To determine the safety and efficacy of single intra-operative treatment of Botulinum Neurotoxin Serotype E (EB-001) intramuscular (IM) injections into the Rectus Abdominus (RA) in participants undergoing abdominoplasty.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
23
Single botulinum neurotoxin serotype E injection into RA muscles during abdominoplasty surgery.
Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.
Huntington Ambulatory Surgery Center
Pasadena, California, United States
Lotus Clinical Research, LLC
Pasadena, California, United States
Area Under the Curve (AUC) of Participant's Assessment of Pain Using the Numerical Pain Rating Scale (NPRS) at Rest Between 12 and 96 Hours Postsurgery (AUC12-96)
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
Time frame: Every 2 hours from 12 to 96 hours postsurgery
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 96 Hours Postsurgery
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
Time frame: Every 2 hours from 0 to 96 hours postsurgery
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 72 Hours Postsurgery (AUC0-72)
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
Time frame: Every 2 hours from 0 to 72 hours postsurgery
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 48 Hours Postsurgery (AUC0-48)
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
Time frame: Every 2 hours from 0 to 48 hours postsurgery
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 24 Hours Postsurgery (AUC0-24)
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
Time frame: Every 2 hours from 0 to 24 hours postsurgery
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AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 12 and 24 Hours Postsurgery (AUC12-24)
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
Time frame: Every 2 hours from 12 to 24 hours postsurgery
Participants Overall Assessment of Pain Using the NPRS After Discharge
The participant assessed their pain after discharge using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable.
Time frame: Days 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24 and 26
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A)
The participant assessed their pain using the 11-point NPRS-A, after sitting up in the bed unassisted at an angle of approximately ≥ 45 degrees, swinging legs out, putting feet down, standing up, and walking approximately 10 feet, where: 0=no pain to 10=worst pain imaginable.
Time frame: 8, 16, 24, 30, 36, 42, 48, 54, 60, 66, 72.78.84, and 96 hours after surgery; Days 8, 15 and 29 after discharge
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories
The participant assessed their overall pain control in the past 24 hours using the PGA 4-point scale where: 0=poor, 1=fair, 2=good and 3=excellent.
Time frame: Days 5, 8, 15 and 29
Number of Doses of Rescue Medications Used
Time frame: Up to 96 hours postsurgery