Radial FractureRADARNCT03749174
Radius Fracture Anesthesia and Rehabilitation (RADAR)
A study testing Long acting Supraclivicular block vs Short acting Supraclavicular block in people with Radial Fracture, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Distal fracture of the radial bone is the commonest fracture and is also connected to osteoporosis. Normally the operation is performed under neuroaxial blockade and sedation. When the blockade rapidly vanish many patients experience a rebound pain much severer that than the actual trauma pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Fracture
- What is being tested?
- Long acting Supraclivicular block vs Short acting Supraclavicular block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 3 Sep 2018to 20 Jun 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understands native language
- Cognitive intact
- Fracture types AO 23..A and AO 23.C.1
- Operated within 18 days from initial trauma
Who cannot join
- Not fulfilling inclusion criterias
- High energy trauma
- Ligament injury
Trial locations and contacts
1 site in 1 country.
About this study
Distal fracture of the radial bone is the commonest fracture and is also connected to osteoporosis. Normally the operation is performed under neuroaxial blockade and sedation. When the blockade rapidly vanish many patients experience a rebound pain much severer that than the actual trauma pain. If long acting local anesthetics are used this will occur during night time and many patients will go to the emergency room for pain treatment. Short acting local anesthetics may make it possible to treat patients pain in-house prior to leaving the hospital. In this study
Read the detailed description
This investigation is a joint study involving Occupational Therapist, Orthopedic surgeons and Anesthesiologist. Distal fracture of the radial bone is the commonest fracture, mainly in elder females with osteoporosis and also obesity. Normally 75% of patients are treated with plaster after fracture repositioning. The remaining 25% are operated upon. Routinely, the operation is performed under neuroaxial blockade and sedation. When the blockade rapidly vanish many patients experience a rebound pain much severer than the initial trauma pain. If long acting local anesthetics are used the blockade will be terminated during night and many patients will go to the Emergency room for pain treatment. Short acting local anesthetics may make it possible to treat patients pain in-house prior to hospital discharge and thus reduce severe rebound pain.
In this study patients with radial fractures are included and operated upon by a standard surgical operation with plate and screws. They will receive either 1) ultra sound guided supraclavicular block long-acting (n=30) local anesthetic , 2) ultra sound guided supraclavicular block short-acing (n=60) local anesthetics or 3) general anesthesia (n=30) to provide analgesia during the operational procedure. Patients given an ultra sound guided blockade with short-acting local anesthetic (n=60) are further sub-divided into receiving either postoperative plaster/cast (n=30) or an orthosis/brace (n=30).
Patients pain will be measured by Numeric Rating scale (0 = no pain and 10 worst possible pain) during the first 7 postoperative days. The opioid consumption will be noted by personal contact intermittently by telephone and by a pain diary until day 7. Both parametric and none-parametric analysis will be conducted.
Quality of recovery will be assessed by Quality of Recovery Scale 15 at 5 occasions. Adverse effects and unplanned health care contacts will also be gathered.
After 3 days the Occupational Therapist will control the patients followed by investigations at 2, 6 12 and 52 weeks. The patients will be graded the Patient rated Wrist Evaluation (PRWE) and Michigan Outcomes Questionnaire (MHQ) Edema will be measured and strength will be measured by Jamar dynamometer, Finally, Sense of coherence will be measured by KASAM-13
- Conditions
- Radial Fracture
- Being tested
- Long acting Supraclivicular block vs Short acting Supraclavicular block
- Keywords
- Radial fracture, Anesthetic, Plaster, Cast, Orthosis, Brace, Postoperative pain, Quality of Recovery
- Medical subject headings
- Radius Fractures, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long acting Supraclivicular block vs Short acting Supraclavicular blockProcedure or surgery
Also called Long acting anesthetic block/plaster, Short acting anesthetic block/plaster, Short acting anesthetic block/orthosis, General Anesthesia and plaster
Patients are randomized to receive; long-acting Supraclavicular plexus block or short-acting Supraclavicular plexus block or general anesthesia
Sub group randomized to plaster/cast or orthosis/brace, both having short-acting block
| Study group | Role | What they receive |
|---|---|---|
| Long acting anesthetic block/plaster | Active comparator | Intervention 1: Blockade will be given supraclavicularly with Long acting local Anesthetic (n=30) combined with post operative plaster immobilization. Receives: Procedure: Long acting Supraclivicular block vs Short acting Supraclavicular block |
| Short acting anesthetic block/plaster | Active comparator | Intervention 2: Blockade will be given supraclavicularly with Short acting local anesthetic (n=30) combined with plaster immobilisation postoperatively Receives: Procedure: Long acting Supraclivicular block vs Short acting Supraclavicular block |
| Short acting anesthetic block/orthotic | Active comparator | Intervention 3: Blockade will be given supraclavicularly with Short acting local anesthetic (n=30) and combined with orthosis for postoperative immobilisation Receives: Procedure: Long acting Supraclivicular block vs Short acting Supraclavicular block |
| General Anesthesia and plaster | Active comparator | Intervention 4: General anesthesia wil be administered for surgical procedure combined with postoperative plaster immobilisation (n=30), Receives: Procedure: Long acting Supraclivicular block vs Short acting Supraclavicular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebound pain, difference in pain (NRS) at rest at 24-hours and further during the first three days after surgery between short acting block (mepivacaine) and long acting block (ropivacaine), with General Anesthesia being control group.
Postoperative pain measured by numeric pain rating scale (NRS), where 0 = no pain and 10 = worst possible pain.
Measured: 72 hours
Quality of Recovery; difference in sum median and its five domains of QoR-15 score at baseline, 24 hours, 72 hours and 7 days after surgery between the two groups cast and orthosis/brace. - Anesthesiology part 2
Quality of Recovery scale 15 assessment
Measured: 1st three postoperative days
Post surgery arm function - Occupational therapist
Influence of immobilization by plaster or orthosis/brace
Measured: 12 months
Secondary outcomes (7)
Post surgery opioid requirement - Anesthesiology part
daily opioid requirement mg dose
Measured: day 1 to 3 after surgery, including day 7 assessing immobilization (cast/brace)
Perioperative time events - Anesthesiology part
Perioperative time events; e.g. duration of surgery, anesthesia, Theatre time and recovery room stay
Measured: perioperatively
Postoperative Nausea and Vomiting - Anesthesiology part
Any experience of PONV
Measured: up to 72 hours post surgery
Unplanned health care contact - Anesthesiology part
any unplanned contact with health care, emergency department visit, phone calls, GP visits etc.
Measured: 1st postoperative week
Post surgery arm status 1 - Occupational therapist
Clinical evaluation of post surgery arm status by a physiotherapist including: oedema,
Measured: 12 months
Post surgery arm status 2 - Occupational therapist
Clinical evaluation of post surgery arm status by a physiotherapist including: grip strength
Measured: 12 months
Post surgery arm status 3 - Occupational therapist
Clinical evaluation of post surgery arm status by a physiotherapist including sense of coherence.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start3 Sep 2018
- Primary completion1 Jul 2020
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Radial FractureStudies of the same condition, open and under way.
- More trials run by Sahlgrenska 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Patients are subdivided into 3 groups where one group is further subdivided into 2 groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bengt Nellgård, Sahlgrenska University Hospital
- Investigators
- Bengt Nellgard, MD PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749174
- Sponsor's protocol ID
- RADAR
- Acronym
- RADAR
- Status last verified
- Oct 2022
- First submitted
- 22 Aug 2018
- Last updated
- 27 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Galos DK, Taormina DP, Crespo A, Ding DY, Sapienza A, Jain S, Tejwani NC. Does Brachial Plexus Blockade Result in Improved Pain Scores After Distal Radius Fracture Fixation? A Randomized Trial. Clin Orthop Relat Res. 2016 May;474(5):1247-54. doi: 10.1007/s11999-016-4735-1. Epub 2016 Feb 11.
PubMed 26869374Blomstrand J, Sellbrant I, Nellgard B, Karlsson J, Fagevik Olsen M, Kjellby Wendt G. Removable brace is as good as plaster cast after surgically treated distal radius fracture - a randomised controlled study of pain and wrist function. J Orthop Surg Res. 2025 Jul 21;20(1):691. doi: 10.1186/s13018-025-06097-0.
PubMed 40691623Sellbrant I, Karlsson J, Jakobsson JG, Nellgard B. Supraclavicular block with Mepivacaine vs Ropivacaine, their impact on postoperative pain: a prospective randomised study. BMC Anesthesiol. 2021 Nov 9;21(1):273. doi: 10.1186/s12871-021-01499-z.
PubMed 34753423
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radius Fracture Anesthesia and Rehabilitation (RADAR)
- ClinicalTrials.gov ID
- NCT03749174
- Acronym / sponsor ID
- RADAR / RADAR
- Conditions
- Radial Fracture
- Keywords
- Radial fracture, Anesthetic, Plaster, Cast, Orthosis, Brace, Postoperative pain, Quality of Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 21 Nov 2018 (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.
Distal fracture of the radial bone is the commonest fracture and is also connected to osteoporosis. Normally the operation is performed under neuroaxial blockade and sedation. When the blockade rapidly vanish many patients experience a rebound pain much severer that than the actual trauma pain. If long acting local anesthetics are used this will occur during night time and many patients will go to the emergency room for pain treatment. Short acting local anesthetics may make it possible to treat patients pain in-house prior to leaving the hospital. In this study
Detailed description
This investigation is a joint study involving Occupational Therapist, Orthopedic surgeons and Anesthesiologist. Distal fracture of the radial bone is the commonest fracture, mainly in elder females with osteoporosis and also obesity. Normally 75% of patients are treated with plaster after fracture repositioning. The remaining 25% are operated upon. Routinely, the operation is performed under neuroaxial blockade and sedation. When the blockade rapidly vanish many patients experience a rebound pain much severer than the initial trauma pain. If long acting local anesthetics are used the blockade will be terminated during night and many patients will go to the Emergency room for pain treatment. Short acting local anesthetics may make it possible to treat patients pain in-house prior to hospital discharge and thus reduce severe rebound pain.
In this study patients with radial fractures are included and operated upon by a standard surgical operation with plate and screws. They will receive either 1) ultra sound guided supraclavicular block long-acting (n=30) local anesthetic , 2) ultra sound guided supraclavicular block short-acing (n=60) local anesthetics or 3) general anesthesia (n=30) to provide analgesia during the operational procedure. Patients given an ultra sound guided blockade with short-acting local anesthetic (n=60) are further sub-divided into receiving either postoperative plaster/cast (n=30) or an orthosis/brace (n=30).
Patients pain will be measured by Numeric Rating scale (0 = no pain and 10 worst possible pain) during the first 7 postoperative days. The opioid consumption will be noted by personal contact intermittently by telephone and by a pain diary until day 7. Both parametric and none-parametric analysis will be conducted.
Quality of recovery will be assessed by Quality of Recovery Scale 15 at 5 occasions. Adverse effects and unplanned health care contacts will also be gathered.
After 3 days the Occupational Therapist will control the patients followed by investigations at 2, 6 12 and 52 weeks. The patients will be graded the Patient rated Wrist Evaluation (PRWE) and Michigan Outcomes Questionnaire (MHQ) Edema will be measured and strength will be measured by Jamar dynamometer, Finally, Sense of coherence will be measured by KASAM-13
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Patients are subdivided into 3 groups where one group is further subdivided into 2 groups
| Arm | Type | Receives |
|---|---|---|
| Long acting anesthetic block/plaster | Active comparator | Procedure: Long acting Supraclivicular block vs Short acting Supraclavicular blockIntervention 1: Blockade will be given supraclavicularly with Long acting local Anesthetic (n=30) combined with post operative plaster immobilization. |
| Short acting anesthetic block/plaster | Active comparator | Procedure: Long acting Supraclivicular block vs Short acting Supraclavicular blockIntervention 2: Blockade will be given supraclavicularly with Short acting local anesthetic (n=30) combined with plaster immobilisation postoperatively |
| Short acting anesthetic block/orthotic | Active comparator | Procedure: Long acting Supraclivicular block vs Short acting Supraclavicular blockIntervention 3: Blockade will be given supraclavicularly with Short acting local anesthetic (n=30) and combined with orthosis for postoperative immobilisation |
| General Anesthesia and plaster | Active comparator | Procedure: Long acting Supraclivicular block vs Short acting Supraclavicular blockIntervention 4: General anesthesia wil be administered for surgical procedure combined with postoperative plaster immobilisation (n=30), |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Understands native language
- Cognitive intact
- Fracture types AO 23..A and AO 23.C.1
- Operated within 18 days from initial trauma
Key exclusion criteria (3 listed)
- Not fulfilling inclusion criterias
- High energy trauma
- Ligament injury
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 |
|---|---|---|
| Long acting Supraclivicular block vs Short acting Supraclavicular blockAlso: Long acting anesthetic block/plaster, Short acting anesthetic block/plaster, Short acting anesthetic block/orthosis, General Anesthesia and plasterPatients are randomized to receive; long-acting Supraclavicular plexus block or short-acting Supraclavicular plexus block or general anesthesia Sub group randomized to plaster/cast or orthosis/brace, both having short-acting block | Procedure or surgery | General Anesthesia and plaster, Long acting anesthetic block/plaster, Short acting anesthetic block/orthotic, Short acting anesthetic block/plaster |
Primary outcome
Rebound pain, difference in pain (NRS) at rest at 24-hours and further during the first three days after surgery between short acting block (mepivacaine) and long acting block (ropivacaine), with General Anesthesia being control group.
Time frame: 72 hours
Postoperative pain measured by numeric pain rating scale (NRS), where 0 = no pain and 10 = worst possible pain.
Quality of Recovery; difference in sum median and its five domains of QoR-15 score at baseline, 24 hours, 72 hours and 7 days after surgery between the two groups cast and orthosis/brace. - Anesthesiology part 2
Time frame: 1st three postoperative days
Quality of Recovery scale 15 assessment
Post surgery arm function - Occupational therapist
Time frame: 12 months
Influence of immobilization by plaster or orthosis/brace
7 secondary outcomes
Post surgery opioid requirement - Anesthesiology part
Time frame: day 1 to 3 after surgery, including day 7 assessing immobilization (cast/brace)
Perioperative time events - Anesthesiology part
Time frame: perioperatively
Postoperative Nausea and Vomiting - Anesthesiology part
Time frame: up to 72 hours post surgery
Unplanned health care contact - Anesthesiology part
Time frame: 1st postoperative week
Post surgery arm status 1 - Occupational therapist
Time frame: 12 months
Post surgery arm status 2 - Occupational therapist
Time frame: 12 months
Post surgery arm status 3 - Occupational therapist
Time frame: 12 months
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 27 Oct 2022.
- Background: PubMed 26869374Galos DK, Taormina DP, Crespo A, Ding DY, Sapienza A, Jain S, Tejwani NC. Does Brachial Plexus Blockade Result in Improved Pain Scores After Distal Radius Fracture Fixation? A Randomized Trial. Clin Orthop Relat Res. 2016 May;474(5):1247-54. doi: 10.1007/s11999-016-4735-1. Epub 2016 Feb 11.
- Derived from this study: PubMed 40691623Blomstrand J, Sellbrant I, Nellgard B, Karlsson J, Fagevik Olsen M, Kjellby Wendt G. Removable brace is as good as plaster cast after surgically treated distal radius fracture - a randomised controlled study of pain and wrist function. J Orthop Surg Res. 2025 Jul 21;20(1):691. doi: 10.1186/s13018-025-06097-0.
- Derived from this study: PubMed 34753423Sellbrant I, Karlsson J, Jakobsson JG, Nellgard B. Supraclavicular block with Mepivacaine vs Ropivacaine, their impact on postoperative pain: a prospective randomised study. BMC Anesthesiol. 2021 Nov 9;21(1):273. doi: 10.1186/s12871-021-01499-z.
- Individual participant dataSharing planned: 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.
Bengt Nellgard, MD PhD principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long acting Supraclivicular block vs Short acting Supraclavicular block in people with Radial Fracture, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 4 inclusion and 3 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 27 Oct 2022. 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 Sweden. 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.
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?
Rebound pain, difference in pain (NRS) at rest at 24-hours and further during the first three days after surgery between short acting block (mepivacaine) and long acting block (ropivacaine), with General Anesthesia being control group. (time frame: 72 hours). The study lists 3 primary outcomes in all. 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 NCT03749174, which also lists 3 linked publications.
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 27 Oct 2022.