- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03394820
The Optimal Time of IV Dexamethasone Administration for Prolongation of Peripheral Nerve Block
Determining the Optimal Time of IV Dexamethasone Administration for Prolongation of Peripheral Nerve Block
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Vincent Chan, MD
- Phone Number: 4167906440
- Email: vincent.chan@uhn.ca
Study Contact Backup
- Name: Mehdi Soheili, MD
- Phone Number: 2016 4166035800
- Email: Mehdi.Soheili@uhnresearch.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5T2S8
- Recruiting
- Toronto Western Hopspital
-
Principal Investigator:
- Vincent Chan, MD. FRCPC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients having isolated hand or forearm surgery under anesthetic ultrasound - guided SCB
- ASA class I - III
- Age 18 - 80 years, inclusive
- BMI <35
Exclusion Criteria:
- 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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
The intervention is the time when dexamethasone is administered
|
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.
|
The intervention is the time when dexamethasone is administered
|
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.
|
The intervention is the time when dexamethasone is administered
|
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.
|
The intervention is the time when dexamethasone is administered
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
from time from the end of the local anesthetic injection to patient report full freezing gone
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Block onset time
Time Frame: from time from the end of the local anesthetic injection (US - guided SCB) to surgical procedure start
|
motor and sensation will be tested after the block is administered
|
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
|
total opioid consumption (total PO morphine equivalent post operative)
|
1 hour after surgery
|
Measures of recovery
Time Frame: 1 hour after surgery
|
pain scores (0 no pain to 10 worst pain possible)
|
1 hour after surgery
|
Time of first analgesic consumption
Time Frame: end of surgery to one week after surgery
|
time from block onset to first outpatient analgesic
|
end of surgery to one week after surgery
|
Motor block duration
Time Frame: one week after surgery
|
patient reported recovery of normal finger strength
|
one week after surgery
|
Opioid consumption
Time Frame: time of block to 1 week after
|
The amount of opioids the the patient consumes post-operatively will be monitored
|
time of block to 1 week after
|
VAS Pain scores
Time Frame: end of surgery to one week post- op
|
subjective pain scores
|
end of surgery to one week post- op
|
Patient satisfaction
Time Frame: after surgery to one week after surgery
|
Subjective reported satisfaction at specific time points
|
after surgery to one week after surgery
|
Frequency and severity of adverse symptoms
Time Frame: one week post operatively
|
adverse symptoms related to the block
|
one week post operatively
|
Pain Questionaire
Time Frame: Three months after surgery
|
presence or absence of pain post-operatively
|
Three months after surgery
|
total opioid consumption
Time Frame: 1 hour after surgery
|
total PO morphine equivalent post operative
|
1 hour after surgery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Hand Injuries
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
Other Study ID Numbers
- 16-5116-A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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