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

NCT01557270 | Completed Phase 3 DMC

• 1 other identifier: GernerDex001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug Safety; Self Efficacy

Outcome Measures

Primary Outcomes (2)

• 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.

  24 hrs

• 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.

  30 days

Secondary Outcomes (4)

• Analgesia

  first 24-48 hrs

• Onset of sensory blockade

  every 3 minutes for the first 21 minutes

• Duration of motor blockade

  first 24-48 hrs

• Opioid-induced side effects

  first 24-48 hrs

Study Arms (2)

ropivacaine + dexmedetomidine

EXPERIMENTAL

This group represents the standard of care drug (ropivacaine) plus the new additive to be studied (dexmedetomidine)

Drug: dexmedetomidine

ropivacaine + saline

ACTIVE COMPARATOR

This group represents the current standard of care in peripheral nerve blockade

Drug: saline

Interventions

dexmedetomidine DRUG

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

ropivacaine + dexmedetomidine

saline DRUG

ropivacaine + saline placebo, single shot perineural application

ropivacaine + saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Prof. Peter Gerner, M.D.: lead

Study Sites (1)

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

Salzburg, 5020, Austria

Location

Related Publications (3)

• 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.

  PMID: 20814283 BACKGROUND

• 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.

  PMID: 21666435 BACKGROUND

• 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.

  PMID: 19858875 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Peter Gerner, MD

  Paracelsus Medical University Salzburg, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2011
• First Posted: March 19, 2012
• Study Start: March 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 4, 2012

Record last verified: 2012-12

Locations

AU (1)