The Effect of Dexmedetomidine on Brachial Plexus Block for Shoulder Surgery

NCT02225054 | Completed Phase 2

• 1 other identifier: DEX-2013
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a small dose of Dexmedetomidine, when given either intravenously or as part of the interscalene nerve block solution, prolongs pain relief following shoulder surgery compared to local anesthetic solution alone.

Conditions

Nerve Pain; Shoulder Pain

Keywords

duration of analgesia

Outcome Measures

Primary Outcomes (2)

• Duration of interscalene nerve block.

  Duration of time is from the end of local anesthetic injection (interscalene block) to the onset of pain at the surgical site.

• Opioid consumption

  Cumulative opioid consumption at 24 hours postoperatively

Secondary Outcomes (1)

• Opioid Consumption

  Total use of opioids from the period of intra-operative to 2 weeks post-operative

Study Arms (3)

Ropivacaine,Normal Saline,Saline Bolus

PLACEBO COMPARATOR

Ropivacaine 15 mL 0.5% Normal Saline mL 0.9% Saline Bolus

Drug: Ropivacaine; Drug: Normal Saline

Ropivacaine,Dexmedetomidine,Saline Bolus

EXPERIMENTAL

Ropivacaine15 mL 0.5% Dexmedetomidine0.5 u/kg Saline Bolus

Drug: Dexmedetomidine; Drug: Ropivacaine; Drug: Normal Saline

Ropivacaine,Saline,Dexmedetomidine

ACTIVE COMPARATOR

Ropivacaine 15 mL 0.5% Normal Saline 1 mL 0.9% Dexmedetomidine single IV bolus 0.5 u/kg over 30 minutes

Drug: Dexmedetomidine; Drug: Ropivacaine; Drug: Normal Saline

Interventions

Dexmedetomidine DRUG

0.5 u/kg Dexmedetomidine diluted in saline to 1 mL (single interscalene injection) Dexmedetomidine 0.5 u/kg as a single IV bolus over 30 minutes following GA induction

Also known as: Precedex

Ropivacaine,Dexmedetomidine,Saline Bolus; Ropivacaine,Saline,Dexmedetomidine

Ropivacaine DRUG

15 ml 0.5%

Also known as: Naropin

Ropivacaine,Dexmedetomidine,Saline Bolus; Ropivacaine,Normal Saline,Saline Bolus; Ropivacaine,Saline,Dexmedetomidine

Normal Saline DRUG

1 mL 0.9%

Ropivacaine,Dexmedetomidine,Saline Bolus; Ropivacaine,Normal Saline,Saline Bolus; Ropivacaine,Saline,Dexmedetomidine

Eligibility Criteria

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

You may qualify if:

• unilateral surgical shoulder procedures under general anesthetic
• English speaking patients
• ASA I-III patients
• BMI \<38 kg/m2

You may not qualify if:

• proximal clavicular surgery
• preexisting neurological deficits or peripheral neuropathy
• known coronary heart disease, congestive heart failure, cardiomyopathies, or arrhythmias
• known cerebrovascular disease
• baseline heart rate \<60 beats per minute or baseline systolic blood pressure \<100 mm Hg
• medications that reduce heart rate (as beta-blockers, calcium blockers) known liver dysfunction or existing diseases known to cause hepatic or renal impairment
• severe bronchopulmonary disease
• local infection
• contra-indication to regional anesthesia (bleeding, coagulopathy)
• chronic pain disorders
• current use of over 30mg oxycodone or equivalent per day
• contraindication to a component of multimodal analgesia
• allergy to local anesthetics or dexmedetomidine
• history of significant psychiatric conditions that may affect patient assessment
• pregnancy

Sponsors & Collaborators

• Women's College Hospital: lead

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

MeSH Terms

Conditions

Neuralgia; Shoulder Pain

Interventions

Dexmedetomidine; Ropivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Richard M. Brull, MD, FRCPC

  University of Toronto, Women's College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 25, 2014
• Study Start: May 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

CA (1)