Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoin… (NCT00813111) | Clinical Trial Compass
TerminatedPhase 3
Phase 3 Study of Local Administration of SKY0402 for Postoperative Analgesia in Subject Undergoing Breast Augmentation
Stopped: Sponsor decision, unrelated to safety
United States136 participantsStarted 2008-11
Plain-language summary
The purpose of this study is to provide a more effective postoperative method of pain control for patients undergoing cosmetic sub-muscular breast augmentation. Appropriate postoperative pain management contributes to faster patient mobilization, shortened hospital stays, and reduced healthcare costs.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Women greater than or equal to 18 years of age at Screening Visit
✓. Postmenopausal, surgically sterile, or willing to use acceptable means of contraception for at least 30 days after surgery including any of the following: hormonal contraceptives (e.g., oral, injectable, implantable starting at least 30 days before study administration), effective double-barrier methods (e.g., condoms with spermicide), intrauterine device, lifestyle with a personal choice of abstinence, nonheterosexual lifestyle, or a strictly monogamous relationship with a partner who has had a vasectomy.
✓. Scheduled to undergo primary, bilateral, cosmetic, sub-muscular, breast augmentation under general anesthesia (endotracheal or otherwise)
✓. American Society of Anesthesiologist (ASA) Physical Class 1-4
✓. Able and willing to comply with all study visits and procedures, and with diary entries through postoperative day 8
✓. Able to speak, read, and understand the language of the informed consent form (ICF), study questionnaires, and other instruments used for collecting subject-reported outcomes, in order to enable accurate and appropriate responses to pain scales and other required study assessments
✓. Willing and capable of providing written informed consent.
Exclusion criteria
✕. Women undergoing reconstructive surgery following mastectomy
✕. Pregnancy, nursing, or planning to become pregnant during the study or within one month after study drug administration.
What they're measuring
1
Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores
. Use of any of the following medications within the times specified before surgery:
✕. long-acting opioids within 3 days.
✕. Any opioid medication within 24 hours.
✕. Concurrent painful physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain that is not strictly related to the surgical site being administered study drug (e.g., significant pain from other joints, chronic neuropathic pain, concurrent abdominal surgery, etc.), which have the potential to confound the postoperative study assessments.
✕. Body weight less than 50 kilograms (110 pounds)
✕. History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics, opioid medication, epinephrine, or sulfites.