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Trial record 65 of 406 for:    sodium phosphate

IV Dexamethasone for Prolongation of Peripheral Nerve Block

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ClinicalTrials.gov Identifier: NCT02864602
Recruitment Status : Completed
First Posted : August 12, 2016
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
This is a volunteer study examining the effect of different doses of IV dexamethasone on prolongation of median nerve block in the forearm.

Condition or disease Intervention/treatment Phase
Anesthesia, Conduction Drug: IV dexamethasone Phase 3

Detailed Description:
18 healthy volunteers aged 18-50 will be recruited (6 patients in each dosing group). Each volunteer will receive two forearm median nerve blocks separated by a two week washout period. One block will be conducted alongside an infusion of normal saline (control). The other block will be conducted alongside a randomised dose of IV dexamethasone (2, 4 or 8mg). The order of these interventions will be random. Blocks will be assessed quantitatively with cold and sharp sensation, electrical stimulation, quantitative sensory testing (thermal tolerance) and grip strength dynamometry. Measures or sensory and motor block including onset, intensity and duration will be compared between dosing groups.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Volunteer Study to Determine the Optimal Dose of IV Dexamethasone Required for Prolongation of Peripheral Nerve Block
Actual Study Start Date : November 12, 2016
Actual Primary Completion Date : February 20, 2018
Actual Study Completion Date : February 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexamethasone 2mg
The experimental intervention in this arm will be an IV infusion of 2mg of dexamethasone. Volunteers will also have a cross-over placebo comparator (saline infusion).
Drug: IV dexamethasone
An infusion of IV dexamethasone
Other Name: Dexamethasone sodium phosphate injection USP

Experimental: Dexamethasone 4mg
The experimental intervention in this arm will be an IV infusion of 4mg of dexamethasone. Volunteers will also have a cross-over placebo comparator (saline infusion).
Drug: IV dexamethasone
An infusion of IV dexamethasone
Other Name: Dexamethasone sodium phosphate injection USP

Experimental: Dexamethasone 8mg
The experimental intervention in this arm will be an IV infusion of 8mg of dexamethasone. Volunteers will also have a cross-over placebo comparator (saline infusion).
Drug: IV dexamethasone
An infusion of IV dexamethasone
Other Name: Dexamethasone sodium phosphate injection USP




Primary Outcome Measures :
  1. The duration of sensory anesthesia and analgesia following median nerve block [ Time Frame: This will be assessed for up to 12 hours following block ]

Secondary Outcome Measures :
  1. The duration of motor block following median nerve block [ Time Frame: This will be assessed for up to 12 hours following block ]
  2. Side effects related to nerve block or IV infusion of dexamethasone [ Time Frame: Volunteers will be phoned at 24-36 hrs and then 7-10 days to ensure full resolution of the block ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA 1 (normal healthy) volunteers.
  • 18 - 50 years of age.
  • 60 - 100kg weight.
  • English speaking.
  • Female volunteers of childbearing potential will be required to provide a negative pregnancy test before being allowed to participate.
  • Females of child bearing potential must be willing to use medically acceptable birth control methods between study interventions and for a minimum of 2 weeks following the second nerve block.

Exclusion Criteria:

  • Medical disorders (including bleeding disorders).
  • Use of systemic steroids within 2 weeks of the study, prescription medications, live viral vaccines or any recreational drug use.
  • Hypersensitivity to bupivacaine, dexamethasone or any component of saline.
  • Contraindication to regional anesthetic block.
  • Inability to provide informed consent.
  • Baseline abnormality of hand sensation or motor function.
  • Pregnancy / breast feeding.
  • Individuals with mental health disorders (for example bipolar disorder or depression).
  • Individuals with cataracts or glaucoma.
  • Any known contraindication to 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864602


Locations
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Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02864602     History of Changes
Other Study ID Numbers: 15-5049-A
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by University Health Network, Toronto:
Regional anesthesia
Adjuvant
Dexamethasone

Additional relevant MeSH terms:
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Dexamethasone 21-phosphate
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action