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

NCT03394820 | Completed Phase 4

• 1 other identifier: 16-5116-A
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Nerve Block Prolongation; Hand Injury Wrist

Keywords

Dexamethasone; Supraclavicular block

Outcome Measures

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.

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

Secondary Outcomes (11)

• Block onset time

  from time from the end of the local anesthetic injection (US - guided SCB) to surgical procedure start

• Measures of recovery

  1 hour after surgery

• Measures of recovery

  1 hour after surgery

• Time of first analgesic consumption

  end of surgery to one week after surgery

• Motor block duration

  one week after surgery

Study Arms (4)

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.

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.

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.

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.

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

The intervention is the time when dexamethasone is administered

dexamethasone 1 hour after block; dexamethasone 1 hour prior to block; dexamethasone 2 hours after block; dexamethasone during the block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hopspital

Toronto, Ontario, M5T2S8, Canada

Location

Related Publications (1)

• 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. 2024 Dec 25:rapm-2024-105923. doi: 10.1136/rapm-2024-105923. Online ahead of print.

  PMID: 39721764 DERIVED

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Vincent Chan, MD,FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The patient will be randomized prior to surgery. The pre-randomized envelope will be given to the anesthesia assistant by the blinded research associate. The anesthesia assistant will then prepare the four mini-bags labelled with the time each bag should be hung.The four bags will include 1 active drug and 3 placebo, to administer to the patient. The clinical fellow who will be administering the four doses will be blinded, as well as the research associate.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: January 9, 2018
• Study Start: May 30, 2017
• Primary Completion: November 23, 2023
• Study Completion: February 16, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)