HealthyPhase 2NCT02444559
Does Perineural Clonidine Prolong Duration of a Nerve Block?
A Phase 2 study testing Ropivacaine 20ml 5mg/ml+ Clonidine 150ug 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 clonidine prolongs the duration of an adductor canal block. By using healthy volunteers the investigators can perform a bilateral adductor canal block 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 older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ropivacaine 20ml 5mg/ml+ Clonidine 150ug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- May 2015to Jun 2015
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists class 1
- Body Mass Index 18-30
Who cannot join
- Allergy to study medication
- Earlier trauma or surgery to lower limb
- Diabetes Mellitus
- Alcohol or drug abuse
- Daily intake of opioids or steroids last 4 weeks
- Daily intake of any analgesics last 48 hours Heart block Sick sinus node.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Perineural Clonidine Prolong the Duration of an Adductor Canal Block When Controlling for a Systemic Effect? - A Randomised Paired Trial in Healthy Volunteers.
The aim of this trial is to investigate if clonidine prolongs the duration of an adductor canal block. By using healthy volunteers the investigators can perform a bilateral adductor canal block and thereby control for a systemic effect to clarify if the effect is actually peripheral or systemic. The investigators hypothesis is that clonidine/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 clonidine to the local anaesthetic ropivacaine in peripheral nerve blocks.
The prolonging effect of using clonidine as adjuncts 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 clonidine will be investigated using the adductor canal block. This is a nerve block that besides being efficient as pain treatment after knee surgery, is primarily sensory, and therefore augments mobilization after total knee arthroplasty.
Method:
On the trial day the volunteers will receive bilateral adductor canal blocks. In one thigh they will receive the local anaesthetic ropivacaine 20ml 5mg/ml and placebo (saline) and in the other thigh ropivacaine 20ml 5mg/ml and Clonidine 150μg. The allocation is blinded to volunteer and investigator.
The duration of the nerve block will be measured by five different tests: Temperature test, Pinprick, Pain during tonic heat stimulation, Warmth detection threshold and pain detection threshold. All tests are validated within pain research.
- Conditions
- Healthy
- Being tested
- Ropivacaine 20ml 5mg/ml+ Clonidine 150ug, Ropivacaine 20ml 5mg/ml+ Placebo
- Keywords
- Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 20ml 5mg/ml+ Clonidine 150ugDrug
Ropivacaine 20ml 5mg/ml+ PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine+Clonidine | Experimental | Adductor Canal Block Ropivacaine 20ml 5mg/ml+ Clonidine 150ug Receives: Drug: Ropivacaine 20ml 5mg/ml+ Clonidine 150ug |
| Ropivacaine+Placebo | Placebo comparator | Adductor Canal Block Ropivacaine 20ml 5mg/ml+ saline Receives: Drug: Ropivacaine 20ml 5mg/ml+ Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in duration of sensory block between clonidine and placebo assessed as cold sensation with an alcohol swab
Duration is defined as time from block performance until recovery of cold sensation to an alcohol swab, assessed every hour post-block (and every half hour when pain scores during the tonic heat stimulation test is above 0) Time for sleep will be provided.
Measured: 0-36 hours
Secondary outcomes (5)
Difference between Clonidine and placebo in the duration of a sensory block assessed by pin-prick
Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block Time for sleep will be provided.
Measured: 0-36 hours
Difference between clonidine and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test
Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block Time for sleep will be provided. Recovery of normal sensation is defined as VAS pain scores ± 10 mm of the pre-block value.
Measured: 0-36 hours
Difference between clonidine and placebo in the duration of a sensory block assessed as warmth detection threshold
Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block Time for sleep will be provided. Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value.
Measured: 0-36 hours
Difference between clonidine and placebo in the duration of a sensory block assessed as heat pain detection threshold
Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block. Time for sleep will be provided. Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value.
Measured: 0-36 hour
Difference in maximum pain scores between clonidine and placebo during block and after recovery of normal sensation.
Pain scores during a tonic heat stimulation will be compared every hour post block and 1 h after pain scores have returned to the pre-block values. Time for sleep will be provided.
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 posted14 May 2015 (estimated)
- Study startMay 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 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
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, MD, Principal investigator, Department of Anesthesiology Koege Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444559
- Sponsor's protocol ID
- SM1-JH-14
- Other IDs
- 2014-005640-18, 2014
- Status last verified
- Jun 2015
- First submitted
- 12 May 2015
- Last updated
- 1 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Perineural Clonidine Prolong the Duration of an Adductor Canal Block When Controlling for a Systemic Effect? - A Randomised Paired Trial in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT02444559
- Acronym / sponsor ID
- SM1-JH-14
- Conditions
- Healthy
- Keywords
- Volunteers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 14 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.
The aim of this trial is to investigate if clonidine prolongs the duration of an adductor canal block. By using healthy volunteers the investigators can perform a bilateral adductor canal block and thereby control for a systemic effect to clarify if the effect is actually peripheral or systemic. The investigators hypothesis is that clonidine/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 clonidine to the local anaesthetic ropivacaine in peripheral nerve blocks.
The prolonging effect of using clonidine as adjuncts 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 clonidine will be investigated using the adductor canal block. This is a nerve block that besides being efficient as pain treatment after knee surgery, is primarily sensory, and therefore augments mobilization after total knee arthroplasty.
Method:
On the trial day the volunteers will receive bilateral adductor canal blocks. In one thigh they will receive the local anaesthetic ropivacaine 20ml 5mg/ml and placebo (saline) and in the other thigh ropivacaine 20ml 5mg/ml and Clonidine 150μg. The allocation is blinded to volunteer and investigator.
The duration of the nerve block will be measured by five different tests: Temperature test, Pinprick, Pain during tonic heat stimulation, Warmth detection threshold and pain detection threshold. All tests are validated within pain research.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine+Clonidine | Experimental | Drug: Ropivacaine 20ml 5mg/ml+ Clonidine 150ugAdductor Canal Block Ropivacaine 20ml 5mg/ml+ Clonidine 150ug |
| Ropivacaine+Placebo | Placebo comparator | Drug: Ropivacaine 20ml 5mg/ml+ PlaceboAdductor Canal Block Ropivacaine 20ml 5mg/ml+ saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists class 1
- Body Mass Index 18-30
Key exclusion criteria (6 listed)
- Allergy to study medication
- Earlier trauma or surgery to lower limb
- Diabetes Mellitus
- Alcohol or drug abuse
- Daily intake of opioids or steroids 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 |
|---|---|---|
| Ropivacaine 20ml 5mg/ml+ Clonidine 150ug | Drug | Ropivacaine+Clonidine |
| Ropivacaine 20ml 5mg/ml+ Placebo | Drug | Ropivacaine+Placebo |
Primary outcome
Difference in duration of sensory block between clonidine and placebo assessed as cold sensation with an alcohol swab
Time frame: 0-36 hours
Duration is defined as time from block performance until recovery of cold sensation to an alcohol swab, assessed every hour post-block (and every half hour when pain scores during the tonic heat stimulation test is above 0) Time for sleep will be provided.
5 secondary outcomes
Difference between Clonidine and placebo in the duration of a sensory block assessed by pin-prick
Time frame: 0-36 hours
Difference between clonidine and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test
Time frame: 0-36 hours
Difference between clonidine and placebo in the duration of a sensory block assessed as warmth detection threshold
Time frame: 0-36 hours
Difference between clonidine and placebo in the duration of a sensory block assessed as heat pain detection threshold
Time frame: 0-36 hour
Difference in maximum pain scores between clonidine and placebo during block and after recovery of normal sensation.
Time frame: 0-36 hours
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 1 Jul 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.
Jakob H Andersen, MD principal investigator
Department of Anesthesiology Koege 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 Ropivacaine 20ml 5mg/ml+ Clonidine 150ug 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 2 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 1 Jul 2015. 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?
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?
Difference in duration of sensory block between clonidine and placebo assessed as cold sensation with an alcohol swab (time frame: 0-36 hours). 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 1 Jul 2015.