Trial Outcomes & Findings for Study of Post-Herniorrhaphy Non-opioid MMA Regimens (NCT NCT03907176)
NCT ID: NCT03907176
Last Updated: 2026-06-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
209 participants
Primary outcome timeframe
Through Day 15
Results posted on
2026-06-04
Participant Flow
Participant milestones
| Measure |
HTX-011 + Alternating MMA Regimen
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, alternating (one or the other every 3 hours), while awake.
|
HTX-011 + Concurrent MMA Regimen
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, together every 6 hours, while awake.
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
107
|
|
Overall Study
COMPLETED
|
100
|
107
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Post-Herniorrhaphy Non-opioid MMA Regimens
Baseline characteristics by cohort
| Measure |
HTX-011 + Alternating MMA Regimen
n=102 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, alternating (one or the other every 3 hours), while awake.
|
HTX-011 + Concurrent MMA Regimen
n=107 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, together every 6 hours, while awake.
|
Total
n=209 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
76 Participants
n=9 Participants
|
76 Participants
n=27 Participants
|
152 Participants
n=267 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=9 Participants
|
31 Participants
n=27 Participants
|
57 Participants
n=267 Participants
|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 14.71 • n=9 Participants
|
55.6 years
STANDARD_DEVIATION 14.35 • n=27 Participants
|
55.4 years
STANDARD_DEVIATION 14.47 • n=267 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=9 Participants
|
106 Participants
n=27 Participants
|
205 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
32 Participants
n=9 Participants
|
21 Participants
n=27 Participants
|
53 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
70 Participants
n=9 Participants
|
86 Participants
n=27 Participants
|
156 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
16 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
95 Participants
n=9 Participants
|
91 Participants
n=27 Participants
|
186 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=9 Participants
|
107 participants
n=27 Participants
|
209 participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Through Day 15Outcome measures
| Measure |
HTX-011 + Alternating MMA Regimen
n=102 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, alternating (one or the other every 3 hours), while awake.
|
HTX-011 + Concurrent MMA Regimen
n=107 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, together every 6 hours, while awake.
|
|---|---|---|
|
Proportion of Subjects Who do Not Receive an Opioid Prescription Through the Day 15 Visit
|
95 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: At dischargeProportion of subjects who do not receive an opioid prescription at discharge (between 2 and 3 hours after surgery on average).
Outcome measures
| Measure |
HTX-011 + Alternating MMA Regimen
n=102 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, alternating (one or the other every 3 hours), while awake.
|
HTX-011 + Concurrent MMA Regimen
n=107 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, together every 6 hours, while awake.
|
|---|---|---|
|
Proportion of Subjects Who do Not Receive an Opioid Prescription at Discharge
|
95 Participants
|
98 Participants
|
SECONDARY outcome
Timeframe: Postdischarge through Day 15Outcome measures
| Measure |
HTX-011 + Alternating MMA Regimen
n=102 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, alternating (one or the other every 3 hours), while awake.
|
HTX-011 + Concurrent MMA Regimen
n=107 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, together every 6 hours, while awake.
|
|---|---|---|
|
Proportion of Subjects Who do Not Receive a Postdischarge Opioid Prescription, Through the Day 15 Visit.
|
101 Participants
|
105 Participants
|
SECONDARY outcome
Timeframe: At dischargePopulation: The study was enrolled in 2 parts, NRS-A was not collected in the second part of the study.
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.
Outcome measures
| Measure |
HTX-011 + Alternating MMA Regimen
n=102 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, alternating (one or the other every 3 hours), while awake.
|
HTX-011 + Concurrent MMA Regimen
n=107 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, together every 6 hours, while awake.
|
|---|---|---|
|
Pain Intensity Scores at the Time of Discharge
NRS-R
|
2.3 score on a scale
Standard Deviation 1.51
|
2.6 score on a scale
Standard Deviation 1.89
|
|
Pain Intensity Scores at the Time of Discharge
NRS-A
|
2.7 score on a scale
Standard Deviation 1.84
|
3.2 score on a scale
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: Postdischarge through Day 15Population: Overall Number of Participants Analyzed equals only the subjects taking opioids between discharge and the Day 15 visit.
Outcome measures
| Measure |
HTX-011 + Alternating MMA Regimen
n=2 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, alternating (one or the other every 3 hours), while awake.
|
HTX-011 + Concurrent MMA Regimen
n=6 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, together every 6 hours, while awake.
|
|---|---|---|
|
Number of Oxycodone Pills Taken Between Discharge and the Day 15 Visit
|
11.5 Number of oxycodone 5 mg pills
Interval 10.0 to 13.0
|
12.7 Number of oxycodone 5 mg pills
Interval 5.0 to 22.0
|
SECONDARY outcome
Timeframe: Day 15 plus or minus 2 daysPopulation: TSQM-9 Scores on Regimen 1 missing for 3 subjects for Effectiveness Domain and Global Satisfaction Domain and 7 subject for Convenience Domain.
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.
Outcome measures
| Measure |
HTX-011 + Alternating MMA Regimen
n=102 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, alternating (one or the other every 3 hours), while awake.
|
HTX-011 + Concurrent MMA Regimen
n=107 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, together every 6 hours, while awake.
|
|---|---|---|
|
Mean TSQM-9 Scores
Effectiveness Domain
|
86.8 score on a scale
Standard Deviation 15.89
|
84.1 score on a scale
Standard Deviation 19.33
|
|
Mean TSQM-9 Scores
Convenience Domain
|
89.3 score on a scale
Standard Deviation 12.35
|
88.7 score on a scale
Standard Deviation 12.94
|
|
Mean TSQM-9 Scores
Global Satisfaction Domain
|
87.4 score on a scale
Standard Deviation 14.03
|
85.4 score on a scale
Standard Deviation 16.40
|
Adverse Events
HTX-011 + Alternating MMA Regimen
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
HTX-011 + Concurrent MMA Regimen
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HTX-011 + Alternating MMA Regimen
n=102 participants at risk
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, alternating (one or the other every 3 hours), while awake.
|
HTX-011 + Concurrent MMA Regimen
n=107 participants at risk
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, together every 6 hours, while awake.
|
|---|---|---|
|
Gastrointestinal disorders
Peptic Ulcer Haemorrhage
|
0.98%
1/102 • Number of events 1 • 29 Days.
|
0.00%
0/107 • 29 Days.
|
Other adverse events
| Measure |
HTX-011 + Alternating MMA Regimen
n=102 participants at risk
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, alternating (one or the other every 3 hours), while awake.
|
HTX-011 + Concurrent MMA Regimen
n=107 participants at risk
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen of ibuprofen and acetaminophen, together every 6 hours, while awake.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.9%
5/102 • 29 Days.
|
7.5%
8/107 • 29 Days.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
2/102 • 29 Days.
|
5.6%
6/107 • 29 Days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place