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Drug SafetyPhase 3NCT01557270

Efficacy and Safety Study of Dexmedetomidine as an Additive to Local Anesthetics in Shoulder Surgery

A Phase 3 study testing dexmedetomidine and saline in people with Drug Safety and Self Efficacy, run by Prof. Peter Gerner, M.D. at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to test the efficacy and safety of dexmedetomidine added to ropivacaine in patients undergoing shoulder surgery. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Drug Safety, Self Efficacy
What is being tested?
dexmedetomidine and saline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteAustria
Study dates
Mar 2012to Nov 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ASA I-III adult subjects
  • Age 18-75
  • Elective shoulder surgery
  • Plan for interscalene brachial plexus block combined with general anesthesia
  • Interscalene block
  • Willingness to be contacted postoperatively for brief (5-10min) phone call questionnaires
  • Written informed consent

Who cannot join

  • Age < 18
  • Age > 75
  • Inability to understand protocol due to language barrier; difficulty with German language
  • 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 > 5) daily average pain
  • Daily use of gabapentin, pregabalin, tricyclic antidepressant, serotonin- norepinephrine reuptake inhibitor, tramadol
Show all 21Show fewer
  • Hypersensitivity to amide local anesthetics
  • History of hypersensitivity or allergic reaction to clonidine or dexmedetomidine
  • Uncontrolled anxiety
  • Schizophrenia or bipolar disorder
  • Preexisting nerve damage (sensory or motor) in the extremity to be blocked
  • Peripheral neuropathy
  • Significant cardiovascular disease (second (Mobitz II type) or third degree heart block, congestive heart failure, chronic heart failure NYHA III-IV, symptomatic coronary artery disease CSS III-IV)
  • BMI > 35
  • Uncontrolled diabetes (blood sugar > 250 recorded in last 30 days or HbA1c > 7.5%)
  • Chronic clonidine therapy (clonidine patch - Catapres or clonidine tablets)
  • Hepatic Impairment (CHILD B or higher)
  • Renal Impairment (creatinin > 2.0 mg/dl)
  • Ongoing drug or alcohol abuse
  • Pregnancy
  • Prisoners

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Paracelsus Medical University, Department of Anesthesiology, Perioperative and Intensive Care Medicine

    Salzburg, 5020

Other trials in Austria

About this study

Official title: The Efficacy and Safety of Dexmedetomidine as an Additive to Ropivacaine for Interscalene Brachial Plexus Blocks for Shoulder Surgery

The purpose of this study is to test the efficacy and safety of dexmedetomidine added to ropivacaine in patients undergoing shoulder surgery.

Read the detailed description

Peripheral nerve blocks are used throughout the world in lieu of general anesthesia and, more commonly, to provide analgesia and opioid sparing in the postoperative course. Long acting local anesthetics, such as ropivacaine, can provide analgesia for 11.5 ± 5 hours. This leads to many patients reporting their first pain in the evening and nighttime hours when access to healthcare providers and support is most limited. A number of additives to local anesthetics have been studied in humans with limited success. Recent work by a group in Michigan found a dose dependent increase in the duration of analgesia to a thermal stimulus when dexmedetomidine was added to ropivacaine for sciatic nerve blocks in rat.

The goal of the study is to investigate the safety and efficacy of dexmedetomidine added to ropivacaine 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 goals including the duration of analgesia, onset of sensory and motor blockade, and opioid-induced side effects. Tertiary outcomes will include subject satisfaction.

Being tested
dexmedetomidine, saline

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dexmedetomidineDrug

    ropivacaine 100 mg + 150 mcg dexmedetomidine, single shot perineural application

  • salineDrug

    ropivacaine + saline placebo, single shot perineural application

Study groups in NCT01557270
Study groupRoleWhat they receive
ropivacaine + dexmedetomidineExperimentalThis group represents the standard of care drug (ropivacaine) plus the new additive to be studied (dexmedetomidine)
Receives: Drug: dexmedetomidine
ropivacaine + salineActive comparatorThis group represents the current standard of care in peripheral nerve blockade
Receives: Drug: saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of dexmedetomidine in perineural application

    The time until the patient describes the blockade as completely gone will be analysed and compared between the groups.

    Measured: 24 hrs

  2. Safety of dexmedetomidine in perineural application

    Any serious and/or unexpected adverse (AE) events will be assessed on an individual basis by the Principal Investigator and the DSMB. After the first twenty subjects (10 controls and 10 receiving study agent) have completed the study, the data will be reviewed. Provided the DSMB determines the initial safety is established, enrollment will proceed until a total of 62 subjects (31 subjects/group) have been accrued.

    Measured: 30 days

Secondary outcomes (4)

  1. Analgesia

    Analgesia will be assessed based on postoperative pain scores

    Measured: first 24-48 hrs

  2. Onset of sensory blockade

    The subject's sensory function will be measured every 2 minutes for the first 20 minutes, until the loss of sensory function in the dermal distribution of the shoulder.

    Measured: every 3 minutes for the first 21 minutes

  3. Duration of motor blockade

    The time to return of motor strength will be recorded in the subject's postoperative course.

    Measured: first 24-48 hrs

  4. Opioid-induced side effects

    Opioid-induced side effects will be recorded in the subject's postoperative course.

    Measured: first 24-48 hrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionNov 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01557270
Sponsor's protocol ID
GernerDex001
Status last verified
Dec 2012
First submitted
5 Dec 2011
Last updated
4 Dec 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Brummett CM, Amodeo FS, Janda AM, Padda AK, Lydic R. Perineural dexmedetomidine provides an increased duration of analgesia to a thermal stimulus when compared with a systemic control in a rat sciatic nerve block. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):427-31. doi: 10.1097/AAP.0b013e3181ef4cf0.

    PubMed 20814283

  • Brummett CM, Hong EK, Janda AM, Amodeo FS, Lydic R. Perineural dexmedetomidine added to ropivacaine for sciatic nerve block in rats prolongs the duration of analgesia by blocking the hyperpolarization-activated cation current. Anesthesiology. 2011 Oct;115(4):836-43. doi: 10.1097/ALN.0b013e318221fcc9.

    PubMed 21666435

  • Brummett CM, Padda AK, Amodeo FS, Welch KB, Lydic R. Perineural dexmedetomidine added to ropivacaine causes a dose-dependent increase in the duration of thermal antinociception in sciatic nerve block in rat. Anesthesiology. 2009 Nov;111(5):1111-9. doi: 10.1097/ALN.0b013e3181bbcc26.

    PubMed 19858875

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing dexmedetomidine and saline in people with Drug Safety and Self Efficacy, run by Prof. Peter Gerner, M.D. at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of dexmedetomidine in perineural application (time frame: 24 hrs). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01557270, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2012.

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