Effect of Intravenous Dexmedetomidine on Analgesic Duration of Infraclavicular Block

NCT01981369 | Completed

• 1 other identifier: 104572
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study will evaluate the effect of Dexmedetomidine sedation on the duration of infraclavicular block in patients scheduled for surgery of elbow, forearm and/or hand. All patients will receive infraclavicular block before the surgery and then they will be randomized to receive either Dexmedetomidine or Propofol sedation. Duration of the sensory block will be evaluated in recovery room, 24 and 48 hours after the surgery. Hypothesis: Primary: Dexmedetomidine sedation increases the duration of sensory infraclavicular block in patients scheduled for upper limb surgery. Secondary: Dexmedetomidine sedation

• Gives an adequate level of sedation during the surgical procedure
• Reduces the requirements of postoperative opioids
• Improves the quality of sleep on the night of the surgery
• Increases patients satisfaction regarding the anesthesia technique
• Dexmedetomidine sedation is safe and easy to use
• Dexmedetomidine sedation provides less respiratory depression during the procedure.

Conditions

Postoperative Pain

Keywords

Dexmedetomidine sedation; Regional Anesthesia; Infraclavicular block

Outcome Measures

Primary Outcomes (1)

• The duration of sensory infraclavicular block in patients scheduled for upper limb surgery.

  In the data collection form will be record the time of performance of the infraclavicular block. The patients will have a diary where they will record the time of the day when day have the first analgesic request because of pain in the surgical site.

  The primary outcome will be the duration of the sensory infraclavicular block in minutes, from the moment that the block is perfomed and the moment of first analgesic request.

Study Arms (2)

Propofol sedation.

ACTIVE COMPARATOR

This group will have infraclavicular block and sedation during surgery with intravenous Propofol. Patients will receive intravenous Propofol sedation 50-100 mcg/kg/min infusion. The infusion will be stopped 15 minutes before the end of surgery.

Drug: Propofol; Procedure: Infraclavicular block

Dexmedetomidine sedation.

EXPERIMENTAL

This group will have infraclavicular block and sedation with intravenous Dexmedetomidine. Patients will receive intravenous Dexmedetomidine sedation bolus 0.5mcg/kg in 10 minutes and then 0.2-0.5 mg/kg/hr infusion. The infusion will be stopped 15 minutes before the end of surgery.

Drug: Dexmedetomidine; Procedure: Infraclavicular block

Interventions

Dexmedetomidine DRUG

Intravenous sedation with dexmedetomidine

Also known as: Precedex

Dexmedetomidine sedation.

Propofol DRUG

Intravenous sedation with propofol

Propofol sedation.

Infraclavicular block PROCEDURE

All patients will receive ultrasound guided infraclavicular block with the standard protocol of the Block Room in St. Joseph Hospital.

Dexmedetomidine sedation.; Propofol sedation.

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and females of 16-80 years of age, scheduled for hand, forearm and elbow ambulatory surgery with an infraclavicular block.
• American Society of Anesthesiologist (ASA) Class I, II, III
• Ability to cooperate with study related procedures

You may not qualify if:

• ASA IV
• Narcotic dependent (opioid intake more than 3 months) or chronic pain conditions
• Associated significant cardiac or respiratory disease, neurological deficits
• Coexisting hematological disorder or with deranged coagulation
• Pre-existing major organ dysfunction
• Psychiatric illnesses
• Emergency surgery
• Lack of informed consent
• Allergy to any of the drugs used in the study
• Surgical procedure duration greater than 3 hours

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

Saint Joseph's Health Care London

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine; Propofol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Shalini Dhir, MD, FRCPC

  Lawson Health Research Institute & Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 11, 2013
• Study Start: January 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 29, 2019

Record last verified: 2019-05

Locations

CA (1)