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

Self Efficacy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557270
• Other study ID #: GernerDex001
• Status: Completed
• Phase: Phase 3
• First received: December 5, 2011
• Last updated: December 3, 2012
• Start date: March 2012
• Est. completion date: November 2012

Study information

• Verified date: December 2012
• Source: Paracelsus Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyAustria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Safety
• Self Efficacy

Intervention

Drug:
• dexmedetomidine
ropivacaine 100 mg + 150 mcg dexmedetomidine, single shot perineural application
• saline
ropivacaine + saline placebo, single shot perineural application

Locations

Country	Name	City	State
Austria	Paracelsus Medical University, Department of Anesthesiology, Perioperative and Intensive Care Medicine	Salzburg

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Peter Gerner, M.D.

Country where clinical trial is conducted

Austria, 

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	Analgesia	Analgesia will be assessed based on postoperative pain scores	first 24-48 hrs	No
Secondary	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.	every 3 minutes for the first 21 minutes	No
Secondary	Duration of motor blockade	The time to return of motor strength will be recorded in the subject's postoperative course.	first 24-48 hrs	No
Secondary	Opioid-induced side effects	Opioid-induced side effects will be recorded in the subject's postoperative course.	first 24-48 hrs	No