The effect and safety of dexmedetomidine as an additive to ropivacaine for interscalene brachial plexus blocks (regional anesthesia) for shoulder surgery

• Conditions: The goal of the present study is to investigate the safety and efficiacy of dexmedetomidine added toropivacaine for interscalene brachial plexus nerve block for shoulder surgery in humans.Provided the initial safety can be established, the trial will continue to evaluate secondary goalsincluding the duration of analgesia, onset of sensory and motor blockade, and opioid-inducedside effects. Tertiary outcomes will include activity, sleep, and subject satisfaction.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2011-002175-42-AT
• Lead Sponsor: Paracelsus Medizinische Universität - Universitätsklinik für Anästhesie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-05
• Last Update Posted: 8 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

ASA I-III adult subjects
Age 18-65
Elective shoulder surgery
Plan for interscalene brachial plexus block combined with general anesthesia
Interscalene block placed between 7:00 a.m. and 12:00 a.m.
Willingness to be contacted postoperatively for brief (5-10 min) phone call
questionnaires
Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Age < 18
• Age > 65
• Inability to understand protocol due to language barrier
• Coagulation/bleeding disorders
• Chronic pain requiring daily opioids > 15 mg oral morphine equivalents (equals oral
usage of > 10 mg oxycodone/daily; > 5 mg methadone/day; > 4 mg hydromorphone/day)
• Moderate (NRS pain score > 3) daily average pain
• Daily use of gabapentin, pregabalin, tricyclic antidepressant, serotonin-norepinephrine
reuptake inhibitor, tramadol, corticosteroids
• Hypersensitivity to amide local anesthetics
• History of hypersensitivity or allergic reaction to clonidine or dexmedetomidine
• Oxycodone allergy (oxycodone to be used for postoperative pain)
• Uncontrolled anxiety
• Schizophrenia or bipolar disorder
• Preexisting nerve damage (sensory or motor) in the extremity to be blocked
• Peripheral neuropathy
• Significant respiratory disease (chronic obstructive pulmonary disease or asthma
requiring daily therapy)
• Significant cardiovascular disease (second or third degree heart block, congestive heart
failure, symptomatic coronary artery disease)
• BMI > 35
• Uncontrolled diabetes (blood sugar > 250 recorded in last month)
• Chronic clonidine therapy (clonidine patch – Catapres or clonidine tablets)
• Hepatic Impairment
• Renal Impairment
• Ongoing drug or alcohol abuse
• Local cutaneous infection at site of nerve block placement
• Hearing impairment
• Pregnancy
• Prisoners

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The goal of the present study is to investigate the safety of dexmedetomidine added to<br>ropivacaine for interscalene brachial plexus nerve block for shoulder surgery in humans;Secondary Objective: The secondary goals include the duration of analgesia, onset of sensory and motor blockade, and opioid-induced side effects. Tertiary outcomes will include subject satisfaction.;Primary end point(s): Establish the safety of the combination of dexmedetomidine and ropivacaine for interscalene brachial plexus blocks for shoulder surgery in humans.;Timepoint(s) of evaluation of this end point: beginning 4 hours after block untill 10pm, follow-up on day 3, 4, 9 and 30

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Duration of postoperative analgesia as measured by the time to first painful sensation in<br>the operative arm.<br>• Quality of postoperative analgesia as measured by average pain score over the first 24<br>and 48 hours.<br>• Duration of motor blockade as measured by the time to which a subject is able to move<br>their operative arm.<br>• Onset of sensory blockade immediately after the nerve block.<br>• Onset of motor blockade immediately after the nerve block.<br>• Opioid-induced side effects.;Timepoint(s) of evaluation of this end point: beginning 4 hours after block untill 10pm, follow-up on day 3, 4, 9 and 30