ClinicalTrials.gg
CompletedNCT03394820Updated Jul 17, 2024

The Optimal Time of IV Dexamethasone Administration for Prolongation of Peripheral Nerve Block

A Phase 4 interventional study of Dexamethasone in Peripheral Nerve Block Prolongation and Hand Injury Wrist, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-17.

Sponsored by University Health Network, Toronto · Phase 4, Interventional, and Other

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled May 2017, registered Sep 2017).
Phase
Phase 4
Study type
Interventional
Enrollment
197
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Peripheral Nerve Block Prolongation
  • Hand Injury Wrist

Keywords

  • Dexamethasone
  • Supraclavicular block
03

In context

Hand Injuries

122 studies on the registry are indexed under Hand Injuries; 35 are open to participants now.

This study's enrollment of 197 is above the median of 55 across 97 interventional studies indexed under Hand Injuries.

Browse Hand Injuries studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients having isolated hand or forearm surgery under anesthetic ultrasound - guided SCB
  • I - III
  • Age 18 - 80 years, inclusive
  • \<35

Exclusion criteria

Exclusion Criteria:

  • Pre - existing neuropathy or neurological deficit in the distribution of the nerves to be anaesthetized
  • 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 to local anesthetics and / or dexamethasone
  • Patients taking therapy
  • Positive pregnancy test
  • Inability to give
  • 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)
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
197 participants (actual)

Study arms

  • Active comparator
    dexamethasone 1 hour prior to block

    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.

    Drug: Dexamethasone

  • Experimental
    dexamethasone during the block

    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.

    Drug: Dexamethasone

  • Active comparator
    dexamethasone 1 hour after block

    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.

    Drug: Dexamethasone

  • Active comparator
    dexamethasone 2 hours after block

    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.

    Drug: Dexamethasone

Interventions

  • The intervention is the time when dexamethasone is administered

06

What researchers measure

Primary outcomes

  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.

    Time frame: from time from the end of the local anesthetic injection to patient report full freezing gone

Secondary outcomes

  1. Block onset time

    motor and sensation will be tested after the block is administered

    Time frame: 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)

    Time frame: 1 hour after surgery

  3. Measures of recovery

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

    Time frame: 1 hour after surgery

  4. Time of first analgesic consumption

    time from block onset to first outpatient analgesic

    Time frame: end of surgery to one week after surgery

  5. Motor block duration

    patient reported recovery of normal finger strength

    Time frame: one week after surgery

  6. Opioid consumption

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

    Time frame: time of block to 1 week after

  7. VAS Pain scores

    subjective pain scores

    Time frame: end of surgery to one week post- op

  8. Patient satisfaction

    Subjective reported satisfaction at specific time points

    Time frame: after surgery to one week after surgery

  9. Frequency and severity of adverse symptoms

    adverse symptoms related to the block

    Time frame: one week post operatively

  10. Pain Questionaire

    presence or absence of pain post-operatively

    Time frame: Three months after surgery

  11. total opioid consumption

    total PO morphine equivalent post operative

    Time frame: 1 hour after surgery

07

Study locations

1 site
  • Toronto Western Hopspital
    Toronto, Ontario M5T2S8, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2017 to primary completion in Nov 2023, 77 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 7, 2017
First posted
Jan 9, 2018
StartActual
May 30, 2017
Primary completionActual
Nov 23, 2023
CompletionActual
Feb 16, 2024
Last update
Jul 17, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03394820
Responsible party
Sponsor
First posted
Jan 9, 2018
Start date
May 30, 2017
Primary completion
Nov 23, 2023
Completion
Feb 16, 2024
Last update
Jul 17, 2024

Study contacts

Vincent Chan, MD,FRCPC
principal investigator · University Health Network, Toronto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Dexamethasone

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