PainNCT01740141
Plexus Brachialis Block. Better to do by Start Than by End of Surgery?
A study testing Plexus brachialis block in people with Pain, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The aim of the study is to find out if the timing of brachial plexus block, before or after surgery, has an impact of the extent of acute postoperative surgical pain or the incidence and severity of long-lasting (chronic) pain after surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain
- What is being tested?
- Plexus brachialis block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2012to Apr 2016
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radial fracture
- ASA 1 and 2
- Able to communicate in norwegian
- Suitable for surgery in general anaesthesia and brachial plexus block
Who cannot join
- Pregnancy
- Chronic pain
- BMI over 35
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo Universitetssykehus, Ullevaal, dept of anaesthesiology, legevakten
Oslo, Oslo, 0540
About this study
The aim of the study is to find out if the timing of brachial plexus block, before or after surgery, has an impact of the extent of acute postoperative surgical pain or the incidence and severity of long-lasting (chronic) pain after surgery.
This is a prospective, randomized, double blind study in patients with radial fractures undergoing surgery with volar plate. The patients will be followed up for 6 months after surgery.
- Conditions
- Pain
- Being tested
- Plexus brachialis block
- Keywords
- Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plexus brachialis blockProcedure or surgery
Also called LSIB. Ropivacain 7,5 mg/ml, 0,5 ml/kg
| Study group | Role | What they receive |
|---|---|---|
| Plexus before surgery | Other | Plexus brachialis before surgery Receives: Procedure: Plexus brachialis block |
| Plexus after surgery | Other | Plexus brachialis performed after surgery Receives: Procedure: Plexus brachialis block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
NAS
Measured: postoperative to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Holmberg, Oslo University Hospital
- Investigators
- Anne Holmberg, MD, Principal investigator, MD Ullevaal sykehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740141
- Sponsor's protocol ID
- 2011/476a
- Status last verified
- Apr 2016
- First submitted
- 22 Nov 2012
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plexus Brachialis Block. Better to do by Start Than by End of Surgery?
- ClinicalTrials.gov ID
- NCT01740141
- Acronym / sponsor ID
- 2011/476a
- Conditions
- Pain
- Keywords
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 4 Dec 2012 (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 of the study is to find out if the timing of brachial plexus block, before or after surgery, has an impact of the extent of acute postoperative surgical pain or the incidence and severity of long-lasting (chronic) pain after surgery.
This is a prospective, randomized, double blind study in patients with radial fractures undergoing surgery with volar plate. The patients will be followed up for 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plexus before surgery | Other | Procedure: Plexus brachialis blockPlexus brachialis before surgery |
| Plexus after surgery | Other | Procedure: Plexus brachialis blockPlexus brachialis performed after surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Radial fracture
- ASA 1 and 2
- Able to communicate in norwegian
- Suitable for surgery in general anaesthesia and brachial plexus block
Key exclusion criteria (3 listed)
- Pregnancy
- Chronic pain
- BMI over 35
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 |
|---|---|---|
| Plexus brachialis blockAlso: LSIB. Ropivacain 7,5 mg/ml, 0,5 ml/kg | Procedure or surgery | Plexus after surgery, Plexus before surgery |
Primary outcome
Pain
Time frame: postoperative to 6 months
NAS
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 6 Apr 2016.
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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.
Anne Holmberg, MD principal investigator
MD Ullevaal sykehus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plexus brachialis block in people with 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 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 6 Apr 2016. 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.
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?
Pain (time frame: postoperative to 6 months). 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 6 Apr 2016.