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The Effect of Dexmedetomidine on Brachial Plexus Block for Shoulder Surgery (DEX)

Primary Purpose

Nerve Pain, Shoulder Pain

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Dexmedetomidine
Ropivacaine
Normal Saline
Sponsored by
Women's College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nerve Pain focused on measuring duration of analgesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • inability to provide consent

Sites / Locations

  • Women's College Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Ropivacaine,Normal Saline,Saline Bolus

Ropivacaine,Dexmedetomidine,Saline Bolus

Ropivacaine,Saline,Dexmedetomidine

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Duration of interscalene nerve block.
Opioid consumption

Secondary Outcome Measures

Opioid Consumption
The total amount of opioid use starting from during surgery to 14 days following surgery. Opioid side effects, patient satisfaction with pain control and the time to discharge from hospital will all be assessed Any evidence of nerve block complications at 3 months, post-block administration , will also be assessed.

Full Information

First Posted
August 21, 2014
Last Updated
November 2, 2017
Sponsor
Women's College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02225054
Brief Title
The Effect of Dexmedetomidine on Brachial Plexus Block for Shoulder Surgery
Acronym
DEX
Official Title
The Analgesic Effect of Dexmedetomidine as an Adjunct to Local Anesthetics in Ultrasound-guided Interscalene Approach to Brachial Plexus Block for Shoulder Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's College Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Unilateral shoulder surgical procedures, including acromioplasty, rotator cuff repair and Bankart procedure generally allow the patient to go home the same day. However, post-surgical pain is often severe and it is common to encounter a delay in discharge from the hospital due to difficulty in pain control. Single shot interscalene block is used in ambulatory shoulder surgery for its advantages that included a significant reduction in acute pain and analgesic requirements, prolonged time to first analgesic request, decreased incidence of nausea, as well as earlier hospital discharge. Previous studies have attempted to prolong the duration of the analgesia of interscalene block by administering additional drugs to the local anesthetics but these studies have had varying degrees of success. Dexmedetomidine has recently been considered as a potentially useful drug in prolonging nerve block analgesia. Various modes of administration of Dexmedetomidine have demonstrated a consistent effect on the duration of analgesia. So far, the systemic infusion of Dex has been shown to prolong both neuraxial and peripheral nerve blocks. When combined with local anesthetics in intravenous regional anesthesia 9IVRA), Dex enhanced the duration of analgesia. Furthermore, data from animal studies strongly support the use of Dex as a safe potent adjunct to local anesthetics capable of prolonging the duration of analgesia of peripheral nerve blocks. The use of Dexmedetomidine as an adjunct in interscalene block has not been studied yet. This trial will study the effects of adding Dexmedetomidine as an adjunct to local anesthetics in interscalene brachial plexus block.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nerve Pain, Shoulder Pain
Keywords
duration of analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine,Normal Saline,Saline Bolus
Arm Type
Placebo Comparator
Arm Description
Ropivacaine 15 mL 0.5% Normal Saline mL 0.9% Saline Bolus
Arm Title
Ropivacaine,Dexmedetomidine,Saline Bolus
Arm Type
Experimental
Arm Description
Ropivacaine15 mL 0.5% Dexmedetomidine0.5 u/kg Saline Bolus
Arm Title
Ropivacaine,Saline,Dexmedetomidine
Arm Type
Active Comparator
Arm Description
Ropivacaine 15 mL 0.5% Normal Saline 1 mL 0.9% Dexmedetomidine single IV bolus 0.5 u/kg over 30 minutes
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
15 ml 0.5%
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
1 mL 0.9%
Primary Outcome Measure Information:
Title
Duration of interscalene nerve block.
Time Frame
Duration of time is from the end of local anesthetic injection (interscalene block) to the onset of pain at the surgical site.
Title
Opioid consumption
Time Frame
Cumulative opioid consumption at 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Opioid Consumption
Description
The total amount of opioid use starting from during surgery to 14 days following surgery. Opioid side effects, patient satisfaction with pain control and the time to discharge from hospital will all be assessed Any evidence of nerve block complications at 3 months, post-block administration , will also be assessed.
Time Frame
Total use of opioids from the period of intra-operative to 2 weeks post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: unilateral surgical shoulder procedures under general anesthetic English speaking patients ASA I-III patients BMI <38 kg/m2 Exclusion Criteria: 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 inability to provide consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard M. Brull, MD, FRCPC
Organizational Affiliation
University of Toronto, Women's College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada

12. IPD Sharing Statement

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The Effect of Dexmedetomidine on Brachial Plexus Block for Shoulder Surgery

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