Healthy VolunteersPhase 2NCT02351804
Does Perineural Dexamethasone Prolong Duration of a Nerve Block?
A Phase 2 study testing Ropivacaine + dexamethasone in people with Healthy Volunteers, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate whether dexamethasone as an adjuvant to ropivacaine for adductor canal block increases duration of the sensory block, when controlling for a systemic effect using a paired design and bilateral blocks. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Ropivacaine + dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2015to Mar 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 to 30 years
- Men only
- Healthy volunteers accepted
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital
Gentofte Municipality, Hellerup, 2900
About this study
Official title: Does Perineural Dexamethasone Prolong Duration of an Adductor Canal Block When Controlling for a Systemic Effect? A Paired, Randomized, Blinded, Study in Healthy Volunteers
The purpose of this study is to investigate whether dexamethasone as an adjuvant to ropivacaine for adductor canal block increases duration of the sensory block, when controlling for a systemic effect using a paired design and bilateral blocks.
The investigators hypothesize that adding dexamethasone to ropivacaine will prolong block duration compared with ropivacaine + placebo.
- Conditions
- Healthy Volunteers
- Being tested
- Ropivacaine + dexamethasone, Ropivacaine + placebo
- Keywords
- US-guided peripheral nerve block, Anesthetics, Local, duration, Sensation, adductor canal block, lower limb, Adjuvants, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine + dexamethasoneDrug
Adductor canal block, single bolus
Ropivacaine + placeboDrug
Adductor canal block, single bolus
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine + dexamethasone | Experimental | 20 ml ropivacaine 0.5% + 0.5 ml dexamethasone 4 mg7ml Receives: Drug: Ropivacaine + dexamethasone |
| Ropivacaine + placebo | Placebo comparator | 20 ml ropivacaine 0.5% + 0.5 ml isotonic saline ad Receives: Drug: Ropivacaine + 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 dexamethasone 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, except at 2 and 3 hours post block where there will be a break and no assessments will be performed.
Measured: 0-36 hours
Secondary outcomes (5)
Difference between dexamethasone 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 (except at 2 and 3 hours post block where there will be a break and no assessments will be performed).
Measured: 0-36 hours
Difference between dexamethasone 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 (except at 2 and 3 hours post block where there will be a break and no assessments will be performed).
Recovery of normal sensation is defined as VAS pain scores ± 10 mm of the pre-block value.
Measured: 0-36 hours
Difference between dexamethasone 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 (except at 2 and 3 hours post block where there will be a break and no assessments will be performed and only assessed if pain scores during tonic heat stimulation is above 0 ).
Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value.
Measured: 0-36 hours
Difference between dexamethasone 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 (except at 2 and 3 hours post block where there will be a break and no assessments will be performed and only assessed if pain scores during tonic heat stimulation is above 0 ).
Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value.
Measured: 0-36 hours
Difference in maximum pain scores between dexamethasone and placebo during block and after recovery of normal sensation
Pain scores during a tonic heat stimulation will be compared at 4 h post block and 1 h after pain scores have returned to the pre-block values.
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 posted30 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pia Jaeger, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Pia Jæger, MD, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351804
- Sponsor's protocol ID
- SM2-PJ-14
- Other IDs
- 2014-004879-23, 2014
- Status last verified
- Aug 2015
- First submitted
- 27 Jan 2015
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Perineural Dexamethasone Prolong Duration of an Adductor Canal Block When Controlling for a Systemic Effect? A Paired, Randomized, Blinded, Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02351804
- Acronym / sponsor ID
- SM2-PJ-14
- Conditions
- Healthy Volunteers
- Keywords
- US-guided peripheral nerve block, Anesthetics, Local, duration, Sensation, adductor canal block, lower limb, Adjuvants, Anesthesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 30 Jan 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 purpose of this study is to investigate whether dexamethasone as an adjuvant to ropivacaine for adductor canal block increases duration of the sensory block, when controlling for a systemic effect using a paired design and bilateral blocks.
The investigators hypothesize that adding dexamethasone to ropivacaine will prolong block duration compared with ropivacaine + placebo.
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 + dexamethasone | Experimental | Drug: Ropivacaine + dexamethasone20 ml ropivacaine 0.5% + 0.5 ml dexamethasone 4 mg7ml |
| Ropivacaine + placebo | Placebo comparator | Drug: Ropivacaine + placebo20 ml ropivacaine 0.5% + 0.5 ml isotonic saline ad |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- 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 + dexamethasoneAdductor canal block, single bolus | Drug | Ropivacaine + dexamethasone |
| Ropivacaine + placeboAdductor canal block, single bolus | Drug | Ropivacaine + placebo |
Primary outcome
Difference in duration of sensory block between dexamethasone 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, except at 2 and 3 hours post block where there will be a break and no assessments will be performed.
5 secondary outcomes
Difference between dexamethasone and placebo in the duration of a sensory block assessed by pin-prick
Time frame: 0-36 hours
Difference between dexamethasone 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 dexamethasone and placebo in the duration of a sensory block assessed as warmth detection threshold
Time frame: 0-36 hours
Difference between dexamethasone and placebo in the duration of a sensory block assessed as heat pain detection threshold
Time frame: 0-36 hours
Difference in maximum pain scores between dexamethasone 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 Sep 2015.
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Screening Protocol
Pain
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.
Pia Jæger, MD, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
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 + dexamethasone in people with Healthy Volunteers, run by Copenhagen University Hospital, Rigshospitalet 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 Sep 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 dexamethasone 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 Sep 2015.