E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The goal of the present study is to investigate the safety and efficiacy 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 activity, sleep, and subject satisfaction. |
|
E.1.1.1 | Medical condition in easily understood language |
The goal of the present study is to investigate the safety and efficiacy of dexmedetomidine added to
ropivacaine for interscalene brachial plexus nerve block for shoulder surgery in humans. |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The goal of the present study is to investigate the safety of dexmedetomidine added to
ropivacaine for interscalene brachial plexus nerve block for shoulder surgery in humans |
|
E.2.2 | Secondary objectives of the trial |
The secondary goals include the duration of analgesia, onset of sensory and motor blockade, and opioid-induced side effects. Tertiary outcomes will include subject satisfaction. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
ASA I-III adult subjects
Age 18-65
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 |
|
E.4 | Principal 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
• History of hypersensitivity or allergic reaction to clonidine or dexmedetomidine
• Oxycodone allergy (oxycodone to be used for postoperative pain)
• Uncontrolled anxiety
• Schizophrenia or bipolar disorder
• Preexisting nerve damage (sensory or motor) in the extremity to be blocked
• Peripheral neuropathy
• Significant respiratory disease (chronic obstructive pulmonary disease or asthma
requiring daily therapy)
• Significant cardiovascular disease (second or third degree heart block, congestive heart
failure, symptomatic coronary artery disease)
• BMI > 35
• Uncontrolled diabetes (blood sugar > 250 recorded in last month)
• Chronic clonidine therapy (clonidine patch – Catapres or clonidine tablets)
• Hepatic Impairment
• Renal Impairment
• Ongoing drug or alcohol abuse
• Local cutaneous infection at site of nerve block placement
• Hearing impairment
• Pregnancy
• Prisoners |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Establish the safety of the combination of dexmedetomidine and ropivacaine for interscalene brachial plexus blocks for shoulder surgery in humans. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
beginning 4 hours after block untill 10pm, follow-up on day 3, 4, 9 and 30 |
|
E.5.2 | Secondary end point(s) |
• Duration of postoperative analgesia as measured by the time to first painful sensation in
the operative arm.
• Quality of postoperative analgesia as measured by average pain score over the first 24
and 48 hours.
• Duration of motor blockade as measured by the time to which a subject is able to move
their operative arm.
• Onset of sensory blockade immediately after the nerve block.
• Onset of motor blockade immediately after the nerve block.
• Opioid-induced side effects. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
beginning 4 hours after block untill 10pm, follow-up on day 3, 4, 9 and 30 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Day 30 after last follow-up phone call |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |