Anesthesia, LocalPhase 2NCT04817982
Does Perineural Dexamethasone Increase the Duration of an Ulnar Nerve Block When Controlling for Systemic Effects?
A Phase 2 study testing Perineural dexamethasone, Lidocaine and Systemic dexamethasone in people with Anesthesia, Local, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Investigators will assess if perineural dexamethasone can increase the duration of an ulnar nerve block when controlling for systemic effects in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Perineural dexamethasone, Lidocaine and Systemic dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Apr 2021to 15 May 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of 18 years or above
- Must fully understand the protocol and sign written informed consent
- American Society of Anaesthesiologists Physical Status Classification System of 1 or 2
- Body Mass Index above 18 kg/m^2
- For fertile women, safe contraceptives for the last month and negative urine human chorionic gonadotropin is required
Who cannot join
- Participants unable to cooperate
- Participants unable to speak or read Danish
- Age above 65 years
- Cardiovascular disease
- Allergy to study medication
- History of alcohol or substance abuse
Show all 11Show fewer
- Intake of corticosteroids within the last 14 days
- Daily intake of prescription analgesia within the last four weeks
- Intake of over-the-counter analgesia within the last 48 hours
- Neuromuscular diseases or wounds on the arms or hands preventing adequate test or block performance.
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Zealand University Hospital
Køge, Zealand Region of Denmark, 4600
About this study
Official title: Does Perineural Dexamethasone Increase the Duration of an Ulnar Nerve Block When Controlling for Systemic Effects? A Randomised, Blinded, Placebo-controlled, Paired, Non-inferiority Trial in Healthy Volunteers.
Investigators will assess if perineural dexamethasone can increase the duration of an ulnar nerve block when controlling for systemic effects in healthy volunteers.
Read the detailed description
Healthy volunteers will have bilateral ulnar nerve blocks performed with bupivacaine on two different days with a minimum of 14 days wash-out. On one day, the participants will also receive dexamethasone in one arm and placebo in the other. On the other day, the participants will also receive placebo in one arm and lidocaine in the other. By this using this design, the investigators will be able to assess if perineural dexamethasone can increase the duration of an ulnar nerve block when controlling for the systemic effects. Furthermore, to ensure blinding, the investigators have also incorporated the lidocaine group which also allows for the assessment of the effects of adding lidocaine to a peripheral nerve block with bupivacaine. The order of which the participant will receive dexamethasone and lidocaine will be random. It will also be random in which arm the participant receives dexamethasone and lidocaine.
- Conditions
- Anesthesia, Local
- Being tested
- Perineural dexamethasone, Lidocaine, Placebo, Systemic dexamethasone
- Keywords
- Regional anesthesia, Dexamethasone, Peripheral nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineural dexamethasoneDrug
Dexamethasone 4mg will be added perineurally to an ulnar nerve block with bupivacaine.
LidocaineDrug
Lidocaine 40 mg will be added perineurally to an ulnar nerve block with bupivacaine.
PlaceboDrug
Also called Saline
Saline will be added perineurally to an ulnar nerve block with bupivacaine.
Systemic dexamethasoneDrug
Dexamethasone will be added perineurally to an ulnar nerve block with bupivacaine, some will be reabsorbed and distributed systemically. Thereby, the investigators control for the systemic effects of adding perineural dexamethasone to an ulnar nerve block.
| Study group | Role | What they receive |
|---|---|---|
| Perineural dexamethasone | Experimental | Bilateral ulnar nerve blocks with bupivacaine. Dexamethasone will be added perineurally in this arm on the same day as the 'systemic dexamethasone' group. Receives: Drug: Perineural dexamethasone |
| Systemic dexamethasone | Active comparator | Bilateral ulnar nerve blocks with bupivacaine. Placebo (saline) will be added perineurally in this arm on the same day as the 'perineural dexamethasone' group. Thereby, this ulnar nerve block will only be affected by the perineurally added dexamethasone that is absorbed and redistributed systemically. Receives: Drug: Systemic dexamethasone |
| Placebo | Placebo comparator | Bilateral ulnar nerve blocks with bupivacaine. Placebo (saline) will be added perineurally in this arm on the same day as lidocaine group. This will be the actual placebo group. Receives: Drug: Placebo |
| Perineural lidocaine | Active comparator | Bilateral ulnar nerve blocks with bupivacaine. Lidocaine will be added perineurally in this arm on the same day as the actual placebo group. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the sensory nerve block, assessed by temperature discrimination (cold swab)
The investigators will stimulate the skin with an alcohol swab and ask the participant if it is cold or warm. The duration of the sensory block will be defined as the time to the alcohol swab feels cold again. The investigators will assess temperature discrimination every 30 minutes.
Measured: 24 hours
Secondary outcomes (4)
Duration of the sensory nerve block, assessed by mechanical discrimination (pinprick)
The investigators will stimulate the skin with a needle. The duration of the sensory block will be defined as the time to the needle feels sharp again. The investigators will assess mechanical discrimination every 30 minutes.
Measured: 24 hours
Duration of analgesia, assessed by pain during tonic heat stimulation (heated thermode)
The investigators will stimulate the participants' skin for 30 seconds with a thermode heated to 45 degrees Celsius. The participants rate the pain elicited on the Visual Analogue Scale using a ruler indicating "no pain" at zero millimetre on one end and "worst perceivable pain" at 100 millimetres at the opposite end. The duration of the sensory block will be defined as the time to the tonic heat stimulation elicits a painful response of Visual Analogue Scale above '0'. The investigators will assess pain every 30 minutes.
Measured: 24 hours
Duration of the motor block, assessed by fifth finger abduction
The hand is placed facing with the volar side upwards. The hand is constricted so that only the fifth finger can abduct. The motor block is assessed using a Modified Bromage Scale. The duration of motor block is the time from block performance until Bromage grade '4' is reached or the participant indicates a feeling of normal strength in the finger.
Measured: 24 hours
Onset of the sensory nerve block, assessed by temperature discrimination (cold swab)
The investigators will stimulate the skin with an alcohol swab and ask the participant if it is cold or warm. The onset of the sensory block will be defined as the time to the alcohol swab no longer feels cold. The investigators will assess the onset by temperature discrimination every 5 minutes.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start7 Apr 2021
- Primary completion15 May 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies 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
- Model description
- Randomised, blinded, placebo-controlled, paired, non-inferiority trial in healthy volunteers.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathias Maagaard, MD, Principal investigator, Zealand University Hospital, Køge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817982
- Sponsor's protocol ID
- REG-138-2020
- Status last verified
- Jun 2021
- First submitted
- 23 Mar 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Patient Data will be shared upon reasonable request from researchers.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Perineural Dexamethasone Increase the Duration of an Ulnar Nerve Block When Controlling for Systemic Effects? A Randomised, Blinded, Placebo-controlled, Paired, Non-inferiority Trial in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT04817982
- Acronym / sponsor ID
- REG-138-2020
- Conditions
- Anesthesia, Local
- Keywords
- Regional anesthesia, Dexamethasone, Peripheral nerve block
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 26 Mar 2021 (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.
Investigators will assess if perineural dexamethasone can increase the duration of an ulnar nerve block when controlling for systemic effects in healthy volunteers.
Detailed description
Healthy volunteers will have bilateral ulnar nerve blocks performed with bupivacaine on two different days with a minimum of 14 days wash-out. On one day, the participants will also receive dexamethasone in one arm and placebo in the other. On the other day, the participants will also receive placebo in one arm and lidocaine in the other. By this using this design, the investigators will be able to assess if perineural dexamethasone can increase the duration of an ulnar nerve block when controlling for the systemic effects. Furthermore, to ensure blinding, the investigators have also incorporated the lidocaine group which also allows for the assessment of the effects of adding lidocaine to a peripheral nerve block with bupivacaine. The order of which the participant will receive dexamethasone and lidocaine will be random. It will also be random in which arm the participant receives dexamethasone and lidocaine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomised, blinded, placebo-controlled, paired, non-inferiority trial in healthy volunteers.
| Arm | Type | Receives |
|---|---|---|
| Perineural dexamethasone | Experimental | Drug: Perineural dexamethasoneBilateral ulnar nerve blocks with bupivacaine. Dexamethasone will be added perineurally in this arm on the same day as the 'systemic dexamethasone' group. |
| Systemic dexamethasone | Active comparator | Drug: Systemic dexamethasoneBilateral ulnar nerve blocks with bupivacaine. Placebo (saline) will be added perineurally in this arm on the same day as the 'perineural dexamethasone' group. Thereby, this ulnar nerve block will only be affected by the perineurally added dexamethasone that is absorbed and redistributed systemically. |
| Placebo | Placebo comparator | Drug: PlaceboBilateral ulnar nerve blocks with bupivacaine. Placebo (saline) will be added perineurally in this arm on the same day as lidocaine group. This will be the actual placebo group. |
| Perineural lidocaine | Active comparator | Drug: LidocaineBilateral ulnar nerve blocks with bupivacaine. Lidocaine will be added perineurally in this arm on the same day as the actual placebo group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age of 18 years or above
- Must fully understand the protocol and sign written informed consent
- American Society of Anaesthesiologists Physical Status Classification System of 1 or 2
- Body Mass Index above 18 kg/m^2
- For fertile women, safe contraceptives for the last month and negative urine human chorionic gonadotropin is required
Key exclusion criteria (11 listed)
- Participants unable to cooperate
- Participants unable to speak or read Danish
- Age above 65 years
- Cardiovascular disease
- Allergy to study medication
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 |
|---|---|---|
| Perineural dexamethasoneDexamethasone 4mg will be added perineurally to an ulnar nerve block with bupivacaine. | Drug | Perineural dexamethasone |
| LidocaineLidocaine 40 mg will be added perineurally to an ulnar nerve block with bupivacaine. | Drug | Perineural lidocaine |
| PlaceboAlso: SalineSaline will be added perineurally to an ulnar nerve block with bupivacaine. | Drug | Placebo |
| Systemic dexamethasoneDexamethasone will be added perineurally to an ulnar nerve block with bupivacaine, some will be reabsorbed and distributed systemically. Thereby, the investigators control for the systemic effects of adding perineural dexamethasone to an ulnar nerve block. | Drug | Systemic dexamethasone |
Primary outcome
Duration of the sensory nerve block, assessed by temperature discrimination (cold swab)
Time frame: 24 hours
The investigators will stimulate the skin with an alcohol swab and ask the participant if it is cold or warm. The duration of the sensory block will be defined as the time to the alcohol swab feels cold again. The investigators will assess temperature discrimination every 30 minutes.
4 secondary outcomes
Duration of the sensory nerve block, assessed by mechanical discrimination (pinprick)
Time frame: 24 hours
Duration of analgesia, assessed by pain during tonic heat stimulation (heated thermode)
Time frame: 24 hours
Duration of the motor block, assessed by fifth finger abduction
Time frame: 24 hours
Onset of the sensory nerve block, assessed by temperature discrimination (cold swab)
Time frame: 24 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 2021.
- Individual participant dataSharing planned: Yes. Individual Patient Data will be shared upon reasonable request from researchers.
Related trials for Anesthesia, Local
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
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.
Mathias Maagaard, MD principal investigator
Zealand University Hospital, Køge
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 Perineural dexamethasone, Lidocaine and Systemic dexamethasone in people with Anesthesia, Local, 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 5 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: finished, as of the sponsor's last update on 1 Jul 2021. 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?
Duration of the sensory nerve block, assessed by temperature discrimination (cold swab) (time frame: 24 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 2021.