PainNCT02412657
Intravenous Dexamethasone to Increase the Analgesic Duration of Interscalene Block
A study testing Dexamethasone and Normal Saline in people with Pain, run by Maisonneuve-Rosemont Hospital at 3 sites in Canada.
Trial summary
Interscalene brachial plexus block provides excellent but time limited analgesia. Intravenous dexamethasone increases the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder arthroscopic surgery. We want to evaluate the effect of two different doses (dexamethasone 10 mg i.v. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- Dexamethasone and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 3 sitesCanada
- Study dates
- Sep 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Elective shoulder arthroscopy under ropivacaine single-shot interscalene brachial plexus block anesthesia (rotator cuff repair and shoulder decompression)
- ASA I-III
- Age 18-80 years old
Who cannot join
- Any contraindication to interscalene brachial plexus block anesthesia
- Interscalene brachial plexus block failure
- Known local anesthetics allergy
- Dexamethasone allergy or intolerance
- Any contraindication to acetaminophen
- Any contraindication to morphine or hydromorphone
Show all 15Show fewer
- Brachial plexus neuropathies
- Chronic pain syndrome other than shoulder pain
- Routine use of opioid medication
- Routine use of systemic corticosteroid
- Pregnancy
- Weight below 50 kilograms
- Incapability to understand a numeric verbal pain scale
- Incapability to consent
- Patient refusal
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Hopital Pierre-Boucher
Longueuil, Quebec, J4M 2A5
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 4M5
Hopital Hotel-Dieu de Sorel
Sorel-Tracy, Quebec, J3P 1N5
About this study
Official title: Impact of Two Doses of Intravenous Dexamethasone on the Analgesic Duration of a Single-shot Interscalene Block With Ropivacaine for Shoulder Arthroscopy; a Prospective, Randomized, Placebo-controlled Study
Interscalene brachial plexus block provides excellent but time limited analgesia. Intravenous dexamethasone increases the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder arthroscopic surgery. We want to evaluate the effect of two different doses (dexamethasone 10 mg i.v. vs 4 mg i.v. vs placebo) on the analgesic duration of a single-shot inter scalene block. Our study hypothesis is that dexamethasone 4 mg i.v. is equivalent to dexamethasone10 mg i.v. in prolonging the analgesic duration of a single-shot interscalene block with ropivacaine.
Read the detailed description
75 patients will be randomly assigned to three groups:
- D10: dexamethasone 10 mg I.V. diluted in normal saline 20cc, immediately after inter scalene block
- D4: dexamethasone 4 mg I.V. diluted in normal saline 20cc, immediately after inter scalene block
- C: control: Normal saline 20cc I.V., immediately after inter scalene block. These patient will be recruited from 3 hospitals, with two surgeons performing the surgeries.
All patients will have their surgery under regional anesthesia only provided by the inter scalene plexus block, with ropivacaine 0.5% 20cc.
In the postoperative period, patients will be given analgesic medication on an as needed basis. They will be instructed to take the first analgesic medication once postoperative shoulder pain has reached >3/10. They will note the time and day at which this outcome occurs.
- Conditions
- Pain
- Being tested
- Dexamethasone, Normal Saline
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called decadron
After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v.
Normal SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone 10 mg intravenous | Experimental | Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block Receives: Drug: Dexamethasone |
| Dexamethasone 4 mg intravenous | Experimental | Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block Receives: Drug: Dexamethasone |
| Normal Saline 20 mL intravenous | Placebo comparator | Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Analgesia
Defined as the time between the performance of the block and the first analgesic request
Measured: 48 hours after surgery
Secondary outcomes (4)
Pain Scores
On a 11-points Verbal Numeric Scale 0-10 (0= no pain, 10= worst conceivable pain)
Measured: every 6 hours during the first 48 hours after surgery
Residual Motor Block
Scale of 0-2 (0:inability to move fingers, 1: fingers able to move, with diminished strength compared to non operated side, 2: No motor weakness of the fingers)
Measured: 24 hours and 48 hours
Sleep Disturbance
Sleep disturbance scale 0-10 (0: no sleep disturbance from pain, 10: worst conceivable sleep disruption from pain)
Measured: 24 hours and 48 hours
Patients Overall Satisfaction
categorical data (1: very satisfied, would recommend this analgesia protocol to others, 0: not satisfied, would not recommend this analgesia protocol to others
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startSep 2014
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veronique Brulotte, Maisonneuve-Rosemont Hospital
- Investigators
- Veronique Brulotte, MD MSc FRCPC, Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412657
- Sponsor's protocol ID
- dexaISB
- Status last verified
- Aug 2018
- First submitted
- 12 Mar 2015
- Last updated
- 13 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Chalifoux F, Colin F, St-Pierre P, Godin N, Brulotte V. Low dose intravenous dexamethasone (4 mg and 10 mg) significantly prolongs the analgesic duration of single-shot interscalene block after arthroscopic shoulder surgery: a prospective randomized placebo-controlled study. Can J Anaesth. 2017 Mar;64(3):280-289. doi: 10.1007/s12630-016-0796-6. Epub 2017 Jan 3.
PubMed 28050801
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Two Doses of Intravenous Dexamethasone on the Analgesic Duration of a Single-shot Interscalene Block With Ropivacaine for Shoulder Arthroscopy; a Prospective, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02412657
- Acronym / sponsor ID
- dexaISB
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 9 Apr 2015 (estimated)
- Results
- Posted 12 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interscalene brachial plexus block provides excellent but time limited analgesia. Intravenous dexamethasone increases the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder arthroscopic surgery. We want to evaluate the effect of two different doses (dexamethasone 10 mg i.v. vs 4 mg i.v. vs placebo) on the analgesic duration of a single-shot inter scalene block. Our study hypothesis is that dexamethasone 4 mg i.v. is equivalent to dexamethasone10 mg i.v. in prolonging the analgesic duration of a single-shot interscalene block with ropivacaine.
Detailed description
75 patients will be randomly assigned to three groups:
- D10: dexamethasone 10 mg I.V. diluted in normal saline 20cc, immediately after inter scalene block
- D4: dexamethasone 4 mg I.V. diluted in normal saline 20cc, immediately after inter scalene block
- C: control: Normal saline 20cc I.V., immediately after inter scalene block. These patient will be recruited from 3 hospitals, with two surgeons performing the surgeries.
All patients will have their surgery under regional anesthesia only provided by the inter scalene plexus block, with ropivacaine 0.5% 20cc.
In the postoperative period, patients will be given analgesic medication on an as needed basis. They will be instructed to take the first analgesic medication once postoperative shoulder pain has reached >3/10. They will note the time and day at which this outcome occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone 10 mg intravenous | Experimental | Drug: DexamethasoneDexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block |
| Dexamethasone 4 mg intravenous | Experimental | Drug: DexamethasoneDexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block |
| Normal Saline 20 mL intravenous | Placebo comparator | Drug: Normal SalineNormal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective shoulder arthroscopy under ropivacaine single-shot interscalene brachial plexus block anesthesia (rotator cuff repair and shoulder decompression)
- ASA I-III
- Age 18-80 years old
Key exclusion criteria (15 listed)
- Any contraindication to interscalene brachial plexus block anesthesia
- Interscalene brachial plexus block failure
- Known local anesthetics allergy
- Dexamethasone allergy or intolerance
- Any contraindication to acetaminophen
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: decadronAfter the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v. | Drug | Dexamethasone 10 mg intravenous, Dexamethasone 4 mg intravenous |
| Normal Saline | Drug | Normal Saline 20 mL intravenous |
Primary outcome
Duration of Analgesia
Time frame: 48 hours after surgery
Defined as the time between the performance of the block and the first analgesic request
4 secondary outcomes
Pain Scores
Time frame: every 6 hours during the first 48 hours after surgery
Residual Motor Block
Time frame: 24 hours and 48 hours
Sleep Disturbance
Time frame: 24 hours and 48 hours
Patients Overall Satisfaction
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28050801Chalifoux F, Colin F, St-Pierre P, Godin N, Brulotte V. Low dose intravenous dexamethasone (4 mg and 10 mg) significantly prolongs the analgesic duration of single-shot interscalene block after arthroscopic shoulder surgery: a prospective randomized placebo-controlled study. Can J Anaesth. 2017 Mar;64(3):280-289. doi: 10.1007/s12630-016-0796-6. Epub 2017 Jan 3.
- Individual participant dataSharing planned: Yes
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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.
Veronique Brulotte, MD MSc FRCPC principal investigator
Maisonneuve-Rosemont Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and Normal Saline in people with Pain, run by Maisonneuve-Rosemont Hospital at 3 sites in Canada.
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 3 inclusion and 15 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 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: 48 hours after surgery). 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 NCT02412657, 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 13 Sep 2018.