Analgesia
Conditions
Keywords
inguinal hernia, hernia, hernia surgery, postoperative pain, herniorrhaphy, multimodal analgesia
Brief summary
This is a Phase 3b, open-label study to assess postoperative opioid use in subjects undergoing unilateral open inguinal herniorrhaphy with intraoperative administration of HTX-011 and a postoperative non-opioid multimodal analgesic (MMA) regimen. The study will be conducted in 2 sequential parts: Part 1 is randomized and Part 2 is Investigator's preference for MMA regimen.
Interventions
DRUGHTX-011
300 mg bupivacaine/9 mg meloxicam
DEVICELuer lock applicator
Applicator for instillation
DRUGIbuprofen
600 mg
DRUGAcetaminophen
1 g
Sponsors
Heron Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
In Part 1, subjects will be randomized to one of the 2 parallel postoperative MMA regimens. In Part 2, the Investigator will select one of the 2 postoperative MMA regimens, based on Investigator and/or subject preference.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is scheduled and medically fit to undergo an elective unilateral open inguinal herniorrhaphy with mesh under deep sedation or general anesthesia; no neuraxial technique (eg, no spinal or epidural). * Has an American Society of Anesthesiologists (ASA) Physical Status of I, II, or III. * Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives.
Exclusion criteria
* Has a planned concurrent surgical procedure (eg, bilateral herniorrhaphy). * Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain. * Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications. * Part 1 only: Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. Part 2 only: Has known or suspected history of persistent opioid use, defined as daily, or almost daily, use of opioids for a period of at least 30 days within the previous 6 months. * Has taken any opioids within 24 hours prior to the scheduled surgery. * Has a known or suspected history of drug abuse, has a positive drug screen on the day of surgery, consumes 3 or more alcoholic drinks every day, or has a recent history of alcohol abuse. * Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Subjects Who do Not Receive an Opioid Prescription Through the Day 15 Visit | Through Day 15 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Who do Not Receive an Opioid Prescription at Discharge | At discharge | Proportion of subjects who do not receive an opioid prescription at discharge (between 2 and 3 hours after surgery on average). |
| Proportion of Subjects Who do Not Receive a Postdischarge Opioid Prescription, Through the Day 15 Visit. | Postdischarge through Day 15 | — |
| Pain Intensity Scores at the Time of Discharge | At discharge | Pain intensity scores were assessed at discharge (between 2 and 3 hours after surgery on average) using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded with activity (NRS-A), sitting up from a resting position. |
| Number of Oxycodone Pills Taken Between Discharge and the Day 15 Visit | Postdischarge through Day 15 | — |
| Mean TSQM-9 Scores | Day 15 plus or minus 2 days | The TSQM-9 contains 9 items which make up the Effectiveness, Convenience, and Global Satisfaction domains; each domain includes 3 items. Scores for each domain were computed by adding the TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100, with higher scores indicating higher satisfaction. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 57 Participants |
| Age, Categorical Between 18 and 65 years | 152 Participants |
| Age, Continuous | 55.1 years STANDARD_DEVIATION 14.71 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 86 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 186 Participants |
| Region of Enrollment United States | 107 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 102 | 0 / 107 |
| other Total, other adverse events | 7 / 102 | 14 / 107 |
| serious Total, serious adverse events | 1 / 102 | 0 / 107 |
Outcome results
None listed