Peripheral Nerve Block ProlongationPhase 4NCT03394820
The Optimal Time of IV Dexamethasone Administration for Prolongation of Peripheral Nerve Block
A Phase 4 study testing Dexamethasone in people with Peripheral Nerve Block Prolongation and Hand Injury Wrist, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to determine the optimal timing of IV dexamethasone for prolongation of ultrasound (US) guided supraclavicular brachial plexus block (SCB) in patients undergoing unilateral hand or forearm surgery at the Toronto Western Hospital. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Nerve Block Prolongation, Hand Injury Wrist
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteCanada
- Study dates
- 30 May 2017to 16 Feb 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having isolated hand or forearm surgery under anesthetic ultrasound - guided SCB
- ASA class I - III
- Age 18 - 80 years, inclusive
- BMI <35
Who cannot join
- Pre - existing neuropathy or neurological deficit in the distribution of the nerves to be anaesthetized
- Contra-indication to regional anesthesia / supraclavicular brachial plexus blockade; bleeding diathesis, coagulopathy, local infection, severe respiratory disease
- Anatomical deformity precluding block placement
- Patients with a known history of hypersensitivity to local anesthetics and / or dexamethasone
- Patients taking steroid therapy
- Positive pregnancy test
Show all 9Show fewer
- Inability to give informed consent
- Anticipated surgical time < 30 or > 180 minutes
- Any known contraindication for IV dexamethasone as per the product monograph:bacteremia and systemic fungal infections, hypersensitivity to any of the products components, gastric and duodenal ulcers, certain viral infections (i.e. varicella \& herpes genitalis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Optimal Time of IV Dexamethasone Administration for Prolongation of Peripheral Nerve Block
The purpose of this study is to determine the optimal timing of IV dexamethasone for prolongation of ultrasound (US) guided supraclavicular brachial plexus block (SCB) in patients undergoing unilateral hand or forearm surgery at the Toronto Western Hospital. Investigators seek to answer which timing of IV dexamethasone will provide the maximum block prolongation. Investigators hypothesize that IV dexamethasone administered either before or after the block will further extend the duration of analgesia provided.
Read the detailed description
This is a prospective double-blind randomized trial to evaluate the optimal timing of IV dexamethasone. All patients undergoing isolated hand or forearm surgery under anesthetic will be approached to participate. The patients will be consented on the day of surgery; all patients will be fully informed of the procedures involved in the study. Once the patient has consented to the study, they will be randomized to receive dexamethasone at one of four different times: 1 hour before the block, during the block, 1 hour after the block and 2 hours after the block.
In accordance with routine pre-block management, non-invasive blood pressure, electrocardiogram and pulse oximetry will be applied and intravenous access secured on the non-operative side for infusion of a 0.9% saline solution. Prior to block performance all patients will receive intravenous midazolam 1 - 4mg IV and / or fentanyl 25mcg IV for anxiolysis and analgesia, respectively, as needed. The US-guided SCB will be performed under sterile conditions by a staff regional anesthetist, regional anesthesia fellow or a directly supervised resident with experience of at least 10 US-guided SCB performed for each approach. Ultrasound examination above the clavicle will be performed using a high frequency linear probe (5 - 12 MHz range) with either a Philips, Sonosite or GE ultrasound machine. The brachial plexus, subclavian artery, first rib and pleura will be identified in the supraclavicular fossa. A 22 - gauge insulated 50mm needle (Stimuplex, Braun Medical, Bethlehem, PA) will be introduced in plane with the US and advanced to puncture the brachial plexus sheath. Typically this is accompanied by a palpable 'fascial click'. A small amount (0.5-1ml) of local anesthetic will be incrementally injected for needle tip hydro-location and/or hydro-dissection at the discretion of the operator. After placing the needle tip near the intersection of the first rib and the lateral aspect of the subclavian artery ('corner pocket') 30mls of 0.5% bupivacaine will be injected incrementally in 5ml aliquots with intermittent aspiration for blood.
A blinded research associate will evaluate sensory loss and motor blockade every 5 minutes until surgery starts.
Supplemental mask oxygen IV fluid replacement and full monitoring will be continued intraoperatively. Intravenous sedation will be used at the discretion of the attending anesthetist and according to the patient's wishes as is the standard of care at our institution. The dose of sedative and / or analgesic drugs will be recorded. Attendants will be asked to avoid any intraoperative steroid therapy. Surgical duration will be recorded for comparative analysis and exclusion of cases <30 or >180 minutes.
Following surgery, patients will be transferred to the post-operative care unit (PACU) or fast-tracked for discharge directly from the day case unit. The onset time of surgical pain (if applicable) and first analgesic request will be recorded. Once oral intake is established, patients will receive one of two analgesic preparations as needed; Tylenol#3® (acetaminophen 300mg/codeine 30mg/caffeine 15mg per tablet) or Percocet® (acetaminophen 325mg/oxycodone HCl 5mg) if intolerant to codeine. Patients will be evaluated at 1 and 2 hours postoperatively noting pain scores, analgesics received, block density and recovery criteria.
On discharge from hospital, patients will receive a prescription of Tylenol#3® as needed or Percocet® if intolerant to codeine. Patients will be given a home diary to complete. Patients will be requested to record the time at which they first experience pain at the surgical site, the time of first analgesic use and the time when they regain normal (or baseline equivalent) strength in their fingers. Patients will be asked to complete diary entries at 8 hrs, 24hrs, 48hrs and 7 days post operatively. They will be asked to document their visual analogue (VAS) pain score, cumulative analgesic consumption, side effects (numbness / tingling in the operative arm, weakness in the operative arm, pain around the injection site, bruising around the injection site, nausea and vomiting) and current VAS for satisfaction pertaining to the analgesia received. Patients will be telephoned at the aforementioned times to collect data from the diary, which was found the most reliable method of data collection during a previous study. Finally, patients will be phoned at 3 months to ensure no long - term numbness or weakness related to the nerve block.
The doses of oral codeine or oxycodone consumed by each patient will be converted into equi-analgesic doses of oral morphine sulphate in order to facilitate comparison between groups.
Sample size for the study:
A total of 220 participants will be randomized to receive dexamethasone at one of four different time points: 1 hour before the block, during the block, 1 hour after the block and 2 hours after the block.
- Being tested
- Dexamethasone
- Keywords
- Dexamethasone, Supraclavicular block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
The intervention is the time when dexamethasone is administered
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone 1 hour prior to block | Active comparator | The patient will receive dexamethasone through IV one hour prior to receiving their block. During the patient's block, 1 hour after and 2 hours after the block the patient will receive infusions of normal saline to maintain the blind. Receives: Drug: Dexamethasone |
| dexamethasone during the block | Experimental | The patient will receive dexamethasone through IV at the same time the patient has the SCB done. One hour prior to the block, one hour after the block and 2 hours after the block the patient will receive infusions of normal saline to maintain the blind. Receives: Drug: Dexamethasone |
| dexamethasone 1 hour after block | Active comparator | The patient will receive dexamethasone through IV one hour after the block has been administered. One hour prior to block, during the block and two hours after the block the patient will receive normal saline to maintain the blind. Receives: Drug: Dexamethasone |
| dexamethasone 2 hours after block | Active comparator | The patient will receive dexamethasone 2 hours after the block has been administered. One hour prior to the block, during the block and one hour after the block the patient will receive normal saline to maintain the blind. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block Duration
Sensory block duration i.e., time from the end of the local anesthetic injection (US - guided SCB) to the onset of pain at the surgical site.
Measured: from time from the end of the local anesthetic injection to patient report full freezing gone
Secondary outcomes (11)
Block onset time
motor and sensation will be tested after the block is administered
Measured: from time from the end of the local anesthetic injection (US - guided SCB) to surgical procedure start
Measures of recovery
total opioid consumption (total PO morphine equivalent post operative)
Measured: 1 hour after surgery
Measures of recovery
pain scores (0 no pain to 10 worst pain possible)
Measured: 1 hour after surgery
Time of first analgesic consumption
time from block onset to first outpatient analgesic
Measured: end of surgery to one week after surgery
Motor block duration
patient reported recovery of normal finger strength
Measured: one week after surgery
Opioid consumption
The amount of opioids the the patient consumes post-operatively will be monitored
Measured: time of block to 1 week after
VAS Pain scores
subjective pain scores
Measured: end of surgery to one week post- op
Patient satisfaction
Subjective reported satisfaction at specific time points
Measured: after surgery to one week after surgery
Frequency and severity of adverse symptoms
adverse symptoms related to the block
Measured: one week post operatively
Pain Questionaire
presence or absence of pain post-operatively
Measured: Three months after surgery
total opioid consumption
total PO morphine equivalent post operative
Measured: 1 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start30 May 2017
- Primary completion23 Nov 2023
- Study completion16 Feb 2024
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 Peripheral Nerve Block ProlongationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the patients will be randomized into four differently times groups. The patients will receive dexamethasone either 1 hour before the block, during the block, 1 hour after the block or 2 hours after the block
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Chan, MD,FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394820
- Sponsor's protocol ID
- 16-5116-A
- Status last verified
- Jul 2024
- First submitted
- 7 Sep 2017
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grass A, Chan V, Short AJ, Busser MJ, Chin KJ, Chowdhury J, Huszti E, Li Q, Perlas A. Timing of intravenous dexamethasone and analgesia after brachial plexus block: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2026 Mar 5;51(3):253-260. doi: 10.1136/rapm-2024-105923.
PubMed 39721764
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Optimal Time of IV Dexamethasone Administration for Prolongation of Peripheral Nerve Block
- ClinicalTrials.gov ID
- NCT03394820
- Acronym / sponsor ID
- 16-5116-A
- Keywords
- Dexamethasone, Supraclavicular block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 30 May 2017 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 9 Jan 2018 (actual)
- 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 purpose of this study is to determine the optimal timing of IV dexamethasone for prolongation of ultrasound (US) guided supraclavicular brachial plexus block (SCB) in patients undergoing unilateral hand or forearm surgery at the Toronto Western Hospital. Investigators seek to answer which timing of IV dexamethasone will provide the maximum block prolongation. Investigators hypothesize that IV dexamethasone administered either before or after the block will further extend the duration of analgesia provided.
Detailed description
This is a prospective double-blind randomized trial to evaluate the optimal timing of IV dexamethasone. All patients undergoing isolated hand or forearm surgery under anesthetic will be approached to participate. The patients will be consented on the day of surgery; all patients will be fully informed of the procedures involved in the study. Once the patient has consented to the study, they will be randomized to receive dexamethasone at one of four different times: 1 hour before the block, during the block, 1 hour after the block and 2 hours after the block.
In accordance with routine pre-block management, non-invasive blood pressure, electrocardiogram and pulse oximetry will be applied and intravenous access secured on the non-operative side for infusion of a 0.9% saline solution. Prior to block performance all patients will receive intravenous midazolam 1 - 4mg IV and / or fentanyl 25mcg IV for anxiolysis and analgesia, respectively, as needed. The US-guided SCB will be performed under sterile conditions by a staff regional anesthetist, regional anesthesia fellow or a directly supervised resident with experience of at least 10 US-guided SCB performed for each approach. Ultrasound examination above the clavicle will be performed using a high frequency linear probe (5 - 12 MHz range) with either a Philips, Sonosite or GE ultrasound machine. The brachial plexus, subclavian artery, first rib and pleura will be identified in the supraclavicular fossa. A 22 - gauge insulated 50mm needle (Stimuplex, Braun Medical, Bethlehem, PA) will be introduced in plane with the US and advanced to puncture the brachial plexus sheath. Typically this is accompanied by a palpable 'fascial click'. A small amount (0.5-1ml) of local anesthetic will be incrementally injected for needle tip hydro-location and/or hydro-dissection at the discretion of the operator. After placing the needle tip near the intersection of the first rib and the lateral aspect of the subclavian artery ('corner pocket') 30mls of 0.5% bupivacaine will be injected incrementally in 5ml aliquots with intermittent aspiration for blood.
A blinded research associate will evaluate sensory loss and motor blockade every 5 minutes until surgery starts.
Supplemental mask oxygen IV fluid replacement and full monitoring will be continued intraoperatively. Intravenous sedation will be used at the discretion of the attending anesthetist and according to the patient's wishes as is the standard of care at our institution. The dose of sedative and / or analgesic drugs will be recorded. Attendants will be asked to avoid any intraoperative steroid therapy. Surgical duration will be recorded for comparative analysis and exclusion of cases <30 or >180 minutes.
Following surgery, patients will be transferred to the post-operative care unit (PACU) or fast-tracked for discharge directly from the day case unit. The onset time of surgical pain (if applicable) and first analgesic request will be recorded. Once oral intake is established, patients will receive one of two analgesic preparations as needed; Tylenol#3® (acetaminophen 300mg/codeine 30mg/caffeine 15mg per tablet) or Percocet® (acetaminophen 325mg/oxycodone HCl 5mg) if intolerant to codeine. Patients will be evaluated at 1 and 2 hours postoperatively noting pain scores, analgesics received, block density and recovery criteria.
On discharge from hospital, patients will receive a prescription of Tylenol#3® as needed or Percocet® if intolerant to codeine. Patients will be given a home diary to complete. Patients will be requested to record the time at which they first experience pain at the surgical site, the time of first analgesic use and the time when they regain normal (or baseline equivalent) strength in their fingers. Patients will be asked to complete diary entries at 8 hrs, 24hrs, 48hrs and 7 days post operatively. They will be asked to document their visual analogue (VAS) pain score, cumulative analgesic consumption, side effects (numbness / tingling in the operative arm, weakness in the operative arm, pain around the injection site, bruising around the injection site, nausea and vomiting) and current VAS for satisfaction pertaining to the analgesia received. Patients will be telephoned at the aforementioned times to collect data from the diary, which was found the most reliable method of data collection during a previous study. Finally, patients will be phoned at 3 months to ensure no long - term numbness or weakness related to the nerve block.
The doses of oral codeine or oxycodone consumed by each patient will be converted into equi-analgesic doses of oral morphine sulphate in order to facilitate comparison between groups.
Sample size for the study:
A total of 220 participants will be randomized to receive dexamethasone at one of four different time points: 1 hour before the block, during the block, 1 hour after the block and 2 hours after the block.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 4
- Model description
- the patients will be randomized into four differently times groups. The patients will receive dexamethasone either 1 hour before the block, during the block, 1 hour after the block or 2 hours after the block
| Arm | Type | Receives |
|---|---|---|
| dexamethasone 1 hour prior to block | Active comparator | Drug: DexamethasoneThe patient will receive dexamethasone through IV one hour prior to receiving their block. During the patient's block, 1 hour after and 2 hours after the block the patient will receive infusions of normal saline to maintain the blind. |
| dexamethasone during the block | Experimental | Drug: DexamethasoneThe patient will receive dexamethasone through IV at the same time the patient has the SCB done. One hour prior to the block, one hour after the block and 2 hours after the block the patient will receive infusions of normal saline to maintain the blind. |
| dexamethasone 1 hour after block | Active comparator | Drug: DexamethasoneThe patient will receive dexamethasone through IV one hour after the block has been administered. One hour prior to block, during the block and two hours after the block the patient will receive normal saline to maintain the blind. |
| dexamethasone 2 hours after block | Active comparator | Drug: DexamethasoneThe patient will receive dexamethasone 2 hours after the block has been administered. One hour prior to the block, during the block and one hour after the block the patient will receive normal saline to maintain the blind. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients having isolated hand or forearm surgery under anesthetic ultrasound - guided SCB
- ASA class I - III
- Age 18 - 80 years, inclusive
- BMI <35
Key exclusion criteria (9 listed)
- Pre - existing neuropathy or neurological deficit in the distribution of the nerves to be anaesthetized
- Contra-indication to regional anesthesia / supraclavicular brachial plexus blockade; bleeding diathesis, coagulopathy, local infection, severe respiratory disease
- Anatomical deformity precluding block placement
- Patients with a known history of hypersensitivity to local anesthetics and / or dexamethasone
- Patients taking steroid therapy
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 |
|---|---|---|
| DexamethasoneThe intervention is the time when dexamethasone is administered | Drug | dexamethasone 1 hour after block, dexamethasone 1 hour prior to block, dexamethasone 2 hours after block, dexamethasone during the block |
Primary outcome
Block Duration
Time frame: from time from the end of the local anesthetic injection to patient report full freezing gone
Sensory block duration i.e., time from the end of the local anesthetic injection (US - guided SCB) to the onset of pain at the surgical site.
11 secondary outcomes
Block onset time
Time frame: from time from the end of the local anesthetic injection (US - guided SCB) to surgical procedure start
Measures of recovery
Time frame: 1 hour after surgery
Measures of recovery
Time frame: 1 hour after surgery
Time of first analgesic consumption
Time frame: end of surgery to one week after surgery
Motor block duration
Time frame: one week after surgery
Opioid consumption
Time frame: time of block to 1 week after
VAS Pain scores
Time frame: end of surgery to one week post- op
Patient satisfaction
Time frame: after surgery to one week after surgery
Frequency and severity of adverse symptoms
Time frame: one week post operatively
Pain Questionaire
Time frame: Three months after surgery
total opioid consumption
Time frame: 1 hour after surgery
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 17 Jul 2024.
- Derived from this study: PubMed 39721764Grass A, Chan V, Short AJ, Busser MJ, Chin KJ, Chowdhury J, Huszti E, Li Q, Perlas A. Timing of intravenous dexamethasone and analgesia after brachial plexus block: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2026 Mar 5;51(3):253-260. doi: 10.1136/rapm-2024-105923.
- Individual participant dataSharing planned: No
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.
Vincent Chan, MD,FRCPC principal investigator
University Health Network, Toronto
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 in people with Peripheral Nerve Block Prolongation and Hand Injury Wrist, run by University Health Network, Toronto 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 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 17 Jul 2024. 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?
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?
Block Duration (time frame: from time from the end of the local anesthetic injection to patient report full freezing gone). 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 NCT03394820, 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 17 Jul 2024.