Radius Fracture DistalPhase 4NCT06950372
Ropivacaine Concentration and Rebound Pain
A Phase 4 study testing Ropivacaine concentration low and Ropivacaine concentration high in people with Radius Fracture Distal and Rebound Pain, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The goal of this clinical trial is to see if the concentration of a local anesthetic (ropivacaine) in peripheral nerve block is related to the severness of pain after surgery of distal radius fractures in adults. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radius Fracture Distal, Rebound Pain
- What is being tested?
- Ropivacaine concentration low and Ropivacaine concentration high
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteNorway
- Study dates
- 14 Feb 2025to 8 Apr 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with distal radius fracture, scheduled for volar plate surgery
- Surgery up to 20 days after fracture trauma
- 18 to 80 years old (inclusive)
- ASA 1, 2 or stable ASA 3
- Body Mass Index (BMI) 18 to 40 kg/m2 (inclusive)
- Weight of 50 kg or more
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- Ability to communicate sufficiently in a scandinavian language
- Capable of giving a signed informed consent
- Ability and willingness to understand og be compliant to the study
Who cannot join
- Contemporaneous painful injuries
- Existing long-term pain
- Peripheral nerve damage in the arm with radius fracture
- Patients who prior to fracture trauma use opioids, psycothropic drugs or medication, with or without prescription, with significantly sedative effect on regular basis.
- Excessive use of alcohol (more than 15 units of alchol per week for men, more than 8 units of alchol per week for women, or patients reporting to be incapable of avoiding alcohol as long as they use strong opioids).
- Progressive neurologic disease (inclusive diabetic neuropathy).
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- Skin infection at the site for brachial plexus nerve block
- Other contraindications for brachial plexus nerve block
- Contraindications for ropivacaine, paracetamol, etoricoxib, dexamehtasone or oxycodone
- Previous allergic reaction to local anaesthetics or etoricoxib, dexamethasone, oxycodone or paracetamol.
- Pregnant or breast-feeding women at surgery day (they do not get excluded if they become pregnant in the follow up period after intervention and surgery)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rebound Pain After Volar Plate Surgery in Infraclavicular Brachial Plexus Block With Ropivacaine 3.75 mg/ml Compared With 7.5 mg/ml. A Prospective, Parallelgroup, 2-arm, Triple Blinded Randomised Controlled Trial
The goal of this clinical trial is to see if the concentration of a local anesthetic (ropivacaine) in peripheral nerve block is related to the severness of pain after surgery of distal radius fractures in adults.
The main questions it aims to answer are:
Read more
- Is concentration of ropivacaine related to severeness, duration and type of postoperative pain?
- Is concentration of ropivacaine related to analgetic consumption after surgery?
- Is concentration of ropivacaine related to block sucess rate during surgery and patient satisfaction after surgery?
Researchers will compare ropivacaine 3.75 mg/ml and 7.5 mg/ml used in brachial plexus peripheral nerve block. Participipants are randomized to one of the two concentrations. The peripheral nerve block is standard anesthetic treatment for distal radius fractures scheduled for volar plate surgery at Oslo University Hospital. All other treatment for the condition will be the same as standard treatment.
Participants will answer a questionnaire regarding pain, physical function, medication and life quality at different points of time after surgery, up to 6 weeks after surgery.
- Conditions
- Radius Fracture Distal, Rebound Pain
- Being tested
- Ropivacaine concentration low, Ropivacaine concentration high
- Keywords
- Rebound pain, Peripheral nerve block, Distal radius fracture, Brachial plexus block, Ropivacaine
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine concentration lowDrug
Brachial plexus nerve block with ropivacaine 3.75 mg/ml
Ropivacaine concentration highDrug
Brachial plexus nerve block with ropivacaine 7.5 mg/ml
| Study group | Role | What they receive |
|---|---|---|
| Low concentration | Experimental | Ropivacaine 3.75 mg/ml Receives: Drug: Ropivacaine concentration low |
| High concentration | Active comparator | Ropivacaine 7.5 mg/ml Receives: Drug: Ropivacaine concentration high |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worst pain score during the first 48 hours after surgery
Pain score on Verbal Numeric Rating Scale (VNRS) from 0 to 10, where 0 represents no pain at all and 10 represents worst pain imaginable.
Measured: 48 hours after end of surgery
Secondary outcomes (11)
Rebound pain
Number of patients reporting pain score on Verbal Numeric Rating Score (VNRS) of 7 or higher at nerve block resolution, where 0 represents no pain at all and 10 represents worst pain imaginable.
Measured: From end of surgery until nerve block resolution, normally within the first 48 hours after surgery.
Pain score at different points of time after surgery
Pain score 0 to 10 on Verbal Numeric Rating Score (VNRS), where 0 represents no pain at all and 10 represents worst pain imaginable. Pain Score (VNRS 0-10) measured in the Post Anaesthesia Care Unit (PACU) and at 8 hours, 24 hours, 48 hours, 3 days, 7 days and 6 weeks after surgery.
Measured: From baseline, end of surgery, until 6 weeks after surgery.
Duration of moderate and strong pain
Pain measured on Verbal Numeric Rating Score (VNRS) from 0 to 10, where 0 represents no pain at all and 10 represents worst pain imaginable.
Duration of moderate pain, defined as time from VNRS above or equal to 4, after block resolution to first time patient reports VNRS below 4.
Duration of strong pain, defined as time from VNRS above or equal to 7, after block resolution to first time patient reports VNRS below 7.
Measured: From baseline, end of surgery, until first time patient reports VNRS below 7 and/or 4, normally within the first 48 hours.
Average and worst pain experience after surgery at different points of time
Pain measured on Verbal Numeric Rating Score (VNRS) from 0 to 10, where 0 represents no pain at all and 10 represents worst pain imaginable.
Average pain score (VNRS 0-10) at 8-24 hours after surgery, 24-48 hours after surgery, last 24 hours at 3 days and 7 days after surgery.
Worst pain score (VNRS 0-10) at 8-24 hours after surgery, 24-48 hours after surgery, last 24 hours at 3 days and 7 days after surgery.
Measured: From baseline, end of surgery, until 7 days after surgery.
Long-lasting pain
Pain measured on Verbal Numeric Rating Score (VNRS) from 0 to 10, where 0 represents no pain at all and 10 represents worst pain imaginable.
Pain score (VNRS 0-10) at rest and with movement of arm at 6 weeks after surgery.
Worst pain (VNRS 0-10) during last week at 6 weeks after surgery.
Average pain (VNRS 0-10) during last week at 6 weeks after surgery.
Measured: From baseline, end of surgery, until 6 weeks after surgery.
Analgesic consumption after surgery
Total opioid consumption, measured in oral morphine equivalent, first 8 hours, first 24 hours, 24-48 hours, 48-72 hours, 72 hours to 1 week and last week at 6 weeks after surgery.
Total analgesic consumption at the same times as above.
Measured: From baseline, end of surgery, until 6 weeks after surgery.
Duration of motoric and sensoric nerve block
Duration of motoric block: Time from nerve block (needle out) to first time the patient can hold an item with the blocked arm and lift i to the mouth area.
Duration of sensory block: Time from nerve block (needle out) to first sensation of pain.
We will also register time from nerve block (needle out) to first rescue analgesic.
Measured: From intervention, peripheral nerve block (needle out), until motoric and sensory resolution of nerve block, normally within the first 48 hours after intervention.
Life quality
Estimation of pain burden with different quality of life measures at different time points after surgery:
Quality of sleep, work ability, social life and cognitive function using Likert Scale.
Number of patients answering "yes" to the question: "Do you have bothersome pain?".
Measures registered 24 hours, 48 hours, 72 hours, 1 week and 6 weeks after surgery.
Measured: From baseline, end of surgery, until 6 weeks after surgery
Quality of long-term pain
If long-term pain, what type of pain is experienced (heat, cold, burning, prickly, tingling, itchy, squeezing). Registration of pain quality without direct stimulation and after direct stimulation in surgery area and 5-10 cm away from surgery area.
Measured: 6 weeks after baseline, intervention and surgery.
Patient satisfaction
Yes or no to the question; "Are you satisfied with the pain treatment?"
Measured: From enrollment until 6 weeks after surgery
Block success rate
Try to estimate if there is a difference in block success rate between the two concentrations. Sensory and/or motor test of relevant nerves (musculocutaneous, radial, median, ulnar and medial antebrachial cutaneus nerve) before surgery (45 minutes after nerve block and repeated if necessary) and in Post Anesthesia Care Unit (PACU) after surgery.
In addition, yes or no to the question; "Was the block adequate for surgery?" (Registered by anaesthetic personell during surgery)
Measured: From intervention, when nerve block is performed, until 2 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start14 Feb 2025
- Primary completion8 Apr 2026
- Study completion8 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radius Fracture DistalStudies of the same condition, open and under way.
- More trials run by Oslo 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Principal investigator, Anette Aasen, University of Oslo
- Investigators
- Anette Aasen, MD, Anesthesiologist, Principal investigator, University of Oslo and Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950372
- Sponsor's protocol ID
- EU CT 2024-514795-41-00
- Other IDs
- 2024-514795-41-00
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data collected during the trial, after deidentification, will be available in Norwegian at a request. In addition, the Study Protocol is a public document from application moment. Researchers who provide a methodologically sound proposal will receive access to the deidentified individual pariticipant data, to achieve aims in the approved proposal. The data will be available immediately following publication and ending 5 years following article publication. Proposals should be directed to anette.aasen@medicin.uio.no.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rebound Pain After Volar Plate Surgery in Infraclavicular Brachial Plexus Block With Ropivacaine 3.75 mg/ml Compared With 7.5 mg/ml. A Prospective, Parallelgroup, 2-arm, Triple Blinded Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06950372
- Acronym / sponsor ID
- EU CT 2024-514795-41-00
- Conditions
- Radius Fracture Distal, Rebound Pain
- Keywords
- Rebound pain, Peripheral nerve block, Distal radius fracture, Brachial plexus block, Ropivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 8 Apr 2026 (actual)
- Study completion
- 8 Apr 2026 (actual)
- First posted
- 30 Apr 2025 (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.
The goal of this clinical trial is to see if the concentration of a local anesthetic (ropivacaine) in peripheral nerve block is related to the severness of pain after surgery of distal radius fractures in adults.
The main questions it aims to answer are:
- Is concentration of ropivacaine related to severeness, duration and type of postoperative pain?
- Is concentration of ropivacaine related to analgetic consumption after surgery?
- Is concentration of ropivacaine related to block sucess rate during surgery and patient satisfaction after surgery?
Researchers will compare ropivacaine 3.75 mg/ml and 7.5 mg/ml used in brachial plexus peripheral nerve block. Participipants are randomized to one of the two concentrations. The peripheral nerve block is standard anesthetic treatment for distal radius fractures scheduled for volar plate surgery at Oslo University Hospital. All other treatment for the condition will be the same as standard treatment.
Participants will answer a questionnaire regarding pain, physical function, medication and life quality at different points of time after surgery, up to 6 weeks after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low concentration | Experimental | Drug: Ropivacaine concentration lowRopivacaine 3.75 mg/ml |
| High concentration | Active comparator | Drug: Ropivacaine concentration highRopivacaine 7.5 mg/ml |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with distal radius fracture, scheduled for volar plate surgery
- Surgery up to 20 days after fracture trauma
- 18 to 80 years old (inclusive)
- ASA 1, 2 or stable ASA 3
- Body Mass Index (BMI) 18 to 40 kg/m2 (inclusive)
Key exclusion criteria (11 listed)
- Contemporaneous painful injuries
- Existing long-term pain
- Peripheral nerve damage in the arm with radius fracture
- Patients who prior to fracture trauma use opioids, psycothropic drugs or medication, with or without prescription, with significantly sedative effect on regular basis.
- Excessive use of alcohol (more than 15 units of alchol per week for men, more than 8 units of alchol per week for women, or patients reporting to be incapable of avoiding alcohol as long as they use strong opioids).
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 concentration lowBrachial plexus nerve block with ropivacaine 3.75 mg/ml | Drug | Low concentration |
| Ropivacaine concentration highBrachial plexus nerve block with ropivacaine 7.5 mg/ml | Drug | High concentration |
Primary outcome
Worst pain score during the first 48 hours after surgery
Time frame: 48 hours after end of surgery
Pain score on Verbal Numeric Rating Scale (VNRS) from 0 to 10, where 0 represents no pain at all and 10 represents worst pain imaginable.
11 secondary outcomes
Rebound pain
Time frame: From end of surgery until nerve block resolution, normally within the first 48 hours after surgery.
Pain score at different points of time after surgery
Time frame: From baseline, end of surgery, until 6 weeks after surgery.
Duration of moderate and strong pain
Time frame: From baseline, end of surgery, until first time patient reports VNRS below 7 and/or 4, normally within the first 48 hours.
Average and worst pain experience after surgery at different points of time
Time frame: From baseline, end of surgery, until 7 days after surgery.
Long-lasting pain
Time frame: From baseline, end of surgery, until 6 weeks after surgery.
Analgesic consumption after surgery
Time frame: From baseline, end of surgery, until 6 weeks after surgery.
Duration of motoric and sensoric nerve block
Time frame: From intervention, peripheral nerve block (needle out), until motoric and sensory resolution of nerve block, normally within the first 48 hours after intervention.
Life quality
Time frame: From baseline, end of surgery, until 6 weeks after surgery
Quality of long-term pain
Time frame: 6 weeks after baseline, intervention and surgery.
Patient satisfaction
Time frame: From enrollment until 6 weeks after surgery
Block success rate
Time frame: From intervention, when nerve block is performed, until 2 hours after surgery.
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 20 Apr 2026.
- Individual participant dataSharing planned: Yes. All individual participant data collected during the trial, after deidentification, will be available in Norwegian at a request. In addition, the Study Protocol is a public document from application moment. Researchers who provide a methodologically sound proposal will receive access to the deidentified individual pariticipant data, to achieve aims in the approved proposal. The data will be available immediately following publication and ending 5 years following article publication. Proposals should be directed to anette.aasen@medicin.uio.no.
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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.
Anette Aasen, MD, Anesthesiologist principal investigator
University of Oslo and Oslo University 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 concentration low and Ropivacaine concentration high in people with Radius Fracture Distal and Rebound Pain, run by Oslo University Hospital at 1 site in Norway.
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 9 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 20 Apr 2026. 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 Norway. 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?
Worst pain score during the first 48 hours after surgery (time frame: 48 hours after end of surgery). 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 20 Apr 2026.