Phase 3b, open-label single-arm study in which all subjects receive HTX-011 as part of a scheduled non-opioid MMA regimen.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
Helen Keller Hospital
Sheffield, Alabama, United States
Phoenix Clinical Research, LLC
Tamarac, Florida, United States
Midwest Clinical Research Center, LLC
Dayton, Ohio, United States
First Surgical Hospital
Bellaire, Texas, United States
Mean Area Under the Curve (AUC) of the Visual Analogue Scale (VAS).
The Visual Analog Scale (VAS) consists of a straight 10-cm line that represents pain ranging from "no pain" to "pain as bad as it could be". Subjects were asked to mark their current pain level on the line.
Time frame: 12 through 48 hours
Mean AUC of VAS Scores.
The Visual Analog Scale (VAS) consists of a straight 10-cm line that represents pain ranging from "no pain" to "pain as bad as it could be". Subjects were asked to mark their current pain level on the line.
Time frame: 72 hours
Mean AUC of the NRS of Pain Intensity at Rest (NRS-R).
Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain". NRS scores are measured at rest.
Time frame: 72 hours
Percentage of Subjects With Severe Pain.
Severe Pain defined as a VAS score ≥7.5 cm.
Time frame: 24 hours, 48 hours, 72 hours
Mean Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [MME]).
Time frame: 72 hours
Percentage of Subjects Who Are Opioid-free
Time frame: 72 Hours to Day 11
Percentage of Subjects Who Are Opioid-free Through 72 Hours Who Remain Opioid-free Through Day 11.
Time frame: 72 hours through Day 11
Median Time to First Opioid Rescue Medication.
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NSAID.
Local anesthetic.
Applicator for instillation.
Dual-acting local anesthetic. Dose 2.
Plano Surgical Hospital
Plano, Texas, United States
Endeavor Clinical Trials, LLC.
San Antonio, Texas, United States
Time frame: Through 72 hours
Percentage of Subjects Who do Not Receive an Opioid Prescription at Discharge.
Time frame: 72 hours
Percentage of Subjects Who do Not Receive an Opioid Prescription Between Discharge and the Day 11 Visit.
Time frame: 72 hours through Day 11
Percentage of Subjects Achieving a Score of "Good" or Better (>1) Pain Control Based on Patient Global Assessment (PGA).
Patient's Global Assessment (PGA) of pain control is a 4-point scale in which subjects rate how well their pain has been controlled (0 = Poor; 1 = Fair; 2 = Good; 3 = Excellent).
Time frame: 24 hours, 48 hours, 72 hours, Day 11
Median Time to First Ambulation Postsurgery.
Time frame: 72 hours
Percentage of Subjects Unable to Participate in Each Rehabilitation Session Because of Pain.
Time frame: 72 hours
Percentage of Subjects Who First Achieve an MPADSS Score ≥9.
Subjects were assessed for readiness for discharge using the Modified Post-Anesthesia Discharge Scoring System (MPADSS) that assesses 5 clinical variables: vital signs, ambulation, nausea/vomiting, pain, and surgical bleeding, each on a 3-point scale of 0, 1, or 2 with 0 being the worst score and 2 being the best score. Subjects with an MPADSS score of 9 or 10 were considered ready for discharge.
Time frame: 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24, hours, 36 hours, 48 hours, 60 hours, 72 hours
Percentage of Subjects Who Are Discharged Home vs to a Skilled Nursing Facility.
Number Analyzed represents Subjects who were discharged home.
Time frame: 72 hours
Mean Overall Benefit of Analgesia Score (OBAS).
Subjects were questioned about their overall benefit of analgesia. Overall benefit of analgesia score (OBAS) assesses current pain at rest, vomiting, itching, sweating, freezing, dizziness, and overall satisfaction with postoperative pain during the previous 24 hours. To calculate the OBAS score, each of the subscale scores (0=minimum; 4=maximum) are summed for a combined OBAS score. Possible scores could range from 0 to 28 with a lower score indicating greater benefit.
Time frame: 24 hours, 48 hours, 72 hours, Day 11
Mean Total TSQM-9 Score
The Treatment Satisfaction Questionnaire for Medication (TSQM-9) contains 9 items assessing Effectiveness, Convenience, and Global Satisfaction domains. Responses to items are rated on a 5-point or 7-point rating scale. Scores for each domain are computed by adding the TSQM items in each domain and then transforming the values in to a composite score ranging from 0 to 100, with higher scores representing higher satisfaction.
Time frame: 72 hours through Day 11
Maximum Concentration (Cmax)
Time frame: 72 hours
Time of Occurrence of Maximum Concentration (Tmax)
Time frame: 72 hours