Abdominoplasty Clinical Trial
Official title:
A Phase 2 Study to Evaluate Safety and Efficacy of EB-001 Intramuscular (IM) Injections in Reducing Musculoskeletal Pain in Subjects Undergoing Elective Abdominoplasty Surgery
Verified date | August 2019 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 23 |
Est. completion date | July 10, 2018 |
Est. primary completion date | July 10, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 23 Years to 55 Years |
Eligibility |
Inclusion Criteria: 1. Men or women 23 to 55 years of age, inclusive 2. Scheduled to undergo elective abdominoplasty surgery with full length plication from xyphoid to pubis, and removal of skin/fat flap under general anesthesia (endotracheal or otherwise) without liposuction 3. American Society of Anesthesiologist (ASA) Physical Class 1-2. Exclusion Criteria: 1. History of prior major abdominal surgery as judged by the investigator 2. Pre-existing lung disease that could impact participant safety in the opinion of the investigator 3. Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton- Lambert syndrome, or amyotrophic lateral Sclerosis) 4. At high risk of deep vein thrombosis as judged by the investigators determined by a Caprini score of 3 or higher 5. Slow vital capacity that is below 80% of normal value for respective race, age, height, and gender or below 2.5 Liters (L) of absolute volume 6. Pulse oximetry below 95% 7. Body weight less than 50 kg (110 pounds) or a Body Mass Index (BMI) of = 32 8. Reported use of any botulinum toxin within 3 months prior to the date of surgery 9. Use of long acting opioids within 3 days or any opioid medication within 24 hours prior to surgery 10. Aminoglycoside intake within 48 hours prior to or during surgery 11. Participants on anti-depressant or anti-psychotic medications 12. Reported pain score of 2 or more at screening on the 11-point scale numerical pain rating scale-administered after an activity (NPRS-A) following an activity after and walking approximately 10 feet. |
Country | Name | City | State |
---|---|---|---|
United States | Huntington Ambulatory Surgery Center | Pasadena | California |
United States | Lotus Clinical Research, LLC | Pasadena | California |
Lead Sponsor | Collaborator |
---|---|
Allergan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Every 2 hours from 12 to 96 hours postsurgery | |
Secondary | 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. | Every 2 hours from 0 to 96 hours postsurgery | |
Secondary | 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. | Every 2 hours from 0 to 72 hours postsurgery | |
Secondary | 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. | Every 2 hours from 0 to 48 hours postsurgery | |
Secondary | 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. | Every 2 hours from 0 to 24 hours postsurgery | |
Secondary | 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. | Every 2 hours from 12 to 24 hours postsurgery | |
Secondary | 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. | Days 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24 and 26 | |
Secondary | 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. | 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 | |
Secondary | 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. | Days 5, 8, 15 and 29 | |
Secondary | Number of Doses of Rescue Medications Used | Up to 96 hours postsurgery |
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