The purpose of this study is to evaluate three dose levels of SKY0402 compared with 105 mg of bupivacaine HCl.
Effective postoperative pain control is a critical element in patient recovery, as the majority of patients may experience significant pain, particularly in the first few days following surgery. Appropriate postoperative pain management contributes to improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
98
Bupivacaine HCl given during hernia repair
SKY0402 given during hernia repair
Arcadia Methodist Hospital
Arcadia, California, United States
Saddleback Valley Outpatient Surgery
Laguna Hills, California, United States
Huntington Memorial Hospital
Pasadena, California, United States
St. Luke's Roosevelt Hosptial Center
New York, New York, United States
Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores From 0 Through 72 Hours
The subject's pain intensity was to be assessed with activity (NRS-A), after the subject had moved himself from a supine position in bed to a sitting up position at the edge of the bed. The subject was to respond to the following question: "On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain did you have while sitting up?"
Time frame: 0 to 72 hours
Number of Participants With Adverse Events Through 96 Hours or Serious Adverse Events Through 30 Days
Time frame: Up to 30 days
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Memorial Hermann Healthcare System
Houston, Texas, United States
Kirby Outpatient Surgical Center
Houston, Texas, United States