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UNKNOWNPHASE2

Evaluating Efficacy of the Dexmedetomidine Transdermal System for Postoperative Analgesia Following Abdominoplasty

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

NCT04242407•Teikoku Pharma USA, Inc.

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the analgesic efficacy of Dexmedetomidine Transdermal System (DMTS), compared with placebo, in participants following abdominoplasty.

Detailed Description

This is a randomized, double-blind, placebo-controlled, one-time application study of DMTS or matching placebo over a 4-day treatment period. Eligible subjects will be randomized in 1:1 ratio to receive DMTS or matching placebo. Subjects will reside at the clinical study unit for up to a total of 7 days. The surgical procedure, the intraoperative anesthesia, and the medication used for infiltration of the wound for local anesthesia before the last stitch will be standardized. During the postoperative period in the clinical study unit, recovery procedures will be standardized.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntarily provide written informed consent.
•2. Male or female, ≥ 18 years of age.
•3. Scheduled to undergo a full abdominoplasty (including repair of small incidental abdominal hernias but not including liposuction).
•4. Have a physical status classification of 1 or 2 per the American Society of Anesthesiology.
•5. Female subjects are eligible only if all the following apply:
•1. Not pregnant, not lactating, and not planning to become pregnant during the study or for 1 menstrual cycle thereafter
•2. Surgically sterile; or at least 2 years postmenopausal; or have a monogamous partner who is surgically sterile; or have a same gender sex partner; or is using double-barrier contraception; or practicing abstinence; or using an insertable, injectable, transdermal, or combination oral contraceptive for 3 months prior to the study, during the study, and for 1 month following the study
•6. Male subjects with female sex partners of childbearing potential must be surgically sterile or commit to use a reliable method of birth control during the study and for 1 month following the study.
•7. Have a body weight \> 58 kg and a BMI of 20 to 38 kg/m2, inclusive.
•8. Able to understand the study procedures, comply with all study procedures, and agree to participate in the study program for its full duration.

Exclusion Criteria

•1. 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.
•2. Skin abnormality (eg, scar, tattoo) or unhealthy skin condition (eg, burns, wounds) at the DMTS/matching placebo system application site, according to examination by the investigator at screening or admission to the clinic prior to surgery.
•3. Clinically significant abnormal clinical laboratory test value.
•4. History of deep vein thrombosis or factor V Leiden deficiency.
•5. History of or positive test results for the human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
•6. History or clinical manifestations of: a significant renal, hepatic, cardiovascular, metabolic, neurologic, or psychiatric condition; congestive heart failure, peptic ulcer, gastrointestinal bleeding, or other condition that may preclude participation in the study.
•7. History of physician-diagnosed migraine, frequent non-vascular headaches (\> 5 per month), seizures, or are currently taking anticonvulsants.
•8. Have another painful physical condition that may confound the assessments of postoperative pain.
•9. History of syncope or other syncopal attacks.
•10. 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.
+13 more criteria

Locations (4)

Arizona Research Center

Phoenix, Arizona, United States

HD Research

Bellaire, Texas, United States

Endeavor Clinical Trials

San Antonio, Texas, United States

JBR Clinical Research

Salt Lake City, Utah, United States

Key Dates

Start Date

July 7, 2020

Primary Completion Date

February 1, 2021

Completion Date

February 1, 2021

Last Updated

July 23, 2020

Enrollment

164

ESTIMATED participants

Conditions

Pain, Postoperative

Interventions

DMTS

DRUG

Placebo

DRUG

Contacts

James Song, MS, MBA

CONTACT

408-501-1800 jsong@teikokuusa.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluating Efficacy of the Dexmedetomidine Transdermal System for Postoperative Analgesia Following Abdominoplasty

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Exclusion Criteria

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