Clinical trial NCT01557270: Efficacy and Safety Study of Dexmedetomidine as an Additive to Local Anesthetics in Shoulder Surgery
Official title: The Efficacy and Safety of Dexmedetomidine as an Additive to Ropivacaine for Interscalene Brachial Plexus Blocks for Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Drug Safety
Self Efficacy
Lead sponsor: Paracelsus Medical University
Sponsor class: OTHER
First posted: 2012-03-19
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Efficacy of dexmedetomidine in perineural application
timeFrame: 24 hrs
measure: Safety of dexmedetomidine in perineural application
timeFrame: 30 days
Secondary outcomes:
measure: Analgesia
timeFrame: first 24-48 hrs
measure: Onset of sensory blockade
timeFrame: every 3 minutes for the first 21 minutes
measure: Duration of motor blockade
timeFrame: first 24-48 hrs
measure: Opioid-induced side effects
timeFrame: first 24-48 hrs
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Paracelsus Medical University, Department of Anesthesiology, Perioperative and Intensive Care Medicine
Study officials:
affiliation: Paracelsus Medical University Salzburg, Department of Anesthesiology
name: Peter Gerner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.