Shoulder SurgeryPhase 4ISB-DexNCT02322242
The Effects of Dexamethasone on Low Dose Interscalene Brachial Plexus Block
A Phase 4 study testing Systemic Dexamethasone and Perineural dexamethasone in people with Shoulder Surgery and Nerve Block, run by Dr. Stephen Choi at 1 site in Canada.
Trial summary
A standard interscalene nerve block is performed with long acting local anesthetic (bupivacaine or ropivacaine in concentrations varying from 0.25% to 0.75%). The purpose of this study is to investigate the effect of the addition of perineural dexamethasone (4mg) to a standard ropivacaine solution (0.5%) on analgesic… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Surgery, Nerve Block
- What is being tested?
- Systemic Dexamethasone and Perineural dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to May 2019
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing arthroscopic shoulder surgery at Sunnybrook Health Sciences Centre, Toronto Western Hospital and Women's College Hospital.
- ASA functional status class I to III
- Age 18 to 80 years
- BMI ≤ 35 kg/m2
Who cannot join
- Lack of patient consent
- Allergy to dexamethasone or ropivacaine
- BMI > 35 kg/m2
- Contraindications to low dose dexamethasone including peptic ulcer disease, systemic infection, glaucoma, active varicella/herpetic infections, diabetes mellitus
- Contraindications to ISB including severe Chronic Obstructive Pulmonary Disease (Forced expiratory volume < 40% predicted), coagulopathy, pre-existing neurologic deficit in ipsilateral upper extremity, localized infection
- Pregnant or nursing females
- Chronic opioid use defined as > 30mg oral morphine or equivalent per day
- Unable to take acetaminophen or celecoxib
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Perineural Versus Systemic Dexamethasone on Low Dose Interscalene Brachial Plexus Block: A Randomized Control Trial
A standard interscalene nerve block is performed with long acting local anesthetic (bupivacaine or ropivacaine in concentrations varying from 0.25% to 0.75%). The purpose of this study is to investigate the effect of the addition of perineural dexamethasone (4mg) to a standard ropivacaine solution (0.5%) on analgesic duration of low dose interscalene block compared to ropivacaine alone for interscalene block with systemic dexamethasone.
Ropivacaine is not an intervention as a local anesthetic is pre-requisite to performing a nerve block.
Read the detailed description
Interscalene brachial plexus block (ISB) is regarded as the standard of care for analgesia after shoulder surgery providing superior analgesia and reducing opioid consumption. Shoulder surgery, previously requiring inpatient admission for pain control, is now commonly performed on an ambulatory basis facilitated by ISB analgesia. The effects of single injection ISB dissipate after several hours unmasking the moderate to severe pain of the surgical insult and require strong opioid analgesia. Efforts to prolong ISB duration by increasing local anaesthetic (LA) dose are limited by their pharmacodynamics and narrow therapeutic window. To address some of these issues faced with prolonging ISB analgesia the addition of perineural adjuvants to local anesthetic (eg. clonidine, dexmedetomidine), have been investigated in an attempt to prolong peripheral nerve block duration with limited success. However, the corticosteroid dexamethasone, has been added to local anesthetic solutions for ISB and has demonstrated promise in preliminary studies. Perineural dexamethasone (8-10mg) in conjunction with local anesthetic prolongs the duration of ISB with an effect sizes ranging from 40% to 75% (absolute effect ~ 6 to 10 hours). Dexamethasone, however, is only approved for intramuscular or intravenous administration and therefore perineural use is currently off-label. There are several reasons that warrant a new randomized trial. Chiefly, all of the previous trials do not reflect modern regional anesthetic practice. These trials utilized peripheral nerve stimulation (PNS) and local anesthetic volumes of 30 to 40 ml. Modern ultrasound guided ISB (US-ISB) allows for more accurate, targeted deposition of local anesthetic with volumes ranging from 5 to 10 ml with no difference in block efficacy or duration compared to larger volumes (≥20ml). An ideal solution would be a local anesthetic with adjuvant mixture that allowed administration of lower volumes but with prolonged analgesic duration. The use of low dose local anesthetic with dexamethasone could be one such solution. A trial that demonstrates enhanced block quality and duration associated with perineural dexamethasone added to low dose local anesthetic may allow us to achieve both prolonged duration of effect and reduced side effects due to unwanted local anesthetic spread. This would create further significant benefits for patients and further promote the use of low dose local anesthetic techniques to anesthesiologists who do not currently use this technique.
- Conditions
- Shoulder Surgery, Nerve Block
- Being tested
- Systemic Dexamethasone, Perineural dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic DexamethasoneDrug
Also called Dexamethasone Sodium Phosphate Injection
Intravenous infusion of dexamethasone (4mg)
Perineural dexamethasoneDrug
Also called Dexamethasone Sodium Phosphate Injection
Perinerual administration of dexamethasone (4mg)
| Study group | Role | What they receive |
|---|---|---|
| Perineural Dexamethasone | Active comparator | ISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg) Receives: Drug: Perineural dexamethasone |
| Systemic Dexamethasone | Other | ISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg) Receives: Drug: Systemic Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Sensory Block
Defined as time from completion of block procedure to NRS for pain > 0 (in hours)
Measured: 1 day postoperative
Secondary outcomes (9)
Time to First Opioid Consumption
Defined as time from completion of block procedure to first consumption of opioid analgesic (in hours)
Measured: 1 day postoperative
Duration of Motor Block
Defined as time from completion of block procedure to return to baseline motor function (in hours)
Measured: 1 day postoperative
Post-operative Oxygen Saturation on Room Air
Pulse oximetry (in %) measured 1 hour after arrival in post-operative recovery room, scale 0-100, higher number is better
Measured: 1 hour postoperative
Opioid Consumption
Opioid consumption (in oral morphine equivalents) will be recorded at 12 hours, 24 hours, and 7 days
Measured: 7 days postoperative
Numeric Rating Scale for Pain (NRS 0-10)
Recorded at 12 hours, 24 hours, and 7 days 0 is no pain, 10 is the worst pain imaginable. Lower number is better.
Measured: 7 days postoperative
Postoperative Serum Blood Glucose
Measured 1 hour after arrival to the post-operative recovery room
Measured: 1 hour postoperative
Number of Participants With Nerve Damage From Interscalene Block
Defined as persistent paresthesia, and sensory/motor block at 7 days
Measured: 7 Days postoperative
Infection
Number of participants with localized infection at nerve block site
Measured: 7 Days postoperative
Number of Participants With Postoperative Nausea and/or Vomiting
Number of participants with postoperative nausea and/or vomiting assessed at 12 hours, 24, hours, and 7 days postoperatively
Measured: 7 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2019
- Study completionMay 2019
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 Shoulder SurgeryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Stephen Choi
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Sponsor-investigator, Dr. Stephen Choi, Sunnybrook Health Sciences Centre
- Investigators
- Stephen Choi, MD,FRCPC,MSc, Principal investigator, SunnybrookHealth Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322242
- Sponsor's protocol ID
- 437-2013
- Acronym
- ISB-Dex
- Status last verified
- Jul 2020
- First submitted
- 16 Dec 2014
- Last updated
- 15 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McHardy PG, Singer O, Awad IT, Safa B, Henry PDG, Kiss A, Au SK, Kaustov L, Choi S. Comparison of the effects of perineural or intravenous dexamethasone on low volume interscalene brachial plexus block: a randomised equivalence trial. Br J Anaesth. 2020 Jan;124(1):84-91. doi: 10.1016/j.bja.2019.08.025. Epub 2019 Oct 5.
PubMed 31591018
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Perineural Versus Systemic Dexamethasone on Low Dose Interscalene Brachial Plexus Block: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02322242
- Acronym / sponsor ID
- ISB-Dex / 437-2013
- Conditions
- Shoulder Surgery, Nerve Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Dr. Stephen ChoiUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Posted 7 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A standard interscalene nerve block is performed with long acting local anesthetic (bupivacaine or ropivacaine in concentrations varying from 0.25% to 0.75%). The purpose of this study is to investigate the effect of the addition of perineural dexamethasone (4mg) to a standard ropivacaine solution (0.5%) on analgesic duration of low dose interscalene block compared to ropivacaine alone for interscalene block with systemic dexamethasone.
Ropivacaine is not an intervention as a local anesthetic is pre-requisite to performing a nerve block.
Detailed description
Interscalene brachial plexus block (ISB) is regarded as the standard of care for analgesia after shoulder surgery providing superior analgesia and reducing opioid consumption. Shoulder surgery, previously requiring inpatient admission for pain control, is now commonly performed on an ambulatory basis facilitated by ISB analgesia. The effects of single injection ISB dissipate after several hours unmasking the moderate to severe pain of the surgical insult and require strong opioid analgesia. Efforts to prolong ISB duration by increasing local anaesthetic (LA) dose are limited by their pharmacodynamics and narrow therapeutic window. To address some of these issues faced with prolonging ISB analgesia the addition of perineural adjuvants to local anesthetic (eg. clonidine, dexmedetomidine), have been investigated in an attempt to prolong peripheral nerve block duration with limited success. However, the corticosteroid dexamethasone, has been added to local anesthetic solutions for ISB and has demonstrated promise in preliminary studies. Perineural dexamethasone (8-10mg) in conjunction with local anesthetic prolongs the duration of ISB with an effect sizes ranging from 40% to 75% (absolute effect ~ 6 to 10 hours). Dexamethasone, however, is only approved for intramuscular or intravenous administration and therefore perineural use is currently off-label. There are several reasons that warrant a new randomized trial. Chiefly, all of the previous trials do not reflect modern regional anesthetic practice. These trials utilized peripheral nerve stimulation (PNS) and local anesthetic volumes of 30 to 40 ml. Modern ultrasound guided ISB (US-ISB) allows for more accurate, targeted deposition of local anesthetic with volumes ranging from 5 to 10 ml with no difference in block efficacy or duration compared to larger volumes (≥20ml). An ideal solution would be a local anesthetic with adjuvant mixture that allowed administration of lower volumes but with prolonged analgesic duration. The use of low dose local anesthetic with dexamethasone could be one such solution. A trial that demonstrates enhanced block quality and duration associated with perineural dexamethasone added to low dose local anesthetic may allow us to achieve both prolonged duration of effect and reduced side effects due to unwanted local anesthetic spread. This would create further significant benefits for patients and further promote the use of low dose local anesthetic techniques to anesthesiologists who do not currently use this technique.
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 |
|---|---|---|
| Perineural Dexamethasone | Active comparator | Drug: Perineural dexamethasoneISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg) |
| Systemic Dexamethasone | Other | Drug: Systemic DexamethasoneISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing arthroscopic shoulder surgery at Sunnybrook Health Sciences Centre, Toronto Western Hospital and Women's College Hospital.
- ASA functional status class I to III
- Age 18 to 80 years
- BMI ≤ 35 kg/m2
Key exclusion criteria (8 listed)
- Lack of patient consent
- Allergy to dexamethasone or ropivacaine
- BMI > 35 kg/m2
- Contraindications to low dose dexamethasone including peptic ulcer disease, systemic infection, glaucoma, active varicella/herpetic infections, diabetes mellitus
- Contraindications to ISB including severe Chronic Obstructive Pulmonary Disease (Forced expiratory volume < 40% predicted), coagulopathy, pre-existing neurologic deficit in ipsilateral upper extremity, localized infection
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 |
|---|---|---|
| Systemic DexamethasoneAlso: Dexamethasone Sodium Phosphate InjectionIntravenous infusion of dexamethasone (4mg) | Drug | Systemic Dexamethasone |
| Perineural dexamethasoneAlso: Dexamethasone Sodium Phosphate InjectionPerinerual administration of dexamethasone (4mg) | Drug | Perineural Dexamethasone |
Primary outcome
Duration of Sensory Block
Time frame: 1 day postoperative
Defined as time from completion of block procedure to NRS for pain > 0 (in hours)
9 secondary outcomes
Time to First Opioid Consumption
Time frame: 1 day postoperative
Duration of Motor Block
Time frame: 1 day postoperative
Post-operative Oxygen Saturation on Room Air
Time frame: 1 hour postoperative
Opioid Consumption
Time frame: 7 days postoperative
Numeric Rating Scale for Pain (NRS 0-10)
Time frame: 7 days postoperative
Postoperative Serum Blood Glucose
Time frame: 1 hour postoperative
Number of Participants With Nerve Damage From Interscalene Block
Time frame: 7 Days postoperative
Infection
Time frame: 7 Days postoperative
Number of Participants With Postoperative Nausea and/or Vomiting
Time frame: 7 days postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31591018McHardy PG, Singer O, Awad IT, Safa B, Henry PDG, Kiss A, Au SK, Kaustov L, Choi S. Comparison of the effects of perineural or intravenous dexamethasone on low volume interscalene brachial plexus block: a randomised equivalence trial. Br J Anaesth. 2020 Jan;124(1):84-91. doi: 10.1016/j.bja.2019.08.025. Epub 2019 Oct 5.
- 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.
Stephen Choi, MD,FRCPC,MSc principal investigator
SunnybrookHealth Sciences Centre
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 Systemic Dexamethasone and Perineural dexamethasone in people with Shoulder Surgery and Nerve Block, run by Dr. Stephen Choi at 1 site 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 4 inclusion and 8 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 15 Jul 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 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. 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?
Yes. Results are posted in the registry (first posted 7 Jul 2020). 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 Sensory Block (time frame: 1 day postoperative). 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 NCT02322242, 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 15 Jul 2020.