Pain
Conditions
Keywords
Pain Management, Exparel, Abdominal Hernia Repair, Laparoscopic Surgery
Brief summary
The purpose of this study is to learn how well Liposomal Bupivacaine (Exparel™) controls post-operative pain in patients undergoing both open and laparoscopic (minimally invasive) abdominal hernia repair surgery.
Detailed description
When a person has surgery, there are a few different standard care options for pain relief. Anesthetic (numbing) drugs can be used to cause a loss of feeling in or around a wound but the effect of the numbing medication can be undone.Pain relieving drugs such as acetaminophen (Tylenol), non-steroidal anti-inflammatory drugs (NSAIDs), and opioid (narcotic) medications can also be taken by mouth or through a vein in your arm (intravenous IV.) However, both NSAIDs & Opioid drugs can produce negative side effects such as serious difficulty breathing, stopping breathing altogether, low blood pressure, nausea, vomiting, itching, and constipation. Bupivacaine is one of the commonly used longer-acting numbing medicines (anesthetics). The effect of Bupivacaine or other anesthetics is limited to usually no more than 12 hours when injected around the area of the incision during surgery. Liposomal Bupivacaine (Exparel) could provide good, continuous and longer pain relief than current therapies/treatments commonly used. This can possibly improve patient satisfaction and time to normal activities such as walking.
Interventions
DRUGEXPAREL
DRUGKetorolac
PROCEDURElaparoscopic abdominal hernia repair
PROCEDUREan open surgery for abdominal hernia repair
Sponsors
Pacira Pharmaceuticals, Inc
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled to undergo an open or laparoscopic abdominal hernia repair. * Ability to provide informed consent, adhere to study visit schedule, and complete all study assessments.
Exclusion criteria
* Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioids or ketorolac. * Patients who abuse alcohol or other drug substance. * Patients who are on chronic opioid therapy (taken an opioid 5 of the last 7 days). * Patients with severe hepatic impairment. * Patients currently pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With Pain Management After Surgery | Change from Surgery to Day 14 | Satisfaction measured with composite score that includes score from the Likert scale and opioid consumption/satisfaction log. Satisfaction was rated on a scale of 1-5, with 1 being strongly disagree/not satisfied with pain control and 5 being strongly agree/satisfied with pain control. Patients filled out the log on days 1-4 after surgery and at a 7-14 day follow up visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Length of Time in Post-anesthesia Care Unit (PACU) | Up to 385 minutes after surgery | Length of time subjects stayed in the PACU following surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Laparoscopic Treatment Arm All patients 18 and older presenting with an abdominal hernia requiring laparoscopic repair were screened for inclusion. | 7 |
| Laparoscopic Control Arm All patients 18 and older presenting with an abdominal hernia requiring laparoscopic repair were screened for inclusion. | 4 |
| Open Treatment Arm All patients 18 and older presenting with an abdominal hernia requiring open surgical repair were screened for inclusion. | 5 |
| Open Control Arm All patients 18 and older presenting with an abdominal hernia requiring open surgical repair were screened for inclusion. | 3 |
| Total | 19 |
Baseline characteristics
| Characteristic | Laparoscopic Control Arm | Open Treatment Arm | Laparoscopic Treatment Arm | Open Control Arm | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 3 Participants | 3 Participants | 1 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 2 Participants | 4 Participants | 2 Participants | 11 Participants |
| Age, Continuous | 62 years | 74.5 years | 60.5 years | 55.5 years | 64 years |
| Region of Enrollment United States | 4 Participants | 5 Participants | 7 Participants | 3 Participants | 19 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 5 Participants | 2 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 5 | 0 / 4 | 0 / 7 |
| other Total, other adverse events | 0 / 2 | 0 / 5 | 0 / 4 | 0 / 7 |
| serious Total, serious adverse events | 0 / 2 | 0 / 5 | 0 / 4 | 0 / 7 |
Outcome results
Primary
Patient Satisfaction With Pain Management After Surgery
Satisfaction measured with composite score that includes score from the Likert scale and opioid consumption/satisfaction log. Satisfaction was rated on a scale of 1-5, with 1 being strongly disagree/not satisfied with pain control and 5 being strongly agree/satisfied with pain control. Patients filled out the log on days 1-4 after surgery and at a 7-14 day follow up visit.
Time frame: Change from Surgery to Day 14
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Laparoscopic Control Arm | Patient Satisfaction With Pain Management After Surgery | 4 score on a scale |
| Laparoscopic Treatment Arm | Patient Satisfaction With Pain Management After Surgery | 4 score on a scale |
| Open Control Arm | Patient Satisfaction With Pain Management After Surgery | 2.5 score on a scale |
| Open Treatment Arm | Patient Satisfaction With Pain Management After Surgery | 5 score on a scale |
Secondary
Total Length of Time in Post-anesthesia Care Unit (PACU)
Length of time subjects stayed in the PACU following surgery
Time frame: Up to 385 minutes after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Laparoscopic Control Arm | Total Length of Time in Post-anesthesia Care Unit (PACU) | 93.5 minutes |
| Laparoscopic Treatment Arm | Total Length of Time in Post-anesthesia Care Unit (PACU) | 64 minutes |
| Open Control Arm | Total Length of Time in Post-anesthesia Care Unit (PACU) | 118 minutes |
| Open Treatment Arm | Total Length of Time in Post-anesthesia Care Unit (PACU) | 86 minutes |