Trial Outcomes & Findings for Phase 2 Herniorrhaphy Study for Opioid Elimination (NCT NCT03695367)
NCT ID: NCT03695367
Last Updated: 2026-03-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
72 hours
Results posted on
2026-03-02
Participant Flow
Participant milestones
| Measure |
Cohort 1: HTX-011 + MMA Regimen
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.
|
Cohort 2: HTX-011 + MMA Regimen + Ketorolac
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
30
|
|
Overall Study
COMPLETED
|
32
|
26
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Cohort 1: HTX-011 + MMA Regimen
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.
|
Cohort 2: HTX-011 + MMA Regimen + Ketorolac
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.
|
|---|---|---|
|
Overall Study
Missed the Day 28 visit.
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
One subject missed the Day 28 visit and one subject missed the Day 10 and Day 28 visits.
|
0
|
2
|
Baseline Characteristics
Phase 2 Herniorrhaphy Study for Opioid Elimination
Baseline characteristics by cohort
| Measure |
Cohort 1: HTX-011 + MMA Regimen
n=33 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.
|
Cohort 2: HTX-011 + MMA Regimen + Ketorolac
n=30 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=41 Participants
|
26 Participants
n=35 Participants
|
56 Participants
n=76 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
7 Participants
n=76 Participants
|
|
Age, Continuous
|
50.9 years
STANDARD_DEVIATION 13.52 • n=41 Participants
|
46.1 years
STANDARD_DEVIATION 14.99 • n=35 Participants
|
48.7 years
STANDARD_DEVIATION 14.33 • n=76 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
4 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=41 Participants
|
26 Participants
n=35 Participants
|
59 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
23 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
40 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
5 Participants
n=76 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=41 Participants
|
26 Participants
n=35 Participants
|
56 Participants
n=76 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=41 Participants
|
30 participants
n=35 Participants
|
63 participants
n=76 Participants
|
PRIMARY outcome
Timeframe: 72 hoursPopulation: Safety Population
Outcome measures
| Measure |
Cohort 1: HTX-011 + MMA Regimen
n=33 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.
|
Cohort 2: HTX-011 + MMA Regimen + Ketorolac
n=30 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.
|
|---|---|---|
|
Percentage of Subjects Receiving no Opioid Rescue
|
30 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Safety Population
Outcome measures
| Measure |
Cohort 1: HTX-011 + MMA Regimen
n=33 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.
|
Cohort 2: HTX-011 + MMA Regimen + Ketorolac
n=30 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.
|
|---|---|---|
|
Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [IV MME])
|
0.59 MME, morphine milligram equivalents
Standard Deviation 2.141
|
1.32 MME, morphine milligram equivalents
Standard Deviation 4.199
|
SECONDARY outcome
Timeframe: 0-24 hours, 24-48 hours, 24-72 hours, 48-72 hoursPopulation: Safety Population
Outcome measures
| Measure |
Cohort 1: HTX-011 + MMA Regimen
n=33 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.
|
Cohort 2: HTX-011 + MMA Regimen + Ketorolac
n=30 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.
|
|---|---|---|
|
Percentge of Subjects Receiving no Opioid Rescue
0-24 hours
|
30 Participants
|
27 Participants
|
|
Percentge of Subjects Receiving no Opioid Rescue
24-48 hours
|
32 Participants
|
29 Participants
|
|
Percentge of Subjects Receiving no Opioid Rescue
24-72 hours
|
32 Participants
|
28 Participants
|
|
Percentge of Subjects Receiving no Opioid Rescue
48-72 hours
|
33 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: Safety Population
Outcome measures
| Measure |
Cohort 1: HTX-011 + MMA Regimen
n=33 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.
|
Cohort 2: HTX-011 + MMA Regimen + Ketorolac
n=30 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.
|
|---|---|---|
|
Percentge of Subjects Receiving no Opioid Rescue
|
28 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Safety Population
Outcome measures
| Measure |
Cohort 1: HTX-011 + MMA Regimen
n=33 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.
|
Cohort 2: HTX-011 + MMA Regimen + Ketorolac
n=30 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.
|
|---|---|---|
|
Percentge of Subjects in Severe Pain With Numeric Rating Scale (NRS-R; Windowed Worst Observation Carried Forward) of Pain Intensity Scores >7 on a Scale of 0-10 at Any Point. NRS-R for Pain Where 0 Equals no Pain and 10 Equals Worst Pain Imaginable.
|
5 Participants
|
6 Participants
|
Adverse Events
Cohort 1: HTX-011 + MMA Regimen
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Cohort 2: HTX-011 + MMA Regimen + Ketorolac
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: HTX-011 + MMA Regimen
n=33 participants at risk
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen.
|
Cohort 2: HTX-011 + MMA Regimen + Ketorolac
n=30 participants at risk
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg via instillation; non-opioid multimodal analgesic (MMA) regimen and IV ketorolac.
|
|---|---|---|
|
Nervous system disorders
Headache
|
3.0%
1/33 • 28 Days.
At each level of summarization (any event, System Organ Class, and Preferred Term), subjects reporting more than one TEAE are counted only once.
|
6.7%
2/30 • 28 Days.
At each level of summarization (any event, System Organ Class, and Preferred Term), subjects reporting more than one TEAE are counted only once.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/33 • 28 Days.
At each level of summarization (any event, System Organ Class, and Preferred Term), subjects reporting more than one TEAE are counted only once.
|
6.7%
2/30 • 28 Days.
At each level of summarization (any event, System Organ Class, and Preferred Term), subjects reporting more than one TEAE are counted only once.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.1%
3/33 • 28 Days.
At each level of summarization (any event, System Organ Class, and Preferred Term), subjects reporting more than one TEAE are counted only once.
|
6.7%
2/30 • 28 Days.
At each level of summarization (any event, System Organ Class, and Preferred Term), subjects reporting more than one TEAE are counted only once.
|
|
Gastrointestinal disorders
Nausea
|
6.1%
2/33 • 28 Days.
At each level of summarization (any event, System Organ Class, and Preferred Term), subjects reporting more than one TEAE are counted only once.
|
10.0%
3/30 • 28 Days.
At each level of summarization (any event, System Organ Class, and Preferred Term), subjects reporting more than one TEAE are counted only once.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/33 • 28 Days.
At each level of summarization (any event, System Organ Class, and Preferred Term), subjects reporting more than one TEAE are counted only once.
|
6.7%
2/30 • 28 Days.
At each level of summarization (any event, System Organ Class, and Preferred Term), subjects reporting more than one TEAE are counted only once.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place