Pain
Conditions
Keywords
Exparel, Thoracoscopy, Bupivicaine, Liposomal
Brief summary
This study is looking to evaluate the efficacy of liposomal bupivicaine (Exparel) on decreasing the amount of consumed pain medications. Patients will be randomly selected to received either Exparel or standard bupivicaine injection during surgery. Patients will be followed up to assess pain levels using a visual pain scale, and to assess how much pain medication was consumed.
Detailed description
Exparel is a formulation of liposomal bupivacaine that is reported to allow local anesthesia for up to 72 hours post injection. It is the investigators' aim to follow their prior study with a randomized trial to compare local infiltration of liposomal bupivacaine at the conclusion of each procedure with injections of standard .25% bupivacaine. Patients in group A will receive, at the end of the surgical procedure, injections of liposomal bupivacaine (Exparel) (266 mg, 20 mL, diluted at surgeon's discretion) into the thoracoscopic port incision sites and around the intercostal nerves serving that space. Patients in group B will receive, at the end of the surgical procedure, injections of standard .25% bupivacaine into the thoracoscopic port incision sites and around the intercostal nerves serving that space.
Interventions
266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.
DRUG0.25% standard bupivicaine
standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.
Sponsors
Mednax National Medical Group
Inova Health Care Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients over 18 years of age * Isolated thoracoscopic procedure for therapeutic or diagnostic purposes
Exclusion criteria
* Previous ipsilateral thoracic surgery * Need for operative pleurectomy or pleurodesis * Chronic use of pain medication -narcotics or nonsteroidal antiinflammatory drugs (NSAIDs), sedatives, or hypnotics * Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or acetaminophen * Liver dysfunction (INR \> 1.5, albumin \< 2.8g/dl, bilirubin \> 2mg/dl) * Renal dysfunction (eGFR \< 60ml/min/1.73m2) * History of peptic ulcerative disease * Severe chronic obstructive pulmonary disease (COPD) requiring continuous oxygen supplementation * Inability to consent * Pregnancy * Need for conversion from a Video-Assisted Thoracic Surgery procedure to a thoracotomy * Patient is discharged from the hospital with a chest tube in place * Patient fails to comply with post-operative instructions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Amounts of Pain Medications Consumed Through Post-operative Day 7 | Assessed daily for 7 days post-procedure | Using questionnaires, patients are asked if they took Dilaudid, Tylenol, Motrin, or other opioids and if so, how many tablets. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scores on an Analog Pain Scale (30 Days) | Assessed at 30 days post-procedure | Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain. |
| Number of Patients With Paresthesias (Postoperatively at 7 Days) | Assessed at day 7 post-procedure | Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves since the procedure. |
| Proportion of Patients With Paresthesias (Postoperatively at 30 Days) | Assessed at day 30 post-procedure | Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves |
| Hospital Length of Stay | From end of procedure until discharge, usually 0-2 days. | Median length of stay in days until discharge. |
| Scores on a Analog Pain Scale (7 Days) | Assessed at day 7 post-procedure | Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain. |
| Return to Work | Assessed at 30 days post-procedure | Using surveys, patients are asked if they have been able to return to work. |
| Days Until Return to Work | Assessed at 30 days post-procedure | Using surveys, the number of days to return to work was assessed for patients who were able to return to work. |
| Overall Hospital Cost | Total cost assessed from patient registration until discharge to home (usually 0-2 days). | Overall hospital cost of patient procedure and stay will be assessed. |
| Return to Baseline Activity | Assessed at 30 days post-procedure | Using surveys, patients are asked if they have been able to return to baseline activity levels. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exparel Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.
Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle. | 49 |
| 0.25% Standard Bupivicaine Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.
0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle. | 49 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 30-Day Follow-Up Phone Call | Lost to Follow-up | 3 | 1 |
| 30-Day Follow-Up Phone Call | Other | 1 | 0 |
| 30-Day Follow-Up Phone Call | Withdrawal by Subject | 1 | 1 |
| 30-Day Follow-Up Phone Call | Withdrawal due to ineligibility | 2 | 0 |
| Randomization | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Exparel | Total | 0.25% Standard Bupivicaine |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 10.9 | 64 years STANDARD_DEVIATION 11 | 65 years STANDARD_DEVIATION 10.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 10 Participants | 3 Participants |
| Race (NIH/OMB) White | 36 Participants | 77 Participants | 41 Participants |
| Region of Enrollment United States | 49 participants | 98 participants | 49 participants |
| Sex: Female, Male Female | 28 Participants | 55 Participants | 27 Participants |
| Sex: Female, Male Male | 21 Participants | 43 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 49 |
| other Total, other adverse events | 5 / 49 | 0 / 49 |
| serious Total, serious adverse events | 1 / 49 | 0 / 49 |
Outcome results
Primary
Overall Amounts of Pain Medications Consumed Through Post-operative Day 7
Using questionnaires, patients are asked if they took Dilaudid, Tylenol, Motrin, or other opioids and if so, how many tablets.
Time frame: Assessed daily for 7 days post-procedure
Population: 4 participants from the Exparel group and 6 participants from the standard group did not return a questionnaire.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exparel | Overall Amounts of Pain Medications Consumed Through Post-operative Day 7 | 1294 tablets |
| 0.25% Standard Bupivicaine | Overall Amounts of Pain Medications Consumed Through Post-operative Day 7 | 1455.5 tablets |
Secondary
Days Until Return to Work
Using surveys, the number of days to return to work was assessed for patients who were able to return to work.
Time frame: Assessed at 30 days post-procedure
Population: At the 30-day call, 24 subjects in the Exparel group and 17 subjects in the standard group indicated that they were able to return to work. Number of days were assessed for these subjects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Exparel | Days Until Return to Work | 6.5 days |
| 0.25% Standard Bupivicaine | Days Until Return to Work | 5 days |
Secondary
Hospital Length of Stay
Median length of stay in days until discharge.
Time frame: From end of procedure until discharge, usually 0-2 days.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Exparel | Hospital Length of Stay | 0 days |
| 0.25% Standard Bupivicaine | Hospital Length of Stay | 0 days |
Secondary
Number of Patients With Paresthesias (Postoperatively at 7 Days)
Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves since the procedure.
Time frame: Assessed at day 7 post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exparel | Number of Patients With Paresthesias (Postoperatively at 7 Days) | 10 Participants |
| 0.25% Standard Bupivicaine | Number of Patients With Paresthesias (Postoperatively at 7 Days) | 20 Participants |
Secondary
Overall Hospital Cost
Overall hospital cost of patient procedure and stay will be assessed.
Time frame: Total cost assessed from patient registration until discharge to home (usually 0-2 days).
Population: Data on hospital cost was not collected.
Secondary
Proportion of Patients With Paresthesias (Postoperatively at 30 Days)
Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves
Time frame: Assessed at day 30 post-procedure
Population: 42 subjects in the Exparel group and 47 subjects in the standard group completed the 30-day survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exparel | Proportion of Patients With Paresthesias (Postoperatively at 30 Days) | 6 Participants |
| 0.25% Standard Bupivicaine | Proportion of Patients With Paresthesias (Postoperatively at 30 Days) | 5 Participants |
Secondary
Return to Baseline Activity
Using surveys, patients are asked if they have been able to return to baseline activity levels.
Time frame: Assessed at 30 days post-procedure
Population: 42 subjects in the Exparel group and 47 subjects in the standard group completed the 30 day survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exparel | Return to Baseline Activity | 40 Participants |
| 0.25% Standard Bupivicaine | Return to Baseline Activity | 47 Participants |
Secondary
Return to Work
Using surveys, patients are asked if they have been able to return to work.
Time frame: Assessed at 30 days post-procedure
Population: 42 subjects in the Exparel group and 47 patients in the standard group completed the 30-day survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exparel | Return to Work | 24 Participants |
| 0.25% Standard Bupivicaine | Return to Work | 17 Participants |
Secondary
Scores on a Analog Pain Scale (7 Days)
Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain.
Time frame: Assessed at day 7 post-procedure
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Exparel | Scores on a Analog Pain Scale (7 Days) | 1.5 Median score on postoperative day 7 |
| 0.25% Standard Bupivicaine | Scores on a Analog Pain Scale (7 Days) | 1 Median score on postoperative day 7 |
Secondary
Scores on an Analog Pain Scale (30 Days)
Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain.
Time frame: Assessed at 30 days post-procedure
Population: 42 subjects in the Exparel group and 47 subjects in the standard group completed the 30-day survey.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Exparel | Scores on an Analog Pain Scale (30 Days) | 0 Median score on postoperative day 30 |
| 0.25% Standard Bupivicaine | Scores on an Analog Pain Scale (30 Days) | 0 Median score on postoperative day 30 |