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

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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain; Nerve Pain
• Intervention / Treatment: Drug: Ropivacaine; Drug: Normal Saline; Drug: Dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 1B2
      • Women's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Ropivacaine,Normal Saline,Saline Bolus; Ropivacaine 15 mL 0.5% Normal Saline mL 0.9% Saline Bolus	Drug: Ropivacaine; 15 ml 0.5%; Other Names: Naropin; Drug: Normal Saline; 1 mL 0.9%
Experimental: Ropivacaine,Dexmedetomidine,Saline Bolus; Ropivacaine15 mL 0.5% Dexmedetomidine0.5 u/kg Saline Bolus	Drug: Ropivacaine; 15 ml 0.5%; Other Names: Naropin; Drug: Normal Saline; 1 mL 0.9%; Drug: Dexmedetomidine; 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; Other Names: Precedex
Active Comparator: Ropivacaine,Saline,Dexmedetomidine; Ropivacaine 15 mL 0.5% Normal Saline 1 mL 0.9% Dexmedetomidine single IV bolus 0.5 u/kg over 30 minutes	Drug: Ropivacaine; 15 ml 0.5%; Other Names: Naropin; Drug: Normal Saline; 1 mL 0.9%; Drug: Dexmedetomidine; 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; Other Names: Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Total use of opioids from the period of intra-operative to 2 weeks post-operative

Collaborators and Investigators

• Sponsor: Women's College Hospital
• Investigators: Principal Investigator: Richard M. Brull, MD, FRCPC, University of Toronto, Women's College Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: August 21, 2014
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 25, 2014

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: duration of analgesia
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Arthralgia; Neuralgia; Shoulder Pain; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Ropivacaine
• Other Study ID Numbers: DEX-2013