Analgesia, Postsurgical Pain, Prostatectomy
Conditions
Keywords
TAP, robot-assisted prostatectomy
Brief summary
The purpose of the study is to assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy.
Detailed description
Assess the safety and efficacy of EXPAREL when administered via infiltration into the transversus abdominis plane (TAP) to provide prolonged postsurgical analgesia in men undergoing robot-assisted laparoscopic prostatectomy. The primary endpoint is the duration of abdominal analgesia from the infiltration into the TAP as measured by the time to the subject's first postsurgical opioid administration.
Interventions
DRUGEXPAREL 20 mL
EXPAREL 266 mg (undiluted)
DRUGEXPAREL 40 mL
EXPAREL 266 mg diluted with preservative-free 0.9% normal saline to 40 mL.
Sponsors
Pacira Pharmaceuticals, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* male subjects, aged 18-75. * American Society of Anesthesiology (ASA) physical status 1-3. * Undergoing robot-assisted laparoscopic prostatectomy performed by a single surgeon (Ingolf Tuerk, MD). * Subjects must be physically and mentally able to participate in the study and complete all study assessments. * Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the TAP infiltration.
Exclusion criteria
* Demonstrated hypersensitivity or idiosyncratic reactions to amide-type local anesthetics. * Inability to tolerate oxycodone with acetaminophen (e.g. Percocet). * Any subject whose anatomy or surgical procedure in the opinion of the Investigator might preclude the potential successful performance of a TAP. * Any subject who in the opinion of the Investigator might be harmed or be a poor candidate for participation in the study. * Subjects who have received any investigational drug within 30 days prior to study drug administration or planned administration of another investigational product or procedure during their participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Duration of Abdominal Analgesia From Infiltration Into the TAP | First postsurgical administration of an opioid |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Reported Postsurgical Pain | 1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP | 11-point numeric rating scale (NRS) (0-10, where 0=no pain, 10=worst possible pain) |
| Physician/Healthcare Professional Assessed Postsurgical Pain | 1, 2, 6, 12, 24 hours after TAP | 11-point NRS (0-10, 0=no pain, 10=worst possible pain) |
| Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96. | 48, 72, 96 hours | Number of pills |
| Incidence of Prespecified Opioid-related Adverse Events | Until hospital discharge order was written, anticipated at 24 hours. | Number of subjects |
| Overall Rating of Subject Satisfaction With Postsurgical Pain Control | 24 hours, 72 hours, and day 10 | Mean of subject satisfaction offered on a 5-point Likert scale (1 = extremely dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = extremely satisfied) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EXPAREL 20 mL Group receiving EXPAREL 20 mL | 12 |
| EXPAREL 40 mL Group receiving EXPAREL 40 mL | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | EXPAREL 40 mL | EXPAREL 20 mL | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 6 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 6 Participants | 15 Participants |
| Age, Continuous | 61.7 years STANDARD_DEVIATION 7.01 | 60.7 years STANDARD_DEVIATION 7.24 | 61.2 years STANDARD_DEVIATION 6.99 |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 1 / 12 |
| serious Total, serious adverse events | 3 / 12 | 0 / 12 |
Outcome results
Primary
The Duration of Abdominal Analgesia From Infiltration Into the TAP
Time frame: First postsurgical administration of an opioid
Population: Per protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| EXPAREL 20 mL | The Duration of Abdominal Analgesia From Infiltration Into the TAP | 0.39 hours |
| EXPAREL 40 mL | The Duration of Abdominal Analgesia From Infiltration Into the TAP | 0.44 hours |
Secondary
Incidence of Prespecified Opioid-related Adverse Events
Number of subjects
Time frame: Until hospital discharge order was written, anticipated at 24 hours.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EXPAREL 20 mL | Incidence of Prespecified Opioid-related Adverse Events | 0 Number of subjects |
| EXPAREL 40 mL | Incidence of Prespecified Opioid-related Adverse Events | 0 Number of subjects |
Secondary
Overall Rating of Subject Satisfaction With Postsurgical Pain Control
Mean of subject satisfaction offered on a 5-point Likert scale (1 = extremely dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = extremely satisfied)
Time frame: 24 hours, 72 hours, and day 10
Population: Number analyzed in one or more rows differs from overall number analyzed in the instances that participant did not complete the assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EXPAREL 20 mL | Overall Rating of Subject Satisfaction With Postsurgical Pain Control | Day 10 - satisfied | 3 Participants |
| EXPAREL 20 mL | Overall Rating of Subject Satisfaction With Postsurgical Pain Control | 72 hours - satisfied | 4 Participants |
| EXPAREL 20 mL | Overall Rating of Subject Satisfaction With Postsurgical Pain Control | 24 hours- extremely satisfied | 8 Participants |
| EXPAREL 20 mL | Overall Rating of Subject Satisfaction With Postsurgical Pain Control | 72 hours - extremely satisfied | 7 Participants |
| EXPAREL 20 mL | Overall Rating of Subject Satisfaction With Postsurgical Pain Control | Day 10- extremely satisfied | 8 Participants |
| EXPAREL 20 mL | Overall Rating of Subject Satisfaction With Postsurgical Pain Control | 24 hours- satisfied | 4 Participants |
| EXPAREL 40 mL | Overall Rating of Subject Satisfaction With Postsurgical Pain Control | Day 10- extremely satisfied | 7 Participants |
| EXPAREL 40 mL | Overall Rating of Subject Satisfaction With Postsurgical Pain Control | Day 10 - satisfied | 4 Participants |
| EXPAREL 40 mL | Overall Rating of Subject Satisfaction With Postsurgical Pain Control | 72 hours - extremely satisfied | 7 Participants |
| EXPAREL 40 mL | Overall Rating of Subject Satisfaction With Postsurgical Pain Control | 24 hours- satisfied | 5 Participants |
| EXPAREL 40 mL | Overall Rating of Subject Satisfaction With Postsurgical Pain Control | 24 hours- extremely satisfied | 7 Participants |
| EXPAREL 40 mL | Overall Rating of Subject Satisfaction With Postsurgical Pain Control | 72 hours - satisfied | 4 Participants |
Secondary
Physician/Healthcare Professional Assessed Postsurgical Pain
11-point NRS (0-10, 0=no pain, 10=worst possible pain)
Time frame: 1, 2, 6, 12, 24 hours after TAP
Population: Number analyzed in one or more rows differs from overall number analyzed in the instances that participant did not complete the assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EXPAREL 20 mL | Physician/Healthcare Professional Assessed Postsurgical Pain | 2 hours after TAP | 2.9 units on a scale | Standard Deviation 1.56 |
| EXPAREL 20 mL | Physician/Healthcare Professional Assessed Postsurgical Pain | 12 hours after TAP | 2.6 units on a scale | Standard Deviation 2.07 |
| EXPAREL 20 mL | Physician/Healthcare Professional Assessed Postsurgical Pain | 6 hours after TAP | 2.4 units on a scale | Standard Deviation 1.57 |
| EXPAREL 20 mL | Physician/Healthcare Professional Assessed Postsurgical Pain | 24 hours after TAP | 1.8 units on a scale | Standard Deviation 1.75 |
| EXPAREL 20 mL | Physician/Healthcare Professional Assessed Postsurgical Pain | 1 hour after TAP | 4.2 units on a scale | Standard Deviation 2.33 |
| EXPAREL 40 mL | Physician/Healthcare Professional Assessed Postsurgical Pain | 24 hours after TAP | 2.5 units on a scale | Standard Deviation 1.68 |
| EXPAREL 40 mL | Physician/Healthcare Professional Assessed Postsurgical Pain | 1 hour after TAP | 5.3 units on a scale | Standard Deviation 2.35 |
| EXPAREL 40 mL | Physician/Healthcare Professional Assessed Postsurgical Pain | 2 hours after TAP | 3.9 units on a scale | Standard Deviation 2.15 |
| EXPAREL 40 mL | Physician/Healthcare Professional Assessed Postsurgical Pain | 6 hours after TAP | 3.0 units on a scale | Standard Deviation 2.1 |
| EXPAREL 40 mL | Physician/Healthcare Professional Assessed Postsurgical Pain | 12 hours after TAP | 2.2 units on a scale | Standard Deviation 1.33 |
Secondary
Subject Reported Postsurgical Pain
11-point numeric rating scale (NRS) (0-10, where 0=no pain, 10=worst possible pain)
Time frame: 1, 2, 6, 12, 24, 48, 72, 96 hours and 10 days after TAP
Population: Number analyzed in one or more rows differs from overall number analyzed in the instances that participant did not complete the assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EXPAREL 20 mL | Subject Reported Postsurgical Pain | 6 hours after TAP | 2.4 units on a scale | Standard Deviation 1.57 |
| EXPAREL 20 mL | Subject Reported Postsurgical Pain | 2 hours after TAP | 3.1 units on a scale | Standard Deviation 1.5 |
| EXPAREL 20 mL | Subject Reported Postsurgical Pain | 24 hours after TAP | 1.8 units on a scale | Standard Deviation 1.75 |
| EXPAREL 20 mL | Subject Reported Postsurgical Pain | 72 hours after TAP | 1.8 units on a scale | Standard Deviation 1.64 |
| EXPAREL 20 mL | Subject Reported Postsurgical Pain | 48 hours after TAP | 2.0 units on a scale | Standard Deviation 1.54 |
| EXPAREL 20 mL | Subject Reported Postsurgical Pain | 12 hours after TAP | 2.5 units on a scale | Standard Deviation 2.12 |
| EXPAREL 20 mL | Subject Reported Postsurgical Pain | 96 hours after TAP | 1.1 units on a scale | Standard Deviation 1.08 |
| EXPAREL 20 mL | Subject Reported Postsurgical Pain | Day 10 after TAP | 0.00 units on a scale | Standard Deviation 0 |
| EXPAREL 20 mL | Subject Reported Postsurgical Pain | 1 hour after TAP | 4.4 units on a scale | Standard Deviation 2.57 |
| EXPAREL 40 mL | Subject Reported Postsurgical Pain | Day 10 after TAP | 1.0 units on a scale | Standard Deviation 1.55 |
| EXPAREL 40 mL | Subject Reported Postsurgical Pain | 2 hours after TAP | 3.9 units on a scale | Standard Deviation 2.15 |
| EXPAREL 40 mL | Subject Reported Postsurgical Pain | 6 hours after TAP | 3.0 units on a scale | Standard Deviation 2.1 |
| EXPAREL 40 mL | Subject Reported Postsurgical Pain | 12 hours after TAP | 2.2 units on a scale | Standard Deviation 1.6 |
| EXPAREL 40 mL | Subject Reported Postsurgical Pain | 72 hours after TAP | 1.9 units on a scale | Standard Deviation 1.83 |
| EXPAREL 40 mL | Subject Reported Postsurgical Pain | 1 hour after TAP | 5.3 units on a scale | Standard Deviation 2.35 |
| EXPAREL 40 mL | Subject Reported Postsurgical Pain | 24 hours after TAP | 2.5 units on a scale | Standard Deviation 1.68 |
| EXPAREL 40 mL | Subject Reported Postsurgical Pain | 48 hours after TAP | 2.5 units on a scale | Standard Deviation 2.61 |
| EXPAREL 40 mL | Subject Reported Postsurgical Pain | 96 hours after TAP | 1.7 units on a scale | Standard Deviation 2.06 |
Secondary
Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96.
Number of pills
Time frame: 48, 72, 96 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EXPAREL 20 mL | Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96. | 48 hours | 1.9 Number of tablets | Standard Deviation 2.11 |
| EXPAREL 20 mL | Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96. | 72 hours | 2.8 Number of tablets | Standard Deviation 3.21 |
| EXPAREL 20 mL | Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96. | 96 hours | 3.7 Number of tablets | Standard Deviation 4.25 |
| EXPAREL 40 mL | Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96. | 96 hours | 4.8 Number of tablets | Standard Deviation 5.33 |
| EXPAREL 40 mL | Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96. | 48 hours | 2.2 Number of tablets | Standard Deviation 2.12 |
| EXPAREL 40 mL | Total Postsurgical Oxycodone/Acetaminophen Consumption From Hospital Discharge Through Hour 96. | 72 hours | 3.4 Number of tablets | Standard Deviation 3.75 |