Brachial Plexus BlockPhase 3NCT03011905
Rebound Pain After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block
A Phase 3 study testing Dexamethasone, Paracetamol and EtoriCoxib in people with Brachial Plexus Block and Pain, Postoperative, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Many patients have strong pain at brachial plexus block resolution after operations for distal radius fractures with a volar plate. This study investigates if a single dose of dexamethasone in addition to a standard pain regime have an effect on postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Brachial Plexus Block, Pain, Postoperative
- What is being tested?
- Dexamethasone, Paracetamol and EtoriCoxib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2017to 5 Apr 2020
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Distal radius fracture planned for operation with a volar plate
- 0-20 days after trauma
- AO classification A, B, and C
- ASA 1 and 2
- Age 18-65
- BMI 18-35
- Able to communicate in Norwegian
Who cannot join
- Chronic pain
- Other injuries
- Pregnancy
- Known allergic reactions to medicines used in the study
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo Universitetssykehus, Ullevaal, dept of anaesthesiology, legevakten
Oslo, 0540
About this study
Official title: Rebound Pain at Block Resolution After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block
Many patients have strong pain at brachial plexus block resolution after operations for distal radius fractures with a volar plate. This study investigates if a single dose of dexamethasone in addition to a standard pain regime have an effect on postoperative pain. The primary endpoint is difference in the highest pain score first 24 hours after surgery. The investigators will also look at pain scores and analgesics consumption first few hours after surgery and at different times up to 2 years after surgery.
Read the detailed description
This double-blind randomized clinical study evaluates pain, analgesic consumption and different measurements of patients satisfaction after operations for distal radius fractures with a volar plate in the day-care surgery unit. All patients will receive paracetamol and etoricoxib as oral premedication. Patients will be operated in infraclavicular brachial plexus block with ropivacaine 7,5 mg/ml. Patients in the intervention group will receive a single dose of 16 mg dexamethasone during the operation. Patients in the control group will receive NaCl iv.
After surgery, iv and oral rapid release oxycodone as needed while in hospital. After discharge (after 2-4 hours), etoricoxib for 2 days, controlled release oxycodone, total of 3 doses. Rapid release oxycodone as needed.
Patients will be followed up by telephone interviews at different times after surgery.
- Conditions
- Brachial Plexus Block, Pain, Postoperative
- Being tested
- Dexamethasone, NaCl (Control), Paracetamol, EtoriCoxib, Oxycodone
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called DexaGalen
4 ml DexaGalen 4 mg/ml
NaCl (Control)Drug
Also called NaCl
4 ml NaCl 9 mg/ml
ParacetamolDrug
Premedication and as needed after operation
EtoriCoxibDrug
Also called Arcoxia
Premedication and first 2 postoperative days.
OxycodoneDrug
Also called OxyContin, OxyNorm
Total of 3 doses of OxyContin postoperatively. OxyNorm as needed.
RopivacaineDrug
In brachial plexus block
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Single dose of dexamethasone (Dexagalen) 16 mg iv during operation. Receives: Drug: Dexamethasone; Drug: Paracetamol; Drug: EtoriCoxib; Drug: Oxycodone; Drug: Ropivacaine |
| Control | Placebo comparator | Single dose of NaCl, 4 ml, iv during operation. Receives: Drug: NaCl (Control); Drug: Paracetamol; Drug: EtoriCoxib; Drug: Oxycodone; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between groups in highest pain scores first 24 hours after surgery
Measured: 24 hours
Secondary outcomes (13)
Differences in pain scores after 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours
Measured: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours
Differences in pain scores after 36 hours, 3 days, 7 days, 6 weeks
Measured: 36 hours, 3 days, 7 days, 6 weeks
Differences in pain scores after 6 months and 1 year
Measured: 6 months and 1 year
Differences in analgesic consumption
Measured: 1 hours, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours, 1 week, 6 weeks, 6 months, 1 year
Differences in block duration
Measured: 20 hours
Differences between groups in sedation postoperatively assessed with Likert scale
Likert scale
Measured: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Differences between groups in sleep quality assessed with Likert scale
Likert scale
Measured: 24 hours
Differences between groups in nausea postoperatively assessed with Likert scale
Likert scale
Measured: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Differences between groups in vomiting postoperatively assessed with Likert scale
Likert scale
Measured: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Differences between groups in itching postoperatively assessed with Likert scale
Likert scale
Measured: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Differences in time to first pain score under 4 after block resolution
Measured: 7 days
Differences in side effects
Measured: 1 year
Differences in Patient Rated Wrist/Hand Evaluation (PRWHE) scores after 6 weeks
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startJan 2017
- Primary completion5 Apr 2019
- Study completion5 Apr 2020
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 Brachial Plexus BlockStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 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, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011905
- Sponsor's protocol ID
- 2016/599/REK sør-øst C
- Status last verified
- Sep 2020
- First submitted
- 21 Dec 2016
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Holmberg A, Hassellund SS, Draegni T, Nordby A, Ottesen FS, Gulestol A, Raeder J. Analgesic effect of intravenous dexamethasone after volar plate surgery for distal radius fracture with brachial plexus block anaesthesia: a prospective, double-blind randomised clinical trial. Anaesthesia. 2020 Nov;75(11):1448-1460. doi: 10.1111/anae.15111. Epub 2020 May 30.
PubMed 32472958
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rebound Pain at Block Resolution After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT03011905
- Acronym / sponsor ID
- 2016/599/REK sør-øst C
- Conditions
- Brachial Plexus Block, Pain, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 5 Apr 2020 (actual)
- First posted
- 5 Jan 2017 (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.
Many patients have strong pain at brachial plexus block resolution after operations for distal radius fractures with a volar plate. This study investigates if a single dose of dexamethasone in addition to a standard pain regime have an effect on postoperative pain. The primary endpoint is difference in the highest pain score first 24 hours after surgery. The investigators will also look at pain scores and analgesics consumption first few hours after surgery and at different times up to 2 years after surgery.
Detailed description
This double-blind randomized clinical study evaluates pain, analgesic consumption and different measurements of patients satisfaction after operations for distal radius fractures with a volar plate in the day-care surgery unit. All patients will receive paracetamol and etoricoxib as oral premedication. Patients will be operated in infraclavicular brachial plexus block with ropivacaine 7,5 mg/ml. Patients in the intervention group will receive a single dose of 16 mg dexamethasone during the operation. Patients in the control group will receive NaCl iv.
After surgery, iv and oral rapid release oxycodone as needed while in hospital. After discharge (after 2-4 hours), etoricoxib for 2 days, controlled release oxycodone, total of 3 doses. Rapid release oxycodone as needed.
Patients will be followed up by telephone interviews at different times 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 |
|---|---|---|
| Dexamethasone | Experimental | Drug: Dexamethasone, Drug: Paracetamol, Drug: EtoriCoxib, Drug: Oxycodone, Drug: RopivacaineSingle dose of dexamethasone (Dexagalen) 16 mg iv during operation. |
| Control | Placebo comparator | Drug: NaCl (Control), Drug: Paracetamol, Drug: EtoriCoxib, Drug: Oxycodone, Drug: RopivacaineSingle dose of NaCl, 4 ml, iv during operation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Distal radius fracture planned for operation with a volar plate
- 0-20 days after trauma
- AO classification A, B, and C
- ASA 1 and 2
- Age 18-65
Key exclusion criteria (4 listed)
- Chronic pain
- Other injuries
- Pregnancy
- Known allergic reactions to medicines used in the study
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 |
|---|---|---|
| DexamethasoneAlso: DexaGalen4 ml DexaGalen 4 mg/ml | Drug | Dexamethasone |
| NaCl (Control)Also: NaCl4 ml NaCl 9 mg/ml | Drug | Control |
| ParacetamolPremedication and as needed after operation | Drug | Control, Dexamethasone |
| EtoriCoxibAlso: ArcoxiaPremedication and first 2 postoperative days. | Drug | Control, Dexamethasone |
| OxycodoneAlso: OxyContin, OxyNormTotal of 3 doses of OxyContin postoperatively. OxyNorm as needed. | Drug | Control, Dexamethasone |
| RopivacaineIn brachial plexus block | Drug | Control, Dexamethasone |
Primary outcome
Differences between groups in highest pain scores first 24 hours after surgery
Time frame: 24 hours
13 secondary outcomes
Differences in pain scores after 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours
Time frame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours
Differences in pain scores after 36 hours, 3 days, 7 days, 6 weeks
Time frame: 36 hours, 3 days, 7 days, 6 weeks
Differences in pain scores after 6 months and 1 year
Time frame: 6 months and 1 year
Differences in analgesic consumption
Time frame: 1 hours, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours, 1 week, 6 weeks, 6 months, 1 year
Differences in block duration
Time frame: 20 hours
Differences between groups in sedation postoperatively assessed with Likert scale
Time frame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Differences between groups in sleep quality assessed with Likert scale
Time frame: 24 hours
Differences between groups in nausea postoperatively assessed with Likert scale
Time frame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Differences between groups in vomiting postoperatively assessed with Likert scale
Time frame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Differences between groups in itching postoperatively assessed with Likert scale
Time frame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
Differences in time to first pain score under 4 after block resolution
Time frame: 7 days
Differences in side effects
Time frame: 1 year
Differences in Patient Rated Wrist/Hand Evaluation (PRWHE) scores after 6 weeks
Time frame: 6 weeks
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 21 Sep 2020.
- Derived from this study: PubMed 32472958Holmberg A, Hassellund SS, Draegni T, Nordby A, Ottesen FS, Gulestol A, Raeder J. Analgesic effect of intravenous dexamethasone after volar plate surgery for distal radius fracture with brachial plexus block anaesthesia: a prospective, double-blind randomised clinical trial. Anaesthesia. 2020 Nov;75(11):1448-1460. doi: 10.1111/anae.15111. Epub 2020 May 30.
- 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.
Anne Holmberg, MD principal investigator
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 3 study testing Dexamethasone, Paracetamol and EtoriCoxib in people with Brachial Plexus Block and Pain, Postoperative, 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 7 inclusion and 4 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 21 Sep 2020. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Differences between groups in highest pain scores first 24 hours after surgery (time frame: 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 NCT03011905, 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 21 Sep 2020.