Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia
Sponsor
Heron Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT03015532
Collaborator
(none)
285
24
8
16
11.9
0.7
Study Details
Study Description
Brief Summary
This is a Phase 2b, randomized, double-blind, saline placebo- and active-controlled, multicenter study in subjects undergoing primary unilateral total knee arthroplasty (TKA) to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of HTX-011 administered via infiltration to the surgical site.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
285 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2b, Randomized, Double-Blind, Saline Placebo- and Active-Controlled, Multicenter Study of HTX-011 Via Infiltration for Postoperative Analgesia in Subjects Undergoing Total Knee Arthroplasty
Actual Study Start Date
:
Jan 13, 2017
Actual Primary Completion Date
:
Apr 20, 2018
Actual Study Completion Date
:
May 16, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1, Group 1: HTX-011 HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation |
Drug: HTX-011
HTX-011 (bupivacaine/meloxicam), via instillation
|
| Experimental: Cohort 1, Group 2: HTX-011 HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination) |
Drug: HTX-011
HTX-011 (bupivacaine/meloxicam), via instillation
|
| Placebo Comparator: Cohort 1, Group 3: Saline Placebo Saline placebo via injection |
Drug: Saline Placebo
Saline placebo via injection
|
| Active Comparator: Cohort 1, Group 4: Bupivacaine HCI Bupivacaine HCl without epinephrine, 125 mg via injection |
Drug: Bupivicaine HCl
Bupivacaine HCl without epinephrine
|
| Experimental: Cohort 2, Group 1: HTX-011 HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via instillation |
Drug: HTX-011
HTX-011 (bupivacaine/meloxicam), via instillation
|
| Experimental: Cohort 2, Group 2: HTX-011 + Ropivacaine HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection |
Drug: HTX-011
HTX-011 (bupivacaine/meloxicam), via instillation
Drug: Ropivacaine
Ropivacaine, via injection
|
| Placebo Comparator: Cohort 2, Group 3: Saline Placebo Saline placebo via injection |
Drug: Saline Placebo
Saline placebo via injection
|
| Active Comparator: Cohort 2, Group 4: Bupivacaine HCI Bupivacaine HCl without epinephrine, 125 mg via injection |
Drug: Bupivicaine HCl
Bupivacaine HCl without epinephrine
|
Outcome Measures
Primary Outcome Measures
- Mean Area Under the Curve (AUC) of the NRS-R (Windowed Worst Observation Carried Forward) Pain Intensity Scores [48 hours]
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 imaginable". NRS scores are recorded at rest (NRS-R).
Secondary Outcome Measures
- Mean Area Under the Curve (AUC) of the NRS-R (Windowed Worst Observation Carried Forward) Pain Intensity Scores [72 hours]
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 imaginable". NRS scores are recorded at rest (NRS-R).
- Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) [72 hours]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Is scheduled to undergo primary unilateral TKA under general anesthesia.
-
Has not previously undergone TKA in either knee.
-
Has an American Society of Anesthesiologists Physical Status of I, II, or III.
-
Is able to demonstrate motor function by performing a timed 20-meter walk unassisted, but with the optional use of a 4-legged walker for balance.
-
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 TKA).
-
Has a pre-existing concurrent acute or chronic painful/restrictive physical condition that may require analgesic treatment in the postoperative period for pain.
-
Has a contraindication or a known or suspected history of hypersensitivity or idiosyncratic reaction to required study medications.
-
Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.
-
Has taken NSAIDs within 10 days prior to the scheduled surgery.
-
Has taken opioids within 24 hours prior to the scheduled surgery (3 days for long-acting).
-
Has been administered bupivacaine within 5 days prior to the scheduled surgery.
-
Has initiated treatment with medications within 1 month prior to study drug administration that can impact pain control.
-
Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug.
-
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.
-
Has a known history of Hepatitis B, human immunodeficiency virus (HIV), or active Hepatitis C.
-
Has uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments.
-
Has any chronic neuromuscular deficit of either femoral nerve function or thigh musculature. Has any chronic condition or disease that would compromise neurological or vascular assessments.
-
Had a malignancy in the last year, with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
-
Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse.
-
Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.
-
Has undergone 3 or more surgeries within 12 months.
-
Has a body mass index (BMI) >38 kg/m2.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mobile | Alabama | United States | 36608 | |
| 2 | Sheffield | Alabama | United States | 35660 | |
| 3 | Phoenix | Arizona | United States | 85015 | |
| 4 | Phoenix | Arizona | United States | 85023 | |
| 5 | La Jolla | California | United States | 92037 | |
| 6 | Riverside | California | United States | 92503 | |
| 7 | San Diego | California | United States | 92103 | |
| 8 | Miami | Florida | United States | 33136 | |
| 9 | Miami | Florida | United States | 33143 | |
| 10 | Miami | Florida | United States | 33155 | |
| 11 | Tamarac | Florida | United States | 33321 | |
| 12 | Las Vegas | Nevada | United States | 89109 | |
| 13 | Columbus | Ohio | United States | 43203 | |
| 14 | Columbus | Ohio | United States | 43210 | |
| 15 | Dayton | Ohio | United States | 45417 | |
| 16 | Bellaire | Texas | United States | 77401 | |
| 17 | Houston | Texas | United States | 77004 | |
| 18 | Houston | Texas | United States | 77027 | |
| 19 | Houston | Texas | United States | 77043 | |
| 20 | Plano | Texas | United States | 75093 | |
| 21 | San Antonio | Texas | United States | 78209 | |
| 22 | San Antonio | Texas | United States | 78229 | |
| 23 | San Antonio | Texas | United States | 78240 | |
| 24 | Webster | Texas | United States | 77598 |
Sponsors and Collaborators
- Heron Therapeutics
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Heron Therapeutics
ClinicalTrials.gov Identifier:
NCT03015532
Other Study ID Numbers:
- HTX-011-209
First Posted:
Jan 10, 2017
Last Update Posted:
Oct 27, 2021
Last Verified:
Sep 1, 2021
Keywords provided by Heron Therapeutics
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Cohort 1, Group 1: HTX-011 | Cohort 1, Group 2: HTX-011 | Cohort 1, Group 3: Saline Placebo | Cohort 1, Group 4: Bupivacaine HCI | Cohort 2, Group 1: HTX-011 | Cohort 2, Group 2: HTX-011 + Ropivacaine | Cohort 2, Group 3: Saline Placebo | Cohort 2, Group 4: Bupivacaine HCI |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation. | HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination). | Saline placebo via injection. | Bupivacaine HCl without epinephrine, 125 mg via injection. | HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation. | HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection. | Saline placebo via injection. | Bupivacaine HCl without epinephrine, 125 mg via injection. |
| Period Title: Overall Study | ||||||||
| STARTED | 20 | 22 | 11 | 10 | 58 | 56 | 53 | 55 |
| COMPLETED | 20 | 22 | 11 | 10 | 58 | 54 | 51 | 55 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 0 |
Baseline Characteristics
| Arm/Group Title | Cohort 1, Group 1: HTX-011 | Cohort 1, Group 2: HTX-011 | Cohort 1, Group 3: Saline Placebo | Cohort 1, Group 4: Bupivacaine HCI | Cohort 2, Group 1: HTX-011 | Cohort 2, Group 2: HTX-011 + Ropivacaine | Cohort 2, Group 3: Saline Placebo | Cohort 2, Group 4: Bupivacaine HCI | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation. | HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination). | Saline placebo via injection. | Bupivacaine HCl without epinephrine, 125 mg via injection. | HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation. | HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection. | Saline placebo via injection. | Bupivacaine HCl without epinephrine, 125 mg via injection. | Total of all reporting groups |
| Overall Participants | 20 | 22 | 11 | 10 | 58 | 56 | 53 | 55 | 285 |
| Age (Count of Participants) | |||||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
12
60%
|
17
77.3%
|
5
45.5%
|
4
40%
|
31
53.4%
|
34
60.7%
|
36
67.9%
|
38
69.1%
|
177
62.1%
|
| >=65 years |
8
40%
|
5
22.7%
|
6
54.5%
|
6
60%
|
27
46.6%
|
22
39.3%
|
17
32.1%
|
17
30.9%
|
108
37.9%
|
| Age (years) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [years] |
62.1
(7.52)
|
58.6
(7.44)
|
64.9
(4.64)
|
65.3
(11.62)
|
62.5
(8.63)
|
63.2
(9.36)
|
61.5
(8.31)
|
61.4
(9.37)
|
62.1
(8.71)
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
13
65%
|
9
40.9%
|
7
63.6%
|
5
50%
|
26
44.8%
|
27
48.2%
|
25
47.2%
|
35
63.6%
|
147
51.6%
|
| Male |
7
35%
|
13
59.1%
|
4
36.4%
|
5
50%
|
32
55.2%
|
29
51.8%
|
28
52.8%
|
20
36.4%
|
138
48.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||||||
| Hispanic or Latino |
7
35%
|
10
45.5%
|
3
27.3%
|
1
10%
|
9
15.5%
|
16
28.6%
|
12
22.6%
|
16
29.1%
|
74
26%
|
| Not Hispanic or Latino |
13
65%
|
12
54.5%
|
8
72.7%
|
9
90%
|
49
84.5%
|
40
71.4%
|
41
77.4%
|
39
70.9%
|
211
74%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||||||
| American Indian or Alaska Native |
0
0%
|
1
4.5%
|
0
0%
|
0
0%
|
1
1.7%
|
1
1.8%
|
0
0%
|
0
0%
|
3
1.1%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
1.8%
|
0
0%
|
1
1.8%
|
2
0.7%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
5
25%
|
3
13.6%
|
2
18.2%
|
3
30%
|
6
10.3%
|
5
8.9%
|
8
15.1%
|
7
12.7%
|
39
13.7%
|
| White |
15
75%
|
18
81.8%
|
9
81.8%
|
7
70%
|
51
87.9%
|
49
87.5%
|
45
84.9%
|
47
85.5%
|
241
84.6%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||||||||
| United States |
20
100%
|
22
100%
|
11
100%
|
10
100%
|
58
100%
|
56
100%
|
53
100%
|
55
100%
|
285
100%
|
Outcome Measures
| Title | Mean Area Under the Curve (AUC) of the NRS-R (Windowed Worst Observation Carried Forward) Pain Intensity Scores |
|---|---|
| Description | 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 imaginable". NRS scores are recorded at rest (NRS-R). |
| Time Frame | 48 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | Cohort 1, Group 1: HTX-011 | Cohort 1, Group 2: HTX-011 | Cohort 1, Group 3: Saline Placebo | Cohort 1, Group 4: Bupivacaine HCI | Cohort 2, Group 1: HTX-011 | Cohort 2, Group 2: HTX-011 + Ropivacaine | Cohort 2, Group 3: Saline Placebo | Cohort 2, Group 4: Bupivacaine HCI |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation. | HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination). | Saline placebo via injection. | Bupivacaine HCl without epinephrine, 125 mg via injection. | HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation. | HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection. | Saline placebo via injection. | Bupivacaine HCl without epinephrine, 125 mg via injection. |
| Measure Participants | 20 | 22 | 11 | 10 | 58 | 56 | 53 | 55 |
| Mean (Standard Deviation) [pain intensity score*hr] |
386.12
(82.930)
|
391.56
(84.450)
|
405.82
(97.549)
|
347.56
(103.422)
|
322.08
(99.669)
|
307.25
(127.674)
|
396.36
(77.468)
|
352.74
(100.887)
|
| Title | Mean Area Under the Curve (AUC) of the NRS-R (Windowed Worst Observation Carried Forward) Pain Intensity Scores |
|---|---|
| Description | 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 imaginable". NRS scores are recorded at rest (NRS-R). |
| Time Frame | 72 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | Cohort 1, Group 1: HTX-011 | Cohort 1, Group 2: HTX-011 | Cohort 1, Group 3: Saline Placebo | Cohort 1, Group 4: Bupivacaine HCI | Cohort 2, Group 1: HTX-011 | Cohort 2, Group 2: HTX-011 + Ropivacaine | Cohort 2, Group 3: Saline Placebo | Cohort 2, Group 4: Bupivacaine HCI |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation. | HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination). | Saline placebo via injection. | Bupivacaine HCl without epinephrine, 125 mg via injection. | HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation. | HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection. | Saline placebo via injection. | Bupivacaine HCl without epinephrine, 125 mg via injection. |
| Measure Participants | 20 | 22 | 11 | 10 | 58 | 56 | 53 | 55 |
| Mean (Standard Deviation) [pain intensity score*hr] |
543.14
(142.566)
|
560.85
(136.099)
|
576.44
(150.815)
|
468.58
(179.687)
|
471.19
(149.443)
|
452.54
(194.095)
|
577.93
(125.102)
|
516.93
(152.512)
|
| Title | Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) |
|---|---|
| Description | |
| Time Frame | 72 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | Cohort 1, Group 1: HTX-011 | Cohort 1, Group 2: HTX-011 | Cohort 1, Group 3: Saline Placebo | Cohort 1, Group 4: Bupivacaine HCI | Cohort 2, Group 1: HTX-011 | Cohort 2, Group 2: HTX-011 + Ropivacaine | Cohort 2, Group 3: Saline Placebo | Cohort 2, Group 4: Bupivacaine HCI |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation. | HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination). | Saline placebo via injection. | Bupivacaine HCl without epinephrine, 125 mg via injection. | HTX-011, 400 mg/12 mg via instillation. | HTX-011, 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection. | Saline placebo via injection. | Bupivacaine HCl without epinephrine, 125 mg via injection. |
| Measure Participants | 20 | 22 | 11 | 10 | 58 | 56 | 53 | 55 |
| Mean (Standard Deviation) [morphine milligram equivalent (MME)] |
65.53
(31.615)
|
66.86
(31.154)
|
70.41
(18.057)
|
60.70
(29.903)
|
64.39
(27.889)
|
60.32
(34.949)
|
73.55
(34.448)
|
68.35
(29.169)
|
Adverse Events
| Time Frame | 28 Days. | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Subjects reporting more than one TEAE are counted only once. | |||||||||||||||
| Arm/Group Title | Cohort 1, Group 1: HTX-011 | Cohort 1, Group 2: HTX-011 | Cohort 1, Group 3: Saline Placebo | Cohort 1, Group 4: Bupivacaine HCI | Cohort 2, Group 1: HTX-011 | Cohort 2, Group 2: HTX-011 + Ropivacaine | Cohort 2, Group 3: Saline Placebo | Cohort 2, Group 4: Bupivacaine HCI | ||||||||
| Arm/Group Description | HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation. | HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation(combination). | Saline placebo via injection. | Bupivacaine HCl without epinephrine, 125 mg via injection. | HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation. | HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection. | Saline placebo via injection. | Bupivacaine HCl without epinephrine, 125 mg via injection. | ||||||||
All Cause Mortality |
||||||||||||||||
| Cohort 1, Group 1: HTX-011 | Cohort 1, Group 2: HTX-011 | Cohort 1, Group 3: Saline Placebo | Cohort 1, Group 4: Bupivacaine HCI | Cohort 2, Group 1: HTX-011 | Cohort 2, Group 2: HTX-011 + Ropivacaine | Cohort 2, Group 3: Saline Placebo | Cohort 2, Group 4: Bupivacaine HCI | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 0/58 (0%) | 0/56 (0%) | 0/53 (0%) | 0/55 (0%) | ||||||||
Serious Adverse Events |
||||||||||||||||
| Cohort 1, Group 1: HTX-011 | Cohort 1, Group 2: HTX-011 | Cohort 1, Group 3: Saline Placebo | Cohort 1, Group 4: Bupivacaine HCI | Cohort 2, Group 1: HTX-011 | Cohort 2, Group 2: HTX-011 + Ropivacaine | Cohort 2, Group 3: Saline Placebo | Cohort 2, Group 4: Bupivacaine HCI | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 2/22 (9.1%) | 0/11 (0%) | 1/10 (10%) | 1/58 (1.7%) | 4/56 (7.1%) | 3/53 (5.7%) | 2/55 (3.6%) | ||||||||
| Cardiac disorders | ||||||||||||||||
| Atrial fibrillation | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 1/58 (1.7%) | 0/56 (0%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Hepatobiliary disorders | ||||||||||||||||
| Cholecystitis acute | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 0/58 (0%) | 0/56 (0%) | 1/53 (1.9%) | 0/55 (0%) | ||||||||
| Infections and infestations | ||||||||||||||||
| Post procedural cellulitis | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 0/58 (0%) | 1/56 (1.8%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||
| Post procedural haematoma | 0/20 (0%) | 1/22 (4.5%) | 0/11 (0%) | 0/10 (0%) | 0/58 (0%) | 0/56 (0%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Metabolism and nutrition disorders | ||||||||||||||||
| Hyponatraemia | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 0/58 (0%) | 0/56 (0%) | 1/53 (1.9%) | 0/55 (0%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| Syncope | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 1/10 (10%) | 0/58 (0%) | 0/56 (0%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Renal and urinary disorders | ||||||||||||||||
| Urinary retention | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 0/58 (0%) | 1/56 (1.8%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Hypoxia | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 0/58 (0%) | 0/56 (0%) | 0/53 (0%) | 1/55 (1.8%) | ||||||||
| Pulmonary embolism | 0/20 (0%) | 1/22 (4.5%) | 0/11 (0%) | 0/10 (0%) | 1/58 (1.7%) | 1/56 (1.8%) | 0/53 (0%) | 1/55 (1.8%) | ||||||||
| Respiratory failure | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 0/58 (0%) | 1/56 (1.8%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Respiratory depression | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 0/58 (0%) | 1/56 (1.8%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Vascular disorders | ||||||||||||||||
| Haematoma | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 0/58 (0%) | 0/56 (0%) | 1/53 (1.9%) | 0/55 (0%) | ||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| Cohort 1, Group 1: HTX-011 | Cohort 1, Group 2: HTX-011 | Cohort 1, Group 3: Saline Placebo | Cohort 1, Group 4: Bupivacaine HCI | Cohort 2, Group 1: HTX-011 | Cohort 2, Group 2: HTX-011 + Ropivacaine | Cohort 2, Group 3: Saline Placebo | Cohort 2, Group 4: Bupivacaine HCI | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 19/20 (95%) | 22/22 (100%) | 11/11 (100%) | 10/10 (100%) | 55/58 (94.8%) | 50/56 (89.3%) | 50/53 (94.3%) | 49/55 (89.1%) | ||||||||
| Blood and lymphatic system disorders | ||||||||||||||||
| Leukocytosis | 1/20 (5%) | 5/22 (22.7%) | 2/11 (18.2%) | 1/10 (10%) | 4/58 (6.9%) | 6/56 (10.7%) | 0/53 (0%) | 1/55 (1.8%) | ||||||||
| Anaemia | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 3/58 (5.2%) | 1/56 (1.8%) | 1/53 (1.9%) | 0/55 (0%) | ||||||||
| Thrombocytosis | 1/20 (5%) | 0/22 (0%) | 1/11 (9.1%) | 0/10 (0%) | 1/58 (1.7%) | 1/56 (1.8%) | 1/53 (1.9%) | 1/55 (1.8%) | ||||||||
| Cardiac disorders | ||||||||||||||||
| Tachycardia | 4/20 (20%) | 4/22 (18.2%) | 1/11 (9.1%) | 0/10 (0%) | 9/58 (15.5%) | 9/56 (16.1%) | 11/53 (20.8%) | 6/55 (10.9%) | ||||||||
| Supraventricular tachycardia | 0/20 (0%) | 1/22 (4.5%) | 1/11 (9.1%) | 0/10 (0%) | 2/58 (3.4%) | 0/56 (0%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Atrial fibrillation | 0/20 (0%) | 0/22 (0%) | 1/11 (9.1%) | 0/10 (0%) | 0/58 (0%) | 0/56 (0%) | 1/53 (1.9%) | 0/55 (0%) | ||||||||
| Sinus tachycardia | 1/20 (5%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 0/58 (0%) | 0/56 (0%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| Nausea | 14/20 (70%) | 16/22 (72.7%) | 6/11 (54.5%) | 4/10 (40%) | 29/58 (50%) | 30/56 (53.6%) | 25/53 (47.2%) | 30/55 (54.5%) | ||||||||
| Constipation | 8/20 (40%) | 10/22 (45.5%) | 2/11 (18.2%) | 3/10 (30%) | 14/58 (24.1%) | 21/56 (37.5%) | 12/53 (22.6%) | 18/55 (32.7%) | ||||||||
| Vomiting | 7/20 (35%) | 6/22 (27.3%) | 4/11 (36.4%) | 2/10 (20%) | 15/58 (25.9%) | 14/56 (25%) | 10/53 (18.9%) | 15/55 (27.3%) | ||||||||
| Dyspepsia | 0/20 (0%) | 1/22 (4.5%) | 0/11 (0%) | 0/10 (0%) | 2/58 (3.4%) | 2/56 (3.6%) | 3/53 (5.7%) | 3/55 (5.5%) | ||||||||
| Gastrooesophageal reflux disease | 0/20 (0%) | 1/22 (4.5%) | 0/11 (0%) | 1/10 (10%) | 2/58 (3.4%) | 0/56 (0%) | 1/53 (1.9%) | 0/55 (0%) | ||||||||
| Dry mouth | 3/20 (15%) | 1/22 (4.5%) | 1/11 (9.1%) | 1/10 (10%) | 0/58 (0%) | 0/56 (0%) | 0/53 (0%) | 1/55 (1.8%) | ||||||||
| Dysphagia | 1/20 (5%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 0/58 (0%) | 0/56 (0%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Retching | 1/20 (5%) | 0/22 (0%) | 1/11 (9.1%) | 0/10 (0%) | 0/58 (0%) | 0/56 (0%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| General disorders | ||||||||||||||||
| Pyrexia | 1/20 (5%) | 5/22 (22.7%) | 0/11 (0%) | 2/10 (20%) | 8/58 (13.8%) | 8/56 (14.3%) | 2/53 (3.8%) | 8/55 (14.5%) | ||||||||
| Hyperthermia | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 2/58 (3.4%) | 3/56 (5.4%) | 2/53 (3.8%) | 0/55 (0%) | ||||||||
| Medical device site reaction | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 2/10 (20%) | 3/58 (5.2%) | 2/56 (3.6%) | 1/53 (1.9%) | 1/55 (1.8%) | ||||||||
| Feeling cold | 1/20 (5%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 2/58 (3.4%) | 1/56 (1.8%) | 1/53 (1.9%) | 0/55 (0%) | ||||||||
| Chills | 1/20 (5%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 1/58 (1.7%) | 1/56 (1.8%) | 1/53 (1.9%) | 1/55 (1.8%) | ||||||||
| Oedema peripheral | 2/20 (10%) | 3/22 (13.6%) | 0/11 (0%) | 1/10 (10%) | 1/58 (1.7%) | 0/56 (0%) | 3/53 (5.7%) | 1/55 (1.8%) | ||||||||
| Peripheral swelling | 0/20 (0%) | 2/22 (9.1%) | 0/11 (0%) | 0/10 (0%) | 1/58 (1.7%) | 0/56 (0%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Asthenia | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 1/10 (10%) | 0/58 (0%) | 0/56 (0%) | 0/53 (0%) | 1/55 (1.8%) | ||||||||
| Pain | 2/20 (10%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 0/58 (0%) | 0/56 (0%) | 1/53 (1.9%) | 0/55 (0%) | ||||||||
| Inflammation | 1/20 (5%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 0/58 (0%) | 0/56 (0%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Fatigue | 0/20 (0%) | 0/22 (0%) | 1/11 (9.1%) | 0/10 (0%) | 0/58 (0%) | 0/56 (0%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Infections and infestations | ||||||||||||||||
| Urinary tract infection | 0/20 (0%) | 1/22 (4.5%) | 1/11 (9.1%) | 0/10 (0%) | 0/58 (0%) | 1/56 (1.8%) | 1/53 (1.9%) | 1/55 (1.8%) | ||||||||
| Oral herpes | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 1/10 (10%) | 0/58 (0%) | 0/56 (0%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||
| Post procedural complication | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 4/58 (6.9%) | 0/56 (0%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Contusion | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 2/58 (3.4%) | 1/56 (1.8%) | 1/53 (1.9%) | 3/55 (5.5%) | ||||||||
| Incision site erythema | 0/20 (0%) | 0/22 (0%) | 1/11 (9.1%) | 0/10 (0%) | 2/58 (3.4%) | 1/56 (1.8%) | 2/53 (3.8%) | 0/55 (0%) | ||||||||
| Postoperative fever | 1/20 (5%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 2/58 (3.4%) | 1/56 (1.8%) | 1/53 (1.9%) | 0/55 (0%) | ||||||||
| Anaemia postoperative | 4/20 (20%) | 3/22 (13.6%) | 2/11 (18.2%) | 1/10 (10%) | 0/58 (0%) | 2/56 (3.6%) | 5/53 (9.4%) | 1/55 (1.8%) | ||||||||
| Incision site oedema | 0/20 (0%) | 0/22 (0%) | 1/11 (9.1%) | 0/10 (0%) | 0/58 (0%) | 0/56 (0%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Wound dehiscence | 0/20 (0%) | 0/22 (0%) | 1/11 (9.1%) | 0/10 (0%) | 0/58 (0%) | 0/56 (0%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Investigations | ||||||||||||||||
| Gamma-glutamyltransferase increased | 0/20 (0%) | 0/22 (0%) | 1/11 (9.1%) | 0/10 (0%) | 0/58 (0%) | 2/56 (3.6%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Metabolism and nutrition disorders | ||||||||||||||||
| Hypokalaemia | 2/20 (10%) | 1/22 (4.5%) | 3/11 (27.3%) | 1/10 (10%) | 3/58 (5.2%) | 6/56 (10.7%) | 4/53 (7.5%) | 6/55 (10.9%) | ||||||||
| Hyperglycaemia | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 2/10 (20%) | 1/58 (1.7%) | 2/56 (3.6%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Hyponatraemia | 1/20 (5%) | 4/22 (18.2%) | 1/11 (9.1%) | 2/10 (20%) | 1/58 (1.7%) | 0/56 (0%) | 0/53 (0%) | 2/55 (3.6%) | ||||||||
| Hyperkalaemia | 1/20 (5%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 0/58 (0%) | 0/56 (0%) | 1/53 (1.9%) | 0/55 (0%) | ||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Arthralgia | 1/20 (5%) | 1/22 (4.5%) | 1/11 (9.1%) | 0/10 (0%) | 0/58 (0%) | 1/56 (1.8%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Pain in extremity | 0/20 (0%) | 2/22 (9.1%) | 1/11 (9.1%) | 0/10 (0%) | 0/58 (0%) | 0/56 (0%) | 1/53 (1.9%) | 1/55 (1.8%) | ||||||||
| Joint swelling | 1/20 (5%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 0/58 (0%) | 0/56 (0%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Muscle spasms | 3/20 (15%) | 1/22 (4.5%) | 1/11 (9.1%) | 1/10 (10%) | 7/58 (12.1%) | 3/56 (5.4%) | 9/53 (17%) | 4/55 (7.3%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| Dizziness | 5/20 (25%) | 5/22 (22.7%) | 4/11 (36.4%) | 3/10 (30%) | 9/58 (15.5%) | 8/56 (14.3%) | 9/53 (17%) | 8/55 (14.5%) | ||||||||
| Headache | 3/20 (15%) | 3/22 (13.6%) | 2/11 (18.2%) | 1/10 (10%) | 4/58 (6.9%) | 2/56 (3.6%) | 0/53 (0%) | 4/55 (7.3%) | ||||||||
| Lethargy | 1/20 (5%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 0/58 (0%) | 1/56 (1.8%) | 0/53 (0%) | 1/55 (1.8%) | ||||||||
| Paraesthesia | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 1/10 (10%) | 0/58 (0%) | 0/56 (0%) | 1/53 (1.9%) | 0/55 (0%) | ||||||||
| Sciatica | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 1/10 (10%) | 0/58 (0%) | 0/56 (0%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Psychiatric disorders | ||||||||||||||||
| Insomnia | 0/20 (0%) | 3/22 (13.6%) | 0/11 (0%) | 0/10 (0%) | 1/58 (1.7%) | 6/56 (10.7%) | 6/53 (11.3%) | 0/55 (0%) | ||||||||
| Anxiety | 0/20 (0%) | 1/22 (4.5%) | 0/11 (0%) | 1/10 (10%) | 1/58 (1.7%) | 4/56 (7.1%) | 4/53 (7.5%) | 0/55 (0%) | ||||||||
| Confusional state | 0/20 (0%) | 0/22 (0%) | 0/11 (0%) | 1/10 (10%) | 0/58 (0%) | 0/56 (0%) | 1/53 (1.9%) | 1/55 (1.8%) | ||||||||
| Renal and urinary disorders | ||||||||||||||||
| Urinary retention | 0/20 (0%) | 1/22 (4.5%) | 1/11 (9.1%) | 0/10 (0%) | 4/58 (6.9%) | 4/56 (7.1%) | 6/53 (11.3%) | 2/55 (3.6%) | ||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Dyspnoea | 0/20 (0%) | 0/22 (0%) | 1/11 (9.1%) | 0/10 (0%) | 0/58 (0%) | 1/56 (1.8%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Dysphonia | 0/20 (0%) | 0/22 (0%) | 1/11 (9.1%) | 0/10 (0%) | 0/58 (0%) | 0/56 (0%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Laryngospasm | 0/20 (0%) | 0/22 (0%) | 1/11 (9.1%) | 0/10 (0%) | 0/58 (0%) | 0/56 (0%) | 0/53 (0%) | 0/55 (0%) | ||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| Pruritus | 2/20 (10%) | 1/22 (4.5%) | 0/11 (0%) | 2/10 (20%) | 4/58 (6.9%) | 4/56 (7.1%) | 1/53 (1.9%) | 3/55 (5.5%) | ||||||||
| Pruritus generalised | 2/20 (10%) | 2/22 (9.1%) | 1/11 (9.1%) | 2/10 (20%) | 5/58 (8.6%) | 2/56 (3.6%) | 5/53 (9.4%) | 0/55 (0%) | ||||||||
| Erythema | 1/20 (5%) | 1/22 (4.5%) | 0/11 (0%) | 0/10 (0%) | 2/58 (3.4%) | 1/56 (1.8%) | 1/53 (1.9%) | 0/55 (0%) | ||||||||
| Hyperhidrosis | 4/20 (20%) | 2/22 (9.1%) | 1/11 (9.1%) | 0/10 (0%) | 3/58 (5.2%) | 0/56 (0%) | 2/53 (3.8%) | 0/55 (0%) | ||||||||
| Surgical and medical procedures | ||||||||||||||||
| Wound drainage | 1/20 (5%) | 0/22 (0%) | 0/11 (0%) | 0/10 (0%) | 0/58 (0%) | 0/56 (0%) | 1/53 (1.9%) | 0/55 (0%) | ||||||||
| Vascular disorders | ||||||||||||||||
| Hypertension | 2/20 (10%) | 3/22 (13.6%) | 1/11 (9.1%) | 4/10 (40%) | 11/58 (19%) | 8/56 (14.3%) | 8/53 (15.1%) | 7/55 (12.7%) | ||||||||
| Hypotension | 0/20 (0%) | 0/22 (0%) | 1/11 (9.1%) | 0/10 (0%) | 3/58 (5.2%) | 2/56 (3.6%) | 2/53 (3.8%) | 1/55 (1.8%) | ||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Vice President, Clinical Operations |
|---|---|
| Organization | Heron Therapeutics, Inc. |
| Phone | 858-251-7232 |
| svisonneau@herontx.com |
Responsible Party:
Heron Therapeutics
ClinicalTrials.gov Identifier:
NCT03015532
Other Study ID Numbers:
- HTX-011-209
First Posted:
Jan 10, 2017
Last Update Posted:
Oct 27, 2021
Last Verified:
Sep 1, 2021