Pain
Conditions
Keywords
anesthesia, surgery, pain
Brief summary
The purpose of this study is to compare the efficacy and duration of bupivacaine extended-release liposome injection (Exparel) versus bupivacaine with dexamethasone in transversus abdominis plane (TAP) blocks for patients undergoing abdominal surgery at Emory University Hospital and Emory University Hospital Midtown. The investigators hypothesize that Exparel will provide greater postoperative pain relief than bupivacaine with dexamethasone. The investigators plan to enroll up to 50 male and female subjects meeting inclusion and exclusion criteria who will be randomized to receive either Exparel (Group 1) or bupivacaine with epinephrine and dexamethasone (Group 2) in the TAP block to achieve at least 22 subjects in each group
Detailed description
Group 1 will be administered 266 mg of Exparel, diluted to 30 mL. Group 2 will be given 28 mL of 0.375% bupivacaine and 8mg/2 mL dexamethasone.Before injection of the study medication, 2mL of normal saline with be injected under ultrasound visualization to ensure needle tip is in the transversus abdominis plane.Randomization will occur following the written informed consent and prior to the start of the surgical procedure. Postoperatively, study patients will receive intravenous acetaminophen 1000mg every 8 hours for 3 doses, then oral acetaminophen 650mg every 6 hours. Subjects will also have patient-controlled analgesia (PCA) with morphine or hydromorphone. The research staff recording data will be blinded to the treatment group. Demographic data will be recorded, including age, date of birth, height and weight to ensure similarity between the two groups. A medical history will be obtained as well as surgical and anesthesia details. Study patients will be followed for 72 hours postoperatively to record the amount of opioid consumption, as well as other pain score data using the Visual Analogue Scale (VAS).The subject's participation will end 72 hours after surgery. A telephone interview will occur with the subject if hospital discharge occurs prior to 72 hours.
Interventions
DRUGBupivacaine Extended-Release Liposome Injection (Exparel)
266mg/30mL of Exparel will be injected via unilateral TAP block
DRUGBupivacaine and Dexamethasone Injection
As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone will be injected via unilateral TAP block.
DRUGIV Acetaminophen
Intravenous (IV) acetaminophen 1000 mg every 8 hours for 8 doses.
Oral acetaminophen 650 mg every 6 hours.
Sponsors
Colette Curtis MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients undergoing scheduled abdominal surgery at Emory University Hospital or Emory University Hospital Midtown * Patients willing and able to provide written informed consent
Exclusion criteria
* Patients less than 18 years of age, since Exparel has not been studied in this age group * Patients who are pregnant or lactating, since Exparel has not been shown to be safe in this population, and because of potential drug transfer to child * Patients with uncontrolled diabetes since dexamethasone may cause hyperglycemia * Patients with liver dysfunction, since bupivacaine is hepatically metabolized * Patients with renal failure, since bupivacaine is renally excreted, defined as requiring hemodialysis or renal replacement therapy * Patients with allergy to one of the study drugs * Patients with local infection, which may be exacerbated by dexamethasone * Patients with significant opioid tolerance, defined as taking at least 60 mg oral morphine per day, 3 mg oral oxycodone per day, 25 mcg/hr fentanyl patch, 25 mg oral oxymorphone per day, 8 mg of oral hydromorphone per day or an equianalgesic dose of another opioid for one week or longer * Patients with known coagulopathy, since bleeding risk is higher Patients who are getting neuraxial anesthesia for surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Opioid Consumption | Post Surgery (Up to 72 Hours) | The investigators will collect the total amount of opioid consumption for the 72 hour post operative period in each group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Visual Analogue Scale (VAS) Pain Score at Rest | Post-Surgery 24 Hours, 48 Hours, 72 Hours | The VAS method of pain assessment (scale of 1- 10) will be used to measure the participant's pain level at rest each day during the 72 hours post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain. |
| Mean Visual Analogue Scale (VAS) Pain Score With Movement | Post-Surgery 24 Hours, 48 Hours, 72 Hours | The VAS method of pain assessment (scale of 1-10) will be used to measure the patient's level of pain with movement each day during the 72 hour post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain. |
| Mean Time of First Opioid Use | Post-surgery (Up to 72 Hours) | The time of first opioid use after surgery will be recorded for up to 72 hours. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the Emory University Hospital and the Emory University Hospital Midtown between July 2014 through June 2015.
Participants by arm
| Arm | Count |
|---|---|
| Group 1-Exparel Bupivacaine Extended-Release Liposome Injection (Exparel) was administered via TAP block procedure
Bupivacaine Extended-Release Liposome Injection (Exparel): 266mg/30mL of Exparel was injected via unilateral TAP block | 5 |
| Group 2-Bupivacaine and Dexamethasone IV Bupivacaine and Dexamethasone Injection was administered via TAP block procedure.
Bupivacaine and Dexamethasone Injection: As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone was injected via unilateral TAP block. | 4 |
| Total | 9 |
Baseline characteristics
| Characteristic | Group 2-Bupivacaine and Dexamethasone IV | Total | Group 1-Exparel |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 7 Participants | 4 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 4 participants | 9 participants | 5 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 3 Participants | 7 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 |
Outcome results
Primary
Mean Opioid Consumption
The investigators will collect the total amount of opioid consumption for the 72 hour post operative period in each group.
Time frame: Post Surgery (Up to 72 Hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1-Exparel | Mean Opioid Consumption | 507 milligrams | Standard Deviation 602 |
| Group 2-Bupivacaine and Dexamethasone IV | Mean Opioid Consumption | 392 milligrams | Standard Deviation 133 |
Secondary
Mean Time of First Opioid Use
The time of first opioid use after surgery will be recorded for up to 72 hours.
Time frame: Post-surgery (Up to 72 Hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1-Exparel | Mean Time of First Opioid Use | 58 hours | Standard Deviation 29 |
| Group 2-Bupivacaine and Dexamethasone IV | Mean Time of First Opioid Use | 46 hours | Standard Deviation 31 |
Secondary
Mean Visual Analogue Scale (VAS) Pain Score at Rest
The VAS method of pain assessment (scale of 1- 10) will be used to measure the participant's pain level at rest each day during the 72 hours post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain.
Time frame: Post-Surgery 24 Hours, 48 Hours, 72 Hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1-Exparel | Mean Visual Analogue Scale (VAS) Pain Score at Rest | 24 Hours Post Surgery | 4.2 units on a scale | Standard Deviation 1.9 |
| Group 1-Exparel | Mean Visual Analogue Scale (VAS) Pain Score at Rest | 48 Hours Post Surgery | 1.8 units on a scale | Standard Deviation 1.6 |
| Group 1-Exparel | Mean Visual Analogue Scale (VAS) Pain Score at Rest | 72 Hours Post Surgery | 1.8 units on a scale | Standard Deviation 2 |
| Group 2-Bupivacaine and Dexamethasone IV | Mean Visual Analogue Scale (VAS) Pain Score at Rest | 24 Hours Post Surgery | 3.5 units on a scale | Standard Deviation 1.3 |
| Group 2-Bupivacaine and Dexamethasone IV | Mean Visual Analogue Scale (VAS) Pain Score at Rest | 48 Hours Post Surgery | 3.3 units on a scale | Standard Deviation 2.6 |
| Group 2-Bupivacaine and Dexamethasone IV | Mean Visual Analogue Scale (VAS) Pain Score at Rest | 72 Hours Post Surgery | 3.5 units on a scale | Standard Deviation 2.6 |
Secondary
Mean Visual Analogue Scale (VAS) Pain Score With Movement
The VAS method of pain assessment (scale of 1-10) will be used to measure the patient's level of pain with movement each day during the 72 hour post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain.
Time frame: Post-Surgery 24 Hours, 48 Hours, 72 Hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1-Exparel | Mean Visual Analogue Scale (VAS) Pain Score With Movement | 24 Hours Post Surgery | 6.8 units on a scale | Standard Deviation 3.4 |
| Group 1-Exparel | Mean Visual Analogue Scale (VAS) Pain Score With Movement | 48 Hours Post Surgery | 6.6 units on a scale | Standard Deviation 4.1 |
| Group 1-Exparel | Mean Visual Analogue Scale (VAS) Pain Score With Movement | 72 Hours Post Surgery | 3.6 units on a scale | Standard Deviation 2.9 |
| Group 2-Bupivacaine and Dexamethasone IV | Mean Visual Analogue Scale (VAS) Pain Score With Movement | 24 Hours Post Surgery | 5.8 units on a scale | Standard Deviation 1.7 |
| Group 2-Bupivacaine and Dexamethasone IV | Mean Visual Analogue Scale (VAS) Pain Score With Movement | 48 Hours Post Surgery | 6.3 units on a scale | Standard Deviation 3.3 |
| Group 2-Bupivacaine and Dexamethasone IV | Mean Visual Analogue Scale (VAS) Pain Score With Movement | 72 Hours Post Surgery | 4.8 units on a scale | Standard Deviation 2.9 |