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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Peter Gerner, M.D., Paracelsus Medical University
ClinicalTrials.gov Identifier:
NCT01557270
First received: December 5, 2011
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Drug Safety
Self Efficacy
Drug: dexmedetomidine
Drug: saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Dexmedetomidine as an Additive to Ropivacaine for Interscalene Brachial Plexus Blocks for Shoulder Surgery

Resource links provided by NLM:


Further study details as provided by Paracelsus Medical University:

Primary Outcome Measures:
  • Efficacy of dexmedetomidine in perineural application [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
    The time until the patient describes the blockade as completely gone will be analysed and compared between the groups.

  • Safety of dexmedetomidine in perineural application [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Analgesia [ Time Frame: first 24-48 hrs ] [ Designated as safety issue: No ]
    Analgesia will be assessed based on postoperative pain scores

  • Onset of sensory blockade [ Time Frame: every 3 minutes for the first 21 minutes ] [ Designated as safety issue: No ]
    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.

  • Duration of motor blockade [ Time Frame: first 24-48 hrs ] [ Designated as safety issue: No ]
    The time to return of motor strength will be recorded in the subject's postoperative course.

  • Opioid-induced side effects [ Time Frame: first 24-48 hrs ] [ Designated as safety issue: No ]
    Opioid-induced side effects will be recorded in the subject's postoperative course.


Enrollment: 62
Study Start Date: March 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ropivacaine + dexmedetomidine
This group represents the standard of care drug (ropivacaine) plus the new additive to be studied (dexmedetomidine)
Drug: dexmedetomidine
ropivacaine 100 mg + 150 mcg dexmedetomidine, single shot perineural application
Active Comparator: ropivacaine + saline
This group represents the current standard of care in peripheral nerve blockade
Drug: saline
ropivacaine + saline placebo, single shot perineural application

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557270

Locations
Austria
Paracelsus Medical University, Department of Anesthesiology, Perioperative and Intensive Care Medicine
Salzburg, Austria, 5020
Sponsors and Collaborators
Prof. Peter Gerner, M.D.
Investigators
Principal Investigator: Peter Gerner, MD Paracelsus Medical University Salzburg, Department of Anesthesiology
  More Information

Publications:
Responsible Party: Prof. Peter Gerner, M.D., Professor, Paracelsus Medical University
ClinicalTrials.gov Identifier: NCT01557270     History of Changes
Other Study ID Numbers: GernerDex001
Study First Received: December 5, 2011
Last Updated: December 3, 2012
Health Authority: Austria: Agency for Health and Food Safety
Austria: Ethikkommission

Additional relevant MeSH terms:
Anesthetics, Local
Ropivacaine
Dexmedetomidine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014