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

NCT ID: NCT01557270

Last Updated: 2012-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-11-30

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.

Conditions

Drug Safety; Self Efficacy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ropivacaine + dexmedetomidine

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

Group Type: EXPERIMENTAL

dexmedetomidine

Intervention Type: DRUG

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

ropivacaine + saline

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

Group Type: ACTIVE_COMPARATOR

saline

Intervention Type: DRUG

ropivacaine + saline placebo, single shot perineural application

Interventions

dexmedetomidine

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

Intervention Type: DRUG

saline

ropivacaine + saline placebo, single shot perineural application

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Peter Gerner, M.D.

OTHER

Sponsor Role: lead

Responsible Party

Prof. Peter Gerner, M.D.

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Peter Gerner, MD

Role: PRINCIPAL_INVESTIGATOR

Paracelsus Medical University Salzburg, Department of Anesthesiology

Locations

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

Salzburg, , Austria

Countries

Austria

References

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.

Reference Type: BACKGROUND

PMID: 20814283 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21666435 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19858875 (View on PubMed)

Other Identifiers

GernerDex001

Identifier Type: -

Identifier Source: org_study_id