Peripheral Nerve BlockPhase 4NCT03326609
Local Anesthetic Concentration and Nerve Block Duration
A Phase 4 study testing Ropivacaine in people with Peripheral Nerve Block, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
Background: Local anesthetic (LA) concentration and nerve block duration is sparsely described in a heterogenic study mass. Aim: To investigate the effect of LA concentration on peripheral nerve block duration in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Nerve Block
- What is being tested?
- Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Oct 2017to 5 Jan 2018
- Phase
- Phase 4
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female from and above 18 years of age
- ASA classification ≤ II
Who cannot join
- BMI below 18 kg/m2
- Former surgery to the lower extremity in which intervention is planned and surgery which may have caused neural damage to the common peroneal nerve/affected the sensory distribution area of the common peroneal nerve
- Peripheral nerve disease
- Allergy to LA
- Pregnancy or breastfeeding
- Enrolment in other investigational drug studies or recent clinical trials that may interfere with this study
- Habitual use of any kind of analgesic treatment
- Anatomic abnormalities preventing successful US-guided peripheral nerve catheter insertion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local Anesthetic Concentration and Nerve Block Duration: A Randomized, Blinded Study in Healthy Volunteers
Background: Local anesthetic (LA) concentration and nerve block duration is sparsely described in a heterogenic study mass.
Aim: To investigate the effect of LA concentration on peripheral nerve block duration in healthy volunteers.
Methods: Randomization of 60 healthy volunteers who will receive 1 of 5 different volumes of LA (ropivacaine) using a constant dose.
Primary endpoint: Sensory nerve block defined by insensitivity towards cold.
Read the detailed description
Background:
Important factors for a safe and successful nerve block include volume, dose and concentration of local anesthetic (LA). Knowing the duration of peripheral nerve blocks is important to prevent pain breakthrough. With the advancements in ultrasound (US)-guided nerve block techniques it has been possible to substantially reduce the amount of LA required to perform a successful nerve block. This has reduced the risk of systemic toxicity. However, lowering LA volume may reduce nerve block duration, but the extent of this is sparsely described in a heterogenic study mass.
Diluted and large volumes of LA seem to correlate with nerve block duration. Furthermore, increasing LA concentration seems to increase the level of motor block, but not the block duration. A long-lasting nerve block without dense motor block is preferable for optimized pain control and better opportunities to rehabilitate/ambulate.
Aim:
To investigate the effect of LA concentration on common peroneal nerve block duration in healthy volunteers.
Methods:
Randomization of 60 healthy volunteers who will receive 1 of 5 different volumes of LA (ropivacaine) using a constant dose (10mg).
Primary outcome: Duration of sensory nerve block defined by insensitivity towards cold.
Secondary outcome: Duration of motor nerve block defined by either paresis or paralysis.
Explorative outcomes: Degrees of sensory and motor nerve block; Onset times of sensory and motor nerve block; Length of neural exposure to LA.
- Conditions
- Peripheral Nerve Block
- Being tested
- Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Isotonic saline (natriumchloride)
Perineural injection using a peripheral nerve block catheter and a constant infusion rate (10mL/h)
| Study group | Role | What they receive |
|---|---|---|
| Volume: 2.5 mL | Experimental | Perineural injection of ropivacaine 10 mg, 2.5 mL. Concentration: Ropivacaine 4 mg/mL. Receives: Drug: Ropivacaine |
| Volume: 5 mL | Experimental | Perineural injection of ropivacaine 10 mg, 5 mL. Concentration: Ropivacaine 2 mg/mL Receives: Drug: Ropivacaine |
| Volume: 10 mL | Experimental | Perineural injection of ropivacaine 10 mg, 10 mL Concentration: Ropivacaine 1 mg/mL Receives: Drug: Ropivacaine |
| Volume: 15 mL | Experimental | Perineural injection of ropivacaine 10 mg, 15mL Concentration: Ropivacaine 0.67 mg/mL Receives: Drug: Ropivacaine |
| Volume: 20 mL | Experimental | Perineural injection of ropivacaine 10 mg, 20mL Concentration: Ropivacaine 0.5 mg/mL Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of sensory nerve block
Insensitivity towards cold. Testing will start after onset of sensory nerve block and will be done in intervals of 60 minutes hereafter and continue until return of normal sensation.
Measured: 1-24 hours
Secondary outcomes (1)
Duration of motor nerve block
Paresis or paralysis of ankle dorsiflexion. Testing will start after onset of sensory nerve block and will be done in intervals of 60 minutes hereafter and continue until return of normal sensation.
Measured: 1-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start4 Oct 2017
- Primary completion8 Dec 2017
- Study completion5 Jan 2018
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 Peripheral Nerve BlockStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation Fund Denmark
- Responsible party
- Principal investigator, Claus Behrend Christiansen, Nordsjaellands Hospital
- Investigators
- Claus B Christiansen, MD, Principal investigator, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03326609
- Sponsor's protocol ID
- H-17022555
- Status last verified
- Jan 2018
- First submitted
- 29 Sep 2017
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Christiansen CB, Madsen MH, Molleskov E, Rothe C, Lundstrom LH, Lange KHW. The effect of ropivacaine concentration on common peroneal nerve block duration using a fixed dose: A randomised, double-blind trial in healthy volunteers. Eur J Anaesthesiol. 2020 Apr;37(4):316-322. doi: 10.1097/EJA.0000000000001112.
PubMed 31789898
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Anesthetic Concentration and Nerve Block Duration: A Randomized, Blinded Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03326609
- Acronym / sponsor ID
- H-17022555
- Conditions
- Peripheral Nerve Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Innovation Fund Denmark
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 5 Jan 2018 (actual)
- First posted
- 31 Oct 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.
Background: Local anesthetic (LA) concentration and nerve block duration is sparsely described in a heterogenic study mass.
Aim: To investigate the effect of LA concentration on peripheral nerve block duration in healthy volunteers.
Methods: Randomization of 60 healthy volunteers who will receive 1 of 5 different volumes of LA (ropivacaine) using a constant dose.
Primary endpoint: Sensory nerve block defined by insensitivity towards cold.
Detailed description
Background:
Important factors for a safe and successful nerve block include volume, dose and concentration of local anesthetic (LA). Knowing the duration of peripheral nerve blocks is important to prevent pain breakthrough. With the advancements in ultrasound (US)-guided nerve block techniques it has been possible to substantially reduce the amount of LA required to perform a successful nerve block. This has reduced the risk of systemic toxicity. However, lowering LA volume may reduce nerve block duration, but the extent of this is sparsely described in a heterogenic study mass.
Diluted and large volumes of LA seem to correlate with nerve block duration. Furthermore, increasing LA concentration seems to increase the level of motor block, but not the block duration. A long-lasting nerve block without dense motor block is preferable for optimized pain control and better opportunities to rehabilitate/ambulate.
Aim:
To investigate the effect of LA concentration on common peroneal nerve block duration in healthy volunteers.
Methods:
Randomization of 60 healthy volunteers who will receive 1 of 5 different volumes of LA (ropivacaine) using a constant dose (10mg).
Primary outcome: Duration of sensory nerve block defined by insensitivity towards cold.
Secondary outcome: Duration of motor nerve block defined by either paresis or paralysis.
Explorative outcomes: Degrees of sensory and motor nerve block; Onset times of sensory and motor nerve block; Length of neural exposure to LA.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Volume: 2.5 mL | Experimental | Drug: RopivacainePerineural injection of ropivacaine 10 mg, 2.5 mL. Concentration: Ropivacaine 4 mg/mL. |
| Volume: 5 mL | Experimental | Drug: RopivacainePerineural injection of ropivacaine 10 mg, 5 mL. Concentration: Ropivacaine 2 mg/mL |
| Volume: 10 mL | Experimental | Drug: RopivacainePerineural injection of ropivacaine 10 mg, 10 mL Concentration: Ropivacaine 1 mg/mL |
| Volume: 15 mL | Experimental | Drug: RopivacainePerineural injection of ropivacaine 10 mg, 15mL Concentration: Ropivacaine 0.67 mg/mL |
| Volume: 20 mL | Experimental | Drug: RopivacainePerineural injection of ropivacaine 10 mg, 20mL Concentration: Ropivacaine 0.5 mg/mL |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female from and above 18 years of age
- ASA classification ≤ II
Key exclusion criteria (8 listed)
- BMI below 18 kg/m2
- Former surgery to the lower extremity in which intervention is planned and surgery which may have caused neural damage to the common peroneal nerve/affected the sensory distribution area of the common peroneal nerve
- Peripheral nerve disease
- Allergy to LA
- Pregnancy or breastfeeding
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 |
|---|---|---|
| RopivacaineAlso: Isotonic saline (natriumchloride)Perineural injection using a peripheral nerve block catheter and a constant infusion rate (10mL/h) | Drug | Volume: 10 mL, Volume: 15 mL, Volume: 2.5 mL, Volume: 20 mL, Volume: 5 mL |
Primary outcome
Duration of sensory nerve block
Time frame: 1-24 hours
Insensitivity towards cold. Testing will start after onset of sensory nerve block and will be done in intervals of 60 minutes hereafter and continue until return of normal sensation.
1 secondary outcome
Duration of motor nerve block
Time frame: 1-24 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 8 Jan 2018.
- Derived from this study: PubMed 31789898Christiansen CB, Madsen MH, Molleskov E, Rothe C, Lundstrom LH, Lange KHW. The effect of ropivacaine concentration on common peroneal nerve block duration using a fixed dose: A randomised, double-blind trial in healthy volunteers. Eur J Anaesthesiol. 2020 Apr;37(4):316-322. doi: 10.1097/EJA.0000000000001112.
- Individual participant dataSharing planned: Undecided
Related trials for Peripheral Nerve Block
Not yet recruiting
Blast-related Regional Anaesthesia and Peripheral nerVe Injury Evaluation
Nerve Block, Nerve Blocks
Not yet recruitingObservational study
Nerve Blocks or Combat Trauma: What Drives Peripheral Nerve Injury?
Combat-Related Limb Injury, Nerve Block
Recruiting
Anterior Suprascapular and Axillary vs. Interscalene Block for Analgesia and Diaphragmatic Function in Shoulder Surgery
Peripheral Nerve Block, Pain Management
Recruiting
Comparison of Postoperative Analgesic Effects of Quadro-iliac Plane Block and Transversus Abdominis Plane Blocks in Inguinal Hernia Surgery
Peripheral Nerve Block, Pain Management
Recruiting
Comparison of Analgesic Effects of ACB Versus ACB Combined With BiFeS Block in Meniscopathy Surgery
Meniscopathy Surgery, Peripheral Nerve Block
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.
Claus B Christiansen, MD principal investigator
Nordsjaellands Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine in people with Peripheral Nerve Block, run by Nordsjaellands 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 8 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 8 Jan 2018. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 sensory nerve block (time frame: 1-24 hours). 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 NCT03326609, 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 8 Jan 2018; AzTrials last refreshed its copy on 31 Oct 2026.