml 100ug/ml dexmedetomidine perineurally Receives: Drug: Dexmedetomidine perineurally; Drug: Ropivacaine 5mg/ml |
| Systemic dexmedetomidine | Active comparator | Ulnar nerve block 4ml ropivacaine 5mg/ml + 1ml isotonic saline (placebo) perineurally + 100ug dexmedetomidine systemically (absorbed and redistributed from the opposite ulnar nerve block) Receives: Drug: Ropivacaine 5mg/ml; Drug: Dexmedetomidine systemically; Drug: Isotonic saline |
| Placebo | Placebo comparator | Ulnar nerve block 4ml ropivacaine 5mg/ml + 1ml isotonic saline (placebo) perineurally Receives: Drug: Ropivacaine 5mg/ml; Drug: Isotonic saline |
| High dose Ropivacaine | Active comparator | Ulnar nerve block 4ml ropivacaine 7.5mg/ml + 1ml isotonic saline (placebo) perineurally Receives: Drug: Ropivacaine 7.5mg/ml; Drug: Isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in duration of sensory nerve block assessed by mechanical discrimination (pinprick) between perineural dexmedetomidine and placebo
Duration of sensory nerve block measured by mechanical discrimination (pinprick) defined as time from block performance (removal of the needle) until the needle feels sharp again.
Measured: 0-36 hours
Difference in duration of sensory nerve block assessed by mechanical discrimination (pinprick) between systemic dexmedetomidine and placebo
Duration of sensory nerve block measured by mechanical discrimination (pinprick) defined as time from block performance (removal of the needle) until the needle feels sharp again.
Measured: 0-36 hours
Difference in duration of sensory nerve block assessed by mechanical discrimination (pinprick) between systemic dexmedetomidine and perineural dexmedetomidine
Duration of sensory nerve block measured by mechanical discrimination (pinprick) defined as time from block performance (removal of the needle) until the needle feels sharp again.
Measured: 0-36 hours
Secondary outcomes (17)
Difference in duration of sensory nerve block assessed by mechanical discrimination (pinprick) between high dose ropivacaine and placebo
Duration of sensory nerve block measured by mechanical discrimination (pinprick) defined as time from block performance (removal of the needle) until the needle feels sharp again.
Measured: 0-36 hours
Difference in duration of sensory nerve block assessed by temperature discrimination between perineural dexmedetomidine and placebo
Duration of sensory nerve block measured by temperature discrimination defined as time from block performance (removal of the needle) until the stimulation with an alcohol swab feels cold again.
Measured: 0-36 hours
Difference in duration of sensory nerve block assessed by temperature discrimination between systemic dexmedetomidine and placebo
Duration of sensory nerve block measured by temperature discrimination defined as time from block performance (removal of the needle) until the stimulation with an alcohol swab feels cold again.
Measured: 0-36 hours
Difference in duration of sensory nerve block assessed by temperature discrimination between systemic dexmedetomidine and perineural dexmedetomidine
Duration of sensory nerve block measured by temperature discrimination defined as time from block performance (removal of the needle) until the stimulation with an alcohol swab feels cold again.
Measured: 0-36 hours
Difference in duration of sensory nerve block assessed by temperature discrimination between high dose ropivacaine and placebo
Duration of sensory nerve block measured by temperature discrimination defined as time from block performance (removal of the needle) until the stimulation with an alcohol swab feels cold again.
Measured: 0-36 hours
Difference in duration of sensory nerve block assessed by pain during tonic heat stimulation between perineural dexmedetomidine and placebo
Duration of sensory nerve block measured by pain during tonic heat stimulation defined as time from block performance (removal of the needle) until a thermode heated to 45C for 30 seconds elicits a painful response again (VAS>0)
Measured: 0-36 hours
Difference in duration of sensory nerve block assessed by pain during tonic heat stimulation between systemic dexmedetomidine and placebo
Duration of sensory nerve block measured by pain during tonic heat stimulation defined as time from block performance (removal of the needle) until a thermode heated to 45C for 30 seconds elicits a painful response again (VAS>0)
Measured: 0-36 hours
Difference in duration of sensory nerve block assessed by pain during tonic heat stimulation between perineural dexmedetomidine and systemic dexmedetomidine
Duration of sensory nerve block measured by pain during tonic heat stimulation defined as time from block performance (removal of the needle) until a thermode heated to 45C for 30 seconds elicits a painful response again (VAS>0)
Measured: 0-36 hours
Difference in duration of sensory nerve block assessed by pain during tonic heat stimulation between high dose ropivacaine and placebo
Duration of sensory nerve block measured by pain during tonic heat stimulation defined as time from block performance (removal of the needle) until a thermode heated to 45C for 30 seconds elicits a painful response again (VAS>0)
Measured: 0-36 hours
Difference in duration of motor nerve block assessed by maximum voluntary isometric contraction between perineural dexmedetomidine and placebo
Duration of motor nerve block measured by maximum voluntary isometric contraction is defined as time from block performance (removal of the needle) until fifth finger abduction maximal voluntary isometric contraction (MVIC) > 75% of baseline value, or the participant indicates return of normal motor funktion.
Measured: 0-36 hours
Difference in duration of motor nerve block assessed by maximum voluntary isometric contraction between systemic dexmedetomidine and placebo
Duration of motor nerve block measured by maximum voluntary isometric contraction is defined as time from block performance (removal of the needle) until fifth finger abduction maximal voluntary isometric contraction (MVIC) > 75% of baseline value, or the participant indicates return of normal motor funktion.
Measured: 0-36 hours
Difference in duration of motor nerve block assessed by maximum voluntary isometric contraction between systemic dexmedetomidine and perineural dexmedetomidine
Duration of motor nerve block meassured by maximum voluntary isometric contraction is defined as time from block performance (removal of the needle) until fifth finger abduction maximal voluntary isometric contraction (MVIC) > 75% of baseline value, or the participant indicates return of normal motor funktion.
Measured: 0-36 hours
Difference in duration of motor nerve block assessed by maximum voluntary isometric contraction between high dose ropivacaine and placebo
Duration of motor nerve block measured by maximum voluntary isometric contraction is defined as time from block performance (removal of the needle) until fifth finger abduction maximal voluntary isometric contraction (MVIC) > 75% of baseline value, or the participant indicates return of normal motor funktion.
Measured: 0-36 hours
Difference in onset of sensory nerve block assessed by mechanical discrimination (pinprick) between perineural dexmedetomidine and placebo
Onset of sensory nerve block assessed by mechanical discrimination (pinprick) is defined as time from block performance (removal of the needle) until the needle stops feeling sharp.
Measured: 0-36 hours
Difference in onset of sensory nerve block assessed by mechanical discrimination (pinprick) between systemic dexmedetomidine and placebo
Onset of sensory nerve block assessed by mechanical discrimination (pinprick) is defined as time from block performance (removal of the needle) until the needle stops feeling sharp.
Measured: 0-36 hours
Difference in onset of sensory nerve block assessed by mechanical discrimination (pinprick) between perineural dexmedetomidine and systemic dexmedetomidine
Onset of sensory nerve block assessed by mechanical discrimination (pinprick) is defined as time from block performance (removal of the needle) until the needle stops feeling sharp.
Measured: 0-36 hours
Difference in onset of sensory nerve block assessed by mechanical discrimination (pinprick) between high dose ropivacaine and placebo
Onset of sensory nerve block assessed by mechanical discrimination (pinprick) is defined as time from block performance (removal of the needle) until the needle stops feeling sharp.
Measured: 0-36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start17 Jul 2017
- Primary completion1 Jan 2018 (estimated)
- Study completion1 Apr 2018 (estimated)
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 HealthyStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants will attend two trial days and receive two treatments on each trial days
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakob Hessel Andersen, Zealand University Hospital
- Investigators
- Jakob H Andersen, M.D., Principal investigator, Department of Anesthesiology, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222323
- Sponsor's protocol ID
- REG-158-2016
- Other IDs
- 2016-004883-20, 2016
- Status last verified
- Jul 2017
- First submitted
- 17 Jul 2017
- Last updated
- 31 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Andersen JH, Jaeger P, Grevstad U, Estrup S, Geisler A, Vilhelmsen F, Dahl JB, Laier GH, Ilfeld BM, Mathiesen O. Systemic dexmedetomidine is not as efficient as perineural dexmedetomidine in prolonging an ulnar nerve block. Reg Anesth Pain Med. 2019 Mar;44(3):333-340. doi: 10.1136/rapm-2018-100089. Epub 2019 Jan 23.
PubMed 30679332
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Perineural Dexmedetomidine Prolong the Duration of an Ulnar Nerve Block When Controlling for Possible Systemic Effects?
- ClinicalTrials.gov ID
- NCT03222323
- Acronym / sponsor ID
- REG-158-2016
- Conditions
- Healthy
- Keywords
- volunteers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 1 Jan 2018 (estimated)
- Study completion
- 1 Apr 2018 (estimated)
- First posted
- 19 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.
The aim of this trial is to investigate if dexmedetomidine prolongs the duration of an ulnar nerve block. By using healthy volunteers the investigators can perform bilateral ulnar nerve blocks and thereby control for a systemic effect to clarify if the effect is actually peripheral or systemic. The investigators hypothesis is that dexmedetomidine as an adjunct to a local anaesthetic prolongs the duration of a peripheral nerve block by a peripheral mechanism.
Detailed description
Background:
Efficient pain management promoting mobilization and convalescence is essential in an ideal perioperative course. Regional nerve blocks are a central element in postoperative regimes for many patients and it is therefore important that these nerve blocks are both long lasting and efficient. This trial will investigate whether it is possible to optimize the postoperative pain management when adding dexmedetomidine to the local anaesthetic ropivacaine in peripheral nerve blocks.
The prolonging effect of using dexmedetomidine as adjunct in peripheral nerve blocks have been investigated in several studies. However, it remains uncertain whether the effect is mediated by a systemic-, a peripheral- or a combined systemic/peripheral mechanism. In this trial the adjuvating effect of dexmedetomidine will be investigated using an ulnar nerve block.
Method:
The participants will attend two trial days.
On one trial day the volunteers will receive bilateral ulnar nerve blocks. In one arm they will receive the local anaesthetic ropivacaine 4ml 5mg/ml and placebo (saline) and in the other arm ropivacaine 4ml 5mg/ml and dexmedetomidine 100μg. The dexmedetomidine administered perineurally is absorbed and redistributed and will influence the two nerve blocks equally systemically. On the other trial day the participants will receive ropivacaine 4ml 5mg/ml and placebo (saline) and in the other arm ropivacaine 4ml 7.5mg/ml and placebo (saline). The allocation is blinded to volunteer and investigator.
In this setup we therefore have a perineural- and a systemic dexmedetomidine group and also a placebo group , and a group testing if higher doses of local anesthetics will prolong the duration of a nerve block.
The duration of the nerve block will be measured by 3 different tests: pinprick, temperature test (alcohol) and Pain during tonic heat stimulation. All tests are validated within pain research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The participants will attend two trial days and receive two treatments on each trial days
| Arm | Type | Receives |
|---|---|---|
| Perineural dexmedetomidine | Experimental | Drug: Dexmedetomidine perineurally, Drug: Ropivacaine 5mg/mlUlnar nerve block 4ml ropivacaine 5mg/ml + 1ml 100ug/ml dexmedetomidine perineurally |
| Systemic dexmedetomidine | Active comparator | Drug: Ropivacaine 5mg/ml, Drug: Dexmedetomidine systemically, Drug: Isotonic salineUlnar nerve block 4ml ropivacaine 5mg/ml + 1ml isotonic saline (placebo) perineurally + 100ug dexmedetomidine systemically (absorbed and redistributed from the opposite ulnar nerve block) |
| Placebo | Placebo comparator | Drug: Ropivacaine 5mg/ml, Drug: Isotonic salineUlnar nerve block 4ml ropivacaine 5mg/ml + 1ml isotonic saline (placebo) perineurally |
| High dose Ropivacaine | Active comparator | Drug: Ropivacaine 7.5mg/ml, Drug: Isotonic salineUlnar nerve block 4ml ropivacaine 7.5mg/ml + 1ml isotonic saline (placebo) perineurally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must understand the protocol fully and sign the written in-formed consent.
- ASA 1-2
- BMI > 18 to < 30
- For fertile women: safe contraceptives for the last month and a nega-tive urin HCG.
Key exclusion criteria (11 listed)
- Participants unable to cooperate in the trial.
- Participants unable to speak or read Danish
- Allergy to study medication.
- Alcohol consumption >21 units for men and >14 for women per week
- Daily intake of prescription painkillers within the last 4 weeks.
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 |
|---|---|---|
| Dexmedetomidine perineurallyAlso: DexdorDexmedetomidine is added perineurally on one side and will influence the nerve block perineurally on this side. Dexmedetomidine is also absorbed and redistributed systemically and will influence the opposite ulnar nerve block systemically. | Drug | Perineural dexmedetomidine |
| Ropivacaine 5mg/mlAlso: NaropineRopivacaine is used in 5mg/ml in the perineural, systemic and placebo nerve blocks. | Drug | Perineural dexmedetomidine, Placebo, Systemic dexmedetomidine |
| Ropivacaine 7.5mg/mlAlso: NaropineIn the high dose ropivacaine group a ropivacaine concentration of 7.5mg/ml is used. | Drug | High dose Ropivacaine |
| Dexmedetomidine systemicallyAlso: dexdorDexmedetomidine administered perineurally on one side is absorbed and redistributed systemically and will influence the opposite ulnar nerve block systemically. | Drug | Systemic dexmedetomidine |
| Isotonic salineAlso: Placeboplacebo (saline) is administered perineurally in all but the perineural group. | Drug | High dose Ropivacaine, Placebo, Systemic dexmedetomidine |
Primary outcome
Difference in duration of sensory nerve block assessed by mechanical discrimination (pinprick) between perineural dexmedetomidine and placebo
Time frame: 0-36 hours
Duration of sensory nerve block measured by mechanical discrimination (pinprick) defined as time from block performance (removal of the needle) until the needle feels sharp again.
Difference in duration of sensory nerve block assessed by mechanical discrimination (pinprick) between systemic dexmedetomidine and placebo
Time frame: 0-36 hours
Duration of sensory nerve block measured by mechanical discrimination (pinprick) defined as time from block performance (removal of the needle) until the needle feels sharp again.
Difference in duration of sensory nerve block assessed by mechanical discrimination (pinprick) between systemic dexmedetomidine and perineural dexmedetomidine
Time frame: 0-36 hours
Duration of sensory nerve block measured by mechanical discrimination (pinprick) defined as time from block performance (removal of the needle) until the needle feels sharp again.
17 secondary outcomes
Difference in duration of sensory nerve block assessed by mechanical discrimination (pinprick) between high dose ropivacaine and placebo
Time frame: 0-36 hours
Difference in duration of sensory nerve block assessed by temperature discrimination between perineural dexmedetomidine and placebo
Time frame: 0-36 hours
Difference in duration of sensory nerve block assessed by temperature discrimination between systemic dexmedetomidine and placebo
Time frame: 0-36 hours
Difference in duration of sensory nerve block assessed by temperature discrimination between systemic dexmedetomidine and perineural dexmedetomidine
Time frame: 0-36 hours
Difference in duration of sensory nerve block assessed by temperature discrimination between high dose ropivacaine and placebo
Time frame: 0-36 hours
Difference in duration of sensory nerve block assessed by pain during tonic heat stimulation between perineural dexmedetomidine and placebo
Time frame: 0-36 hours
Difference in duration of sensory nerve block assessed by pain during tonic heat stimulation between systemic dexmedetomidine and placebo
Time frame: 0-36 hours
Difference in duration of sensory nerve block assessed by pain during tonic heat stimulation between perineural dexmedetomidine and systemic dexmedetomidine
Time frame: 0-36 hours
Difference in duration of sensory nerve block assessed by pain during tonic heat stimulation between high dose ropivacaine and placebo
Time frame: 0-36 hours
Difference in duration of motor nerve block assessed by maximum voluntary isometric contraction between perineural dexmedetomidine and placebo
Time frame: 0-36 hours
Difference in duration of motor nerve block assessed by maximum voluntary isometric contraction between systemic dexmedetomidine and placebo
Time frame: 0-36 hours
Difference in duration of motor nerve block assessed by maximum voluntary isometric contraction between systemic dexmedetomidine and perineural dexmedetomidine
Time frame: 0-36 hours
Difference in duration of motor nerve block assessed by maximum voluntary isometric contraction between high dose ropivacaine and placebo
Time frame: 0-36 hours
Difference in onset of sensory nerve block assessed by mechanical discrimination (pinprick) between perineural dexmedetomidine and placebo
Time frame: 0-36 hours
Difference in onset of sensory nerve block assessed by mechanical discrimination (pinprick) between systemic dexmedetomidine and placebo
Time frame: 0-36 hours
Difference in onset of sensory nerve block assessed by mechanical discrimination (pinprick) between perineural dexmedetomidine and systemic dexmedetomidine
Time frame: 0-36 hours
Difference in onset of sensory nerve block assessed by mechanical discrimination (pinprick) between high dose ropivacaine and placebo
Time frame: 0-36 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
- Derived from this study: PubMed 30679332Andersen JH, Jaeger P, Grevstad U, Estrup S, Geisler A, Vilhelmsen F, Dahl JB, Laier GH, Ilfeld BM, Mathiesen O. Systemic dexmedetomidine is not as efficient as perineural dexmedetomidine in prolonging an ulnar nerve block. Reg Anesth Pain Med. 2019 Mar;44(3):333-340. doi: 10.1136/rapm-2018-100089. Epub 2019 Jan 23.
- Individual participant dataSharing planned: Undecided
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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.
Ole Mathiesen, M.D. Ph.D. contact
Jakob H Andersen, M.D. principal investigator
Department of Anesthesiology, Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexmedetomidine perineurally, Ropivacaine 5mg/ml and Ropivacaine 7.5mg/ml in people with Healthy, run by Zealand University Hospital 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 31 Jul 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jakob H Andersen, M.D. (+4560610666, Jahea@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in duration of sensory nerve block assessed by mechanical discrimination (pinprick) between perineural dexmedetomidine and placebo (time frame: 0-36 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03222323, 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 31 Jul 2017.