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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Canada1 site
  • Toronto Western Hopspital

    Toronto, Ontario, M5T2S8

Other trials in Canada

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 groups in NCT03394820
Study groupRoleWhat they receive
dexamethasone 1 hour prior to blockActive comparatorThe 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 blockExperimentalThe 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 blockActive comparatorThe 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 blockActive comparatorThe 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.

  1. 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)
  1. 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

  2. Measures of recovery

    total opioid consumption (total PO morphine equivalent post operative)

    Measured: 1 hour after surgery

  3. Measures of recovery

    pain scores (0 no pain to 10 worst pain possible)

    Measured: 1 hour after surgery

  4. Time of first analgesic consumption

    time from block onset to first outpatient analgesic

    Measured: end of surgery to one week after surgery

  5. Motor block duration

    patient reported recovery of normal finger strength

    Measured: one week after surgery

  6. Opioid consumption

    The amount of opioids the the patient consumes post-operatively will be monitored

    Measured: time of block to 1 week after

  7. VAS Pain scores

    subjective pain scores

    Measured: end of surgery to one week post- op

  8. Patient satisfaction

    Subjective reported satisfaction at specific time points

    Measured: after surgery to one week after surgery

  9. Frequency and severity of adverse symptoms

    adverse symptoms related to the block

    Measured: one week post operatively

  10. Pain Questionaire

    presence or absence of pain post-operatively

    Measured: Three months after surgery

  11. 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.

  1. First posted9 Jan 2018
  2. Study start30 May 2017
  3. Primary completion23 Nov 2023
  4. Study completion16 Feb 2024

Resources

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)
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

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.

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