EUCTR2011-002175-42-AT
Active, not recruiting
Not Applicable
The effect and safety of dexmedetomidine as an additive to ropivacaine for interscalene brachial plexus blocks for shoulder surgery
Paracelsus Medizinische Universität - Universitätsklinik für Anästhesie0 sitesSeptember 5, 2011
ConditionsThe 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]
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- 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.
- Sponsor
- Paracelsus Medizinische Universität - Universitätsklinik für Anästhesie
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •ASA I\-III adult subjects
- •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
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
Outcomes
Primary Outcomes
Not specified
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