Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the analgesic efficacy of DMTS, compared with placebo, in subjects following abdominoplasty.

Detailed Description
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This is a randomized, double-blind, placebo-controlled, one-time application study of DMTS or matching placebo over a 4-day treatment period (Day 1 Time 0 occurs when the DMTS or matching placebo systems have been applied). Subjects scheduled for an abdominoplasty will be screened up to 28 days prior to surgery. Eligible subjects will be randomized equally to treatment with DMTS or matching placebo. An independent safety monitoring committee will periodically review unblinded safety data to confirm the safety/tolerability of the dose or recommend a dose reduction.

Official Title
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A Double-Blind, Placebo-Controlled Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: DMTS Patch
* Drug: Placebo Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, ≥ 18 years of age. Scheduled to undergo a full abdominoplasty (including repair of small incidental abdominal hernias, but not including liposuction). Have a physical status classification of 1 or 2 per the American Society of Anesthesiology. Have a body weight > 58 kg, and body mass index of 20 to 38 kg/m2, inclusive. Exclusion Criteria: Known sensitivity to dexmedetomidine or any excipient in the DMTS/placebo or to any peri- or postoperative medication whose use is required in this study. Skin abnormality (eg, scar, tattoo) or unhealthy skin condition (eg, burns, wounds) at the DMTS/matching placebo application site, according to examination by the investigator at screening or admission to the clinic prior to surgery. History of deep vein thrombosis or factor V Leiden deficiency. History of syncope or other syncopal attacks. Present and/or significant history of postural hypotension (determined through examination by the investigator or designee), or history of severe dizziness or fainting on standing in the opinion of the investigator. Evidence of a clinically significant 12-lead ECG abnormality.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized in 1:1 ratio to receive DMTS or matching placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DMTS Patch<br>DMTS applied to upper outer arm | Drug: DMTS Patch<br>* DMTS applied before surgery and worn for 96 hours<br>* Other names: DMTS;|
| Placebo Comparator: Placebo Patch<br>Placebo system (with no drug) to match DMTS applied to the upper arm | Drug: Placebo Patch<br>* Matching patches that have no active drug applied before surgery and worn for 96 hours<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-interval weighted summed pain intensity (SPI) at designated time points | The SPI measured using the 11-point (0 to 10) numeric rating scale, where 0 is equal to no pain and 10 is equal to worst pain | 5 to 96 hours following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-interval weighted summed pain intensity (SPI) over various time intervals | The SPI measured using the 11-point (0 to 10) numeric rating scale, where 0 is equal to no pain and 10 is equal to worst pain, measured at rest over various time intervals | 5 to 96 hours following surgery | 
| Rescue Medication | The proportion of subjects using rescue analgesic medication | Up to 96 hours post surgery | 
| Rescue Medication units | Total dose of rescue analgesic medication (in morphine-equivalent units) | Up to 96 hours post surgery | 
| Integrated Pain score and Rescue Medication | Integrated assessment of summed pain intensity (SPI) using the 11-point (0 to 10) numeric rating scale, where 0 is equal to no pain and 10 is equal to worst pain, at the time Rescue Medication was administered | Up to 96 hours post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominoplasty, Pain, Transdermal, DMTS