Postoperative PainPhase 4NCT02829697
The Effect of Local Anaesthetic Volume on Nerve Block Duration and Nerve Block Duration Variability
A Phase 4 study testing Ropivacaine in people with Postoperative Pain, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
The aim is to investigate the effect of perineural administration of a series of different volumes of local anaesthesia (ropivacaine 0.2%) on nerve block duration and the variability of the duration in the common peroneal nerve and the sciatic nerve in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- 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
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2016to 20 Mar 2017
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female 18-64 years
- American Society of Anesthesiologists Classification ≤ II
Who cannot join
- Body Mass Index ≤ 18 or ≥ 30
- Former surgery to the lower extremities
- Peripheral nerve disease
- Allergy to ropivacaine
- 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: The Effect of Local Anaesthetic Volume on Nerve Block Duration and Nerve Block Duration Variability. A Randomised, Blinded, Healthy Volunteer Study
The aim is to investigate the effect of perineural administration of a series of different volumes of local anaesthesia (ropivacaine 0.2%) on nerve block duration and the variability of the duration in the common peroneal nerve and the sciatic nerve in healthy volunteers.
The hypothesis is that nerve block duration is correlated to local anaesthetic volume, but only to a certain degree. After a sufficient volume a 'saturation level' will be reached, and nerve block duration will not increase further.
Read the detailed description
The trial is divided into two similar phases. Each phase will focus on a specific nerve. Phase 1 will focus on the common peroneal nerve and Phase 2 will focus on the sciatic nerve.
After baseline measurements, the investigators will insert a peripheral intravenous catheter. Then, the investigators will insert a suture-method peripheral nerve catheter (Certa CatheterTM). Procedures will be done in a sterile manner as a standard of practice. The investigators will use an ultrasound (US)-guided short-axis, needle in-plane technique. For the US-scan, the investigators will use a linear or a curvilinear transducer.
During interventions, volunteers will be monitored with continuous pulse oximetry. Placement of the peripheral nerve catheter will be facilitated by US using small injections of mepivacaine (carbocaine 2 %) in the skin and surrounding tissues and only isotonic saline (5 mL) in the perineural space to prevent blocking of the nerve before ropivacaine injection. The catheter orifice will be placed by pulling either end of the catheter and guided by the built-in echogenic markings seen on US. Before injection of ropivacaine, the investigators will do careful aspirations through the catheter in order to prevent intravasal injection.
Each ropivacaine injection will be administered via an infusion pump. This will ensure a constant infusion rate set to 10 mL per minute. During infusion, the volunteers will be monitored with continuous pulse oximetry.
Before instigation of the ropivacaine infusion, the investigators will use US to verify full absorption of the isotonic saline in the perineural space.
For each nerve, the subject will be randomly allocated to and receive one of five possible ropivacaine volumes. All volunteers and outcome assessors will be blinded to the ropivacaine administrations and infusion procedures. Outcome assessors will not be in the room, when the medication is prepared nor given. Preparation will take place behind a curtain and therefore also blinded to the volunteers.
- Conditions
- Postoperative Pain
- Being tested
- Ropivacaine
- Keywords
- Regional anaesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Perineural injection.
| Study group | Role | What they receive |
|---|---|---|
| Peroneal nerve: Ropivacaine 0.2%, 2.5 mL | Active comparator | Perineural injection of ropivacaine 0.2 %, 2,5 mL Receives: Drug: Ropivacaine |
| Peroneal nerve: Ropivacaine 0.2%, 5 mL | Active comparator | Perineural injection of ropivacaine 0.2 %, 5 mL Receives: Drug: Ropivacaine |
| Peroneal nerve: Ropivacaine 0.2%, 10 mL | Active comparator | Perineural injection of ropivacaine 0.2 %, 10 mL Receives: Drug: Ropivacaine |
| Peroneal nerve: Ropivacaine 0.2%, 15 mL | Active comparator | Perineural injection of ropivacaine 0.2 %, 15 mL Receives: Drug: Ropivacaine |
| Peroneal nerve: Ropivacaine 0.2%, 20 mL | Active comparator | Perineural injection of ropivacaine 0.2 %, 20 mL Receives: Drug: Ropivacaine |
| Sciatic nerve: Ropivacaine 0.2%, 5 mL | Active comparator | Perineural injection of ropivacaine 0.2 %, 5 mL Receives: Drug: Ropivacaine |
| Sciatic nerve: Ropivacaine 0.2%, 10 mL | Active comparator | Perineural injection of ropivacaine 0.2 %, 10 mL Receives: Drug: Ropivacaine |
| Sciatic nerve: Ropivacaine 0.2%, 15 mL | Active comparator | Perineural injection of ropivacaine 0.2 %, 15 mL Receives: Drug: Ropivacaine |
| Sciatic nerve: Ropivacaine 0.2%, 20 mL | Active comparator | Perineural injection of ropivacaine 0.2 %, 20 mL Receives: Drug: Ropivacaine |
| Sciatic nerve: Ropivacaine 0.2%, 30 mL | Active comparator | Perineural injection of ropivacaine 0.2 %, 30 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
Application of a round, cooled glass container in the sensory distribution area of the tested nerve: The lateral part of the lower leg for the common peroneal nerve and beneath the foot for the tibial nerve. Testing will start after onset of sensory nerve block and continue until normal sensation has returned. When testing the sciatic nerve, we will continue testing until normal sensation has returned in both components of the nerve, i.e. the tibial and common peroneal nerve.
Measured: 1-24 hours
Secondary outcomes (5)
Length of nerve exposed to local anaesthesia
We will measure local anaesthetic spread in a proximal-to-distal manner parallel to the nerve trajectory. Total length of the neural spread will be reported in millimetres from the most proximal point to the most distal point in which fluid, i.e. ropivacaine, is seen on ultrasound in proximity to the nerve. Testing will be done immediately after end of ropivacaine infusion.
Measured: 10 minutes
Onset of sensory nerve block
Application of a round, cooled glass container in the sensory distribution area of the tested nerve: The lateral part of the lower leg for the common peroneal nerve and beneath the foot for the tibial nerve. Testing will start ten minutes after end of infusion and continue for every fifth minute until onset. We will test for a maximum of 180 minutes.
Measured: 10-180 minutes
Onset of motor nerve block
Testing will start ten minutes after end of infusion and continue for every fifth minute until onset. When onset of sensory nerve block is confirmed, testing of motor nerve block onset will end as well, if not already found. Motor nerve block of the tibial nerve will be evaluated by plantarflexion of the ankle. Motor nerve block of the common peroneal nerve will be tested by dorsiflexion of the ankle.
Measured: 10-180 minutes
Degree of sensory nerve block
We will test sensory nerve block using a subjective rating scale. We will grade from one to four: 1) "not different from ipsilateral antebrachium"; 2) "different from ipsilateral antebrachium"; 3) "warm sensation"; 4) "no sensation". Grades 2-4 will be considered as successful sensory nerve blocks. It will be noted if the volunteer is in doubt. Nevertheless, this will be considered as a successful sensory nerve block and graded as 2) in the post hoc statistical analyses.
Measured: 1-24 hours
Degree of motor nerve block
This will be tested with the volunteer in the upright position using a sturdy counter for balance if necessary. Motor strength will be evaluated using a normal everyday activation of the lower leg: A toe and a heel raise, testing the common peroneal nerve via activation of the anterior tibial muscle and the tibial nerve via activation of the gastrocnemius muscle, respectively. Motor nerve block intensity will be evaluated on a scale from one to three: 1) normal strength, 2) paresis or 3) paralysis. Volunteers will be asked to perform a maximum contraction building up muscle force over three seconds. It will be noted if the volunteer is in doubt, which will be considered as 2) paresis in the post hoc statistical analyses.
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 posted12 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion20 Mar 2017
- Study completion20 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 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
- Kai Henrik Wiborg Lange, MD DMSC, Study director, Nordsjællands Hospital Hillerød
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829697
- Sponsor's protocol ID
- H-16000184
- Status last verified
- Mar 2017
- First submitted
- 8 Jul 2016
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: We will attach relevant data sheets to all our scientific submissions.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Local Anaesthetic Volume on Nerve Block Duration and Nerve Block Duration Variability. A Randomised, Blinded, Healthy Volunteer Study
- ClinicalTrials.gov ID
- NCT02829697
- Acronym / sponsor ID
- H-16000184
- Conditions
- Postoperative Pain
- Keywords
- Regional anaesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Innovation Fund Denmark
- Study start
- Jul 2016
- Primary completion
- 20 Mar 2017 (actual)
- Study completion
- 20 Mar 2017 (actual)
- First posted
- 12 Jul 2016 (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 is to investigate the effect of perineural administration of a series of different volumes of local anaesthesia (ropivacaine 0.2%) on nerve block duration and the variability of the duration in the common peroneal nerve and the sciatic nerve in healthy volunteers.
The hypothesis is that nerve block duration is correlated to local anaesthetic volume, but only to a certain degree. After a sufficient volume a 'saturation level' will be reached, and nerve block duration will not increase further.
Detailed description
The trial is divided into two similar phases. Each phase will focus on a specific nerve. Phase 1 will focus on the common peroneal nerve and Phase 2 will focus on the sciatic nerve.
After baseline measurements, the investigators will insert a peripheral intravenous catheter. Then, the investigators will insert a suture-method peripheral nerve catheter (Certa CatheterTM). Procedures will be done in a sterile manner as a standard of practice. The investigators will use an ultrasound (US)-guided short-axis, needle in-plane technique. For the US-scan, the investigators will use a linear or a curvilinear transducer.
During interventions, volunteers will be monitored with continuous pulse oximetry. Placement of the peripheral nerve catheter will be facilitated by US using small injections of mepivacaine (carbocaine 2 %) in the skin and surrounding tissues and only isotonic saline (5 mL) in the perineural space to prevent blocking of the nerve before ropivacaine injection. The catheter orifice will be placed by pulling either end of the catheter and guided by the built-in echogenic markings seen on US. Before injection of ropivacaine, the investigators will do careful aspirations through the catheter in order to prevent intravasal injection.
Each ropivacaine injection will be administered via an infusion pump. This will ensure a constant infusion rate set to 10 mL per minute. During infusion, the volunteers will be monitored with continuous pulse oximetry.
Before instigation of the ropivacaine infusion, the investigators will use US to verify full absorption of the isotonic saline in the perineural space.
For each nerve, the subject will be randomly allocated to and receive one of five possible ropivacaine volumes. All volunteers and outcome assessors will be blinded to the ropivacaine administrations and infusion procedures. Outcome assessors will not be in the room, when the medication is prepared nor given. Preparation will take place behind a curtain and therefore also blinded to the volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Peroneal nerve: Ropivacaine 0.2%, 2.5 mL | Active comparator | Drug: RopivacainePerineural injection of ropivacaine 0.2 %, 2,5 mL |
| Peroneal nerve: Ropivacaine 0.2%, 5 mL | Active comparator | Drug: RopivacainePerineural injection of ropivacaine 0.2 %, 5 mL |
| Peroneal nerve: Ropivacaine 0.2%, 10 mL | Active comparator | Drug: RopivacainePerineural injection of ropivacaine 0.2 %, 10 mL |
| Peroneal nerve: Ropivacaine 0.2%, 15 mL | Active comparator | Drug: RopivacainePerineural injection of ropivacaine 0.2 %, 15 mL |
| Peroneal nerve: Ropivacaine 0.2%, 20 mL | Active comparator | Drug: RopivacainePerineural injection of ropivacaine 0.2 %, 20 mL |
| Sciatic nerve: Ropivacaine 0.2%, 5 mL | Active comparator | Drug: RopivacainePerineural injection of ropivacaine 0.2 %, 5 mL |
| Sciatic nerve: Ropivacaine 0.2%, 10 mL | Active comparator | Drug: RopivacainePerineural injection of ropivacaine 0.2 %, 10 mL |
| Sciatic nerve: Ropivacaine 0.2%, 15 mL | Active comparator | Drug: RopivacainePerineural injection of ropivacaine 0.2 %, 15 mL |
| Sciatic nerve: Ropivacaine 0.2%, 20 mL | Active comparator | Drug: RopivacainePerineural injection of ropivacaine 0.2 %, 20 mL |
| Sciatic nerve: Ropivacaine 0.2%, 30 mL | Active comparator | Drug: RopivacainePerineural injection of ropivacaine 0.2 %, 30 mL |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male or female 18-64 years
- American Society of Anesthesiologists Classification ≤ II
Key exclusion criteria (8 listed)
- Body Mass Index ≤ 18 or ≥ 30
- Former surgery to the lower extremities
- Peripheral nerve disease
- Allergy to ropivacaine
- 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 |
|---|---|---|
| RopivacainePerineural injection. | Drug | Peroneal nerve: Ropivacaine 0.2%, 10 mL, Peroneal nerve: Ropivacaine 0.2%, 15 mL, Peroneal nerve: Ropivacaine 0.2%, 2.5 mL, Peroneal nerve: Ropivacaine 0.2%, 20 mL, Peroneal nerve: Ropivacaine 0.2%, 5 mL, Sciatic nerve: Ropivacaine 0.2%, 10 mL, Sciatic nerve: Ropivacaine 0.2%, 15 mL, Sciatic nerve: Ropivacaine 0.2%, 20 mL, Sciatic nerve: Ropivacaine 0.2%, 30 mL, Sciatic nerve: Ropivacaine 0.2%, 5 mL |
Primary outcome
Duration of sensory nerve block
Time frame: 1-24 hours
Application of a round, cooled glass container in the sensory distribution area of the tested nerve: The lateral part of the lower leg for the common peroneal nerve and beneath the foot for the tibial nerve. Testing will start after onset of sensory nerve block and continue until normal sensation has returned. When testing the sciatic nerve, we will continue testing until normal sensation has returned in both components of the nerve, i.e. the tibial and common peroneal nerve.
5 secondary outcomes
Length of nerve exposed to local anaesthesia
Time frame: 10 minutes
Onset of sensory nerve block
Time frame: 10-180 minutes
Onset of motor nerve block
Time frame: 10-180 minutes
Degree of sensory nerve block
Time frame: 1-24 hours
Degree 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 22 Mar 2017.
- Individual participant dataSharing planned: Yes. We will attach relevant data sheets to all our scientific submissions.
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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.
Kai Henrik Wiborg Lange, MD DMSC study director
Nordsjællands Hospital Hillerød
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 Postoperative Pain, 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 22 Mar 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. 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?
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 22 Mar 2017.