Postoperative PainPhase 4NCT02818491
Dexamethasone as an Adjuvant to Ropivacaine for the Interscalene Brachial Plexus Block
A Phase 4 study testing Dexamethasone 1 mg, Dexamethasone 2 mg and Dexamethasone 3 mg in people with Postoperative Pain, run by Centre Hospitalier Universitaire Vaudois at 1 site in Belgium.
Trial summary
Shoulder surgery is associated with moderate to severe postoperative pain. Interscalene brachial plexus block is considered by many as the gold standard for treating postoperative pain and consists of injecting local anaesthetics close to the nerves of the brachial plexus in the neck. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dexamethasone 1 mg, Dexamethasone 2 mg and Dexamethasone 3 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2017to 1 Nov 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for elective shoulder arthroscopy
- duration of surgery less than 4 hours
Who cannot join
- allergy to local anaesthetics
- history of neck surgery
- history of neck radiotherapy
- severe respiratory disease
- diabetic patient
- chronic pain condition
Show all 9Show fewer
- pregnancy
- patient suffering from cancer
- patient with addicted disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexamethasone as an Adjuvant to Ropivacaine for the Interscalene Brachial Plexus Block: a Dose-finding Study
Shoulder surgery is associated with moderate to severe postoperative pain. Interscalene brachial plexus block is considered by many as the gold standard for treating postoperative pain and consists of injecting local anaesthetics close to the nerves of the brachial plexus in the neck. Duration of analgesia is between eight to twelve hours depending on the type of administered drugs. Dexamethasone 4 mg is a steroid routinely injected intravenously in anaesthesia for the prophylaxis of postoperative nausea and vomiting. Recently, different trials have demonstrated that combining 4 to 8 mg of dexamethasone with local anaesthetics for a perineural injection may prolong the duration of analgesia up to 24 hours. In a meta-analysis including 29 trials and 1695 patients, investigators have recently demonstrated through a meta-regression that a dose of 4 mg is sufficient and represents a ceiling dose, without neurological complications. The objective of this multicenter randomised controlled double-blinded trial is to determine the optimal dose of perineural dexamethasone. For that purpose, investigators will include a total of 150 patients divided in 5 groups: local anaesthetics with placebo, or with dexamethasone 1, 2, 3 and 4 mg.
- Conditions
- Postoperative Pain
- Being tested
- Placebo, Dexamethasone 1 mg, Dexamethasone 2 mg, Dexamethasone 3 mg, Dexamethasone 4 mg
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Normal saline 0.9% in 2 mls
Dexamethasone 1 mgDrug
Dexamethasone 1 mg in 2 mls
Dexamethasone 2 mgDrug
Dexamethasone 2 mg in 2 mls
Dexamethasone 3 mgDrug
Dexamethasone 3 mg in 2 mls
Dexamethasone 4 mgDrug
Dexamethasone 4 mg in 2 mls
Ropivacaine 0.5%Drug
Ropivacaine 0.5% 20 mls
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Patients will receive ropivacaine 0.5% 20 mls with normal saline 0.9% 2 mls Receives: Drug: Placebo; Drug: Ropivacaine 0.5% |
| Dex 1 | Active comparator | Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 1 mg in 2 mls Receives: Drug: Dexamethasone 1 mg; Drug: Ropivacaine 0.5% |
| Dex 2 | Active comparator | Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 2 mg in 2 mls Receives: Drug: Dexamethasone 2 mg; Drug: Ropivacaine 0.5% |
| Dex 3 | Active comparator | Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 3 mg in 2 mls Receives: Drug: Dexamethasone 3 mg; Drug: Ropivacaine 0.5% |
| Dex 4 | Active comparator | Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 4 mg in 2 mls Receives: Drug: Dexamethasone 4 mg; Drug: Ropivacaine 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia
Measured: 24hour
Secondary outcomes (17)
Duration of motor block
Measured: 24hour
Onset time of action of sensory block
Measured: 1hour
Onset time of action of motor block
Measured: 1hour
Equivalent morphine consumption in postanesthetic care unit
Measured: 4hour
Equivalent morphine consumption on postoperative day 1
Measured: 24hour
Pain scores at rest in postanesthetic care unit (visual analogue scale, 0-10)
Measured: 4hour
Pain scores on movement in postanesthetic care unit (visual analogue scale, 0-10)
Measured: 4hour
Pain scores at rest on postoperative day 1 (visual analogue scale, 0-10)
Measured: 24hour
Pain scores on movement on postoperative day 1 (visual analogue scale, 0-10)
Measured: 24hour
Rate of postoperative nausea and vomiting (PONV)
Presence of PONV (YES/NO)
Measured: 24hour
Rate of pruritus
Presence of pruritus (YES/NO)
Measured: 24hour
Satisfaction score on postoperative day 1 (visual analogue scale, 0-10)
Measured: 24hour
Glycemia in postanesthetic care unit (mmol/l)
Measured: 4hour
Rate of infection
Presence of infection (YES/NO)
Measured: 24hour
Rate of infection
Presence of infection (YES/NO)
Measured: 7 days
Rate of paresthesia
Presence of paresthesia (YES/NO)
Measured: 7 days
Rate of muscle weakness
Presence of muscle weakness (YES/NO)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study start1 Nov 2017
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
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.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Albrecht, Centre Hospitalier Universitaire Vaudois
- Investigators
- Eric Albrecht, MD, Study director, Centre Hospitalier Universitaire VaudoisMatthias Matthias, MD, Principal investigator, AZ Groeninge Hospital, Pres. Kennedylaan 4, 8500 Kortrijk, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818491
- Sponsor's protocol ID
- CER 217/15
- Status last verified
- Jan 2020
- First submitted
- 23 Jun 2016
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone as an Adjuvant to Ropivacaine for the Interscalene Brachial Plexus Block: a Dose-finding Study
- ClinicalTrials.gov ID
- NCT02818491
- Acronym / sponsor ID
- CER 217/15
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 29 Jun 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.
Shoulder surgery is associated with moderate to severe postoperative pain. Interscalene brachial plexus block is considered by many as the gold standard for treating postoperative pain and consists of injecting local anaesthetics close to the nerves of the brachial plexus in the neck. Duration of analgesia is between eight to twelve hours depending on the type of administered drugs. Dexamethasone 4 mg is a steroid routinely injected intravenously in anaesthesia for the prophylaxis of postoperative nausea and vomiting. Recently, different trials have demonstrated that combining 4 to 8 mg of dexamethasone with local anaesthetics for a perineural injection may prolong the duration of analgesia up to 24 hours. In a meta-analysis including 29 trials and 1695 patients, investigators have recently demonstrated through a meta-regression that a dose of 4 mg is sufficient and represents a ceiling dose, without neurological complications. The objective of this multicenter randomised controlled double-blinded trial is to determine the optimal dose of perineural dexamethasone. For that purpose, investigators will include a total of 150 patients divided in 5 groups: local anaesthetics with placebo, or with dexamethasone 1, 2, 3 and 4 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Placebo, Drug: Ropivacaine 0.5%Patients will receive ropivacaine 0.5% 20 mls with normal saline 0.9% 2 mls |
| Dex 1 | Active comparator | Drug: Dexamethasone 1 mg, Drug: Ropivacaine 0.5%Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 1 mg in 2 mls |
| Dex 2 | Active comparator | Drug: Dexamethasone 2 mg, Drug: Ropivacaine 0.5%Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 2 mg in 2 mls |
| Dex 3 | Active comparator | Drug: Dexamethasone 3 mg, Drug: Ropivacaine 0.5%Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 3 mg in 2 mls |
| Dex 4 | Active comparator | Drug: Dexamethasone 4 mg, Drug: Ropivacaine 0.5%Patients will receive ropivacaine 0.5% 20 mls with dexamethasone 4 mg in 2 mls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients scheduled for elective shoulder arthroscopy
- duration of surgery less than 4 hours
Key exclusion criteria (9 listed)
- allergy to local anaesthetics
- history of neck surgery
- history of neck radiotherapy
- severe respiratory disease
- diabetic patient
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 |
|---|---|---|
| PlaceboNormal saline 0.9% in 2 mls | Drug | Control group |
| Dexamethasone 1 mgDexamethasone 1 mg in 2 mls | Drug | Dex 1 |
| Dexamethasone 2 mgDexamethasone 2 mg in 2 mls | Drug | Dex 2 |
| Dexamethasone 3 mgDexamethasone 3 mg in 2 mls | Drug | Dex 3 |
| Dexamethasone 4 mgDexamethasone 4 mg in 2 mls | Drug | Dex 4 |
| Ropivacaine 0.5%Ropivacaine 0.5% 20 mls | Drug | Control group, Dex 1, Dex 2, Dex 3, Dex 4 |
Primary outcome
Duration of analgesia
Time frame: 24hour
17 secondary outcomes
Duration of motor block
Time frame: 24hour
Onset time of action of sensory block
Time frame: 1hour
Onset time of action of motor block
Time frame: 1hour
Equivalent morphine consumption in postanesthetic care unit
Time frame: 4hour
Equivalent morphine consumption on postoperative day 1
Time frame: 24hour
Pain scores at rest in postanesthetic care unit (visual analogue scale, 0-10)
Time frame: 4hour
Pain scores on movement in postanesthetic care unit (visual analogue scale, 0-10)
Time frame: 4hour
Pain scores at rest on postoperative day 1 (visual analogue scale, 0-10)
Time frame: 24hour
Pain scores on movement on postoperative day 1 (visual analogue scale, 0-10)
Time frame: 24hour
Rate of postoperative nausea and vomiting (PONV)
Time frame: 24hour
Rate of pruritus
Time frame: 24hour
Satisfaction score on postoperative day 1 (visual analogue scale, 0-10)
Time frame: 24hour
Glycemia in postanesthetic care unit (mmol/l)
Time frame: 4hour
Rate of infection
Time frame: 24hour
Rate of infection
Time frame: 7 days
Rate of paresthesia
Time frame: 7 days
Rate of muscle weakness
Time frame: 7 days
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 7 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
Eric Albrecht, MD study director
Centre Hospitalier Universitaire Vaudois
Matthias Matthias, MD principal investigator
AZ Groeninge Hospital, Pres. Kennedylaan 4, 8500 Kortrijk, Belgium
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 Dexamethasone 1 mg, Dexamethasone 2 mg and Dexamethasone 3 mg in people with Postoperative Pain, run by Centre Hospitalier Universitaire Vaudois at 1 site in Belgium.
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 9 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 7 Jan 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 Belgium. 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 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 analgesia (time frame: 24hour). 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 7 Jan 2020.