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

Prof. Peter Gerner, M.D.62 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Drug Safety Self Efficacy

Interventions

dexmedetomidineDRUG

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

salineDRUG

ropivacaine + saline placebo, single shot perineural application

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Salzburg, Austria

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 30 days

Secondary Outcomes

Analgesia

Analgesia will be assessed based on postoperative pain scores

Time frame: first 24-48 hrs

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.

Time frame: every 3 minutes for the first 21 minutes

Duration of motor blockade

The time to return of motor strength will be recorded in the subject's postoperative course.

Time frame: first 24-48 hrs

Opioid-induced side effects

Opioid-induced side effects will be recorded in the subject's postoperative course.

Time frame: first 24-48 hrs

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.