Coronary Artery Disease, Coronary Artery Stenoses, Valve Regurgitation, Mitral, Valve Regurgitation, Tricuspid
Conditions
Keywords
cardiac surgery, sternotomy, post-operative pain, sternal wound infiltration
Brief summary
The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and cardiopulmonary bypass (CPB) and compare it with bupivacaine hydrochloride infiltration
Detailed description
There are no studies to date on the use of LB infiltration and its analgesic efficacy in cardiac surgery done through sternotomy, even though the majority of cardiac surgeries utilize this approach. Moderate to severe pain is common in patients undergoing these surgeries and is usually inadequately treated. Other various pain treatment modalities such as opioid and neuraxial anesthesia are avoided due to potentially dangerous side effects in this cohort. The efficacy of local anesthesia techniques, such as bupivacaine, are limited due to short duration of action and increased incidence of wound infection. On the other hand, slow release liposomal bupivacaine may last up to 72 hours, indicating it's potential for more adequate analgesia compared to bupivacaine.
Interventions
Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
DRUGBupivacaine Hydrochloride
Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
Sponsors
Pacira Pharmaceuticals, Inc
Kathirvel Subramaniam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, care provider, investigator, and outcomes assessor are all blinded to the treatment allocation in double-blind fashion
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Open cardiac surgery through sternotomy approach (eg. coronary artery bypass graft, valvular heart procedures, as well as other open cardiac procedures along with coronary artery bypass) * Surgery with the use of cardiopulmonary bypass
Exclusion criteria
* Minimally invasive heart surgery through thoracotomy approach * Patient undergoing procedures under deep hypothermic circulatory arrest * Patients with active infections such as infective endocarditis * Emergency surgery * Patients undergoing transplantations and ventricular assist device insertion * Patients on any mechanical circulatory support preoperatively * Patient's refusal * End stage liver or renal disease * Allergy to bupivacaine * Patient who cannot understand the study procedure or refuse to participate * Redo-sternotomy * Participation in another study * Patients with severe right or left ventricular dysfunction (EF\< 25%) * Patients requiring chronic opioids for chronic pain condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Narcotic Consumption | 0-72 hours post-operative period | All narcotics administered in the first 0-8, 8-24, 24-48, and 48-72 hours and the total narcotics administered in the 0-72 hours postoperative period(PCA narcotics, nurse-administered IV narcotics, and oral narcotics). All narcotics will be converted to total IV morphine equivalent for comparison between two groups. |
| Post-operative Pain Intensity | NRS scores will be evaluated every 4 hours until 24 hours post-operatively, every 8 hours until 48 hours post-operatively, and every 12 hours for 72 hours post-operatively | Postoperative pain scores evaluated by numeric rating scale or (NRS) where 0- no pain and 10- worst pain, at rest and at movement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Re-intubation | From time of end of surgery to patient discharge up to one week | Instances of re-intubation will be recorded |
| Major Organ Dysfunction | From date of surgery assessed up to 30 day post-operatively | Organ systems such as cardiac, renal, respiratory, and nervous system failure/dysfunction in accordance with the Society of Thoracic Surgeon's database will be noted |
| Length of Hospital and ICU Stay | From date of surgery assessed up to 30 day post-operatively | Length of both hospital and ICU stay will be measured |
| Hospital Readmission | From end of surgery assessed up to 30 days post-operatively | Readmission to hospital will be noted |
| Mortality | From end of surgery assessed up to 30 days post-operatively | Mortality will be noted at specific timepoints |
| Time to Extubation | From the end of surgery until the patient is extubated up to 72 hours post-operatively | The time it takes until the patient is extubated post-operatively will be measured |
| Patient Time to Mobilization | From time of end of surgery to time of mobilization up to 72 hours or discharge, *assessed up to 120 hours* | The time it takes until patient ambulates will be measured |
| Patient Time to Out of Bed to Chair | From time of end of surgery to time of mobilization up to 72 hours post-operatively | The time it takes until the patient advances from bedrest to out of bed (OOB) to chair will be measured |
| Patient Time to Oral Intake | From time of end of surgery to time of oral intake up to 72 hours post-operatively or until hospital discharge | The time it takes until the patient is able to/medically cleared to consume food or liquid will be measured |
| Non-invasive Ventilation (NIV) Requirement | From time of end of surgery to 72 hours post-operatively or until hospital discharge | Episodes of NIV such as upper airway masks or similar devices will be quantified |
| Use of Incentive Spirometry | From time of end of surgery to 72 hours post-operatively | Frequency of incentive spirometry will be measured |
| Post-operative Nausea and Vomiting | From time of end of surgery to 72 hours post-operatively | Whether a patient experiences at least one episode of nausea and emesis will be measured |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serum Cortisol Levels | Measured 8, 48, and 72 hours post-operatively | Stress response suppression as a result of treatment will be evaluated by comparing hormone levels between the groups. Serum cortisol levels will be taken to measure this. |
| Chronic Pain Assessment | 6 months after surgery | Subjects will be asked the two following questions: Are you currently experiencing pain? as well as Are you experiencing moderate to severe pain? with moderate to severe indicated as a pain score of 4-10 on 0 to 10 scale, with 0 being no pain at all and 10 being the worst pain imaginable. |
| Delirium | Assessment will be administered at 48 hours post-operatively | Patients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC) |
| Patient Satisfaction | Given at the time of discharge up to 30 days post-operatively | Patient will give an assessment regarding pain management on a scale of 0 - 10 with 0 indicating the lowest satisfaction with pain management and 10 indicating the highest satisfaction with pain management |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exparel Injectable Product Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\
30).
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision) | 29 |
| Bupivacaine Hydrochloride Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\
30).
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision) | 31 |
| Total | 60 |
Baseline characteristics
| Characteristic | Bupivacaine Hydrochloride | Total | Exparel Injectable Product |
|---|---|---|---|
| Age, Continuous | 65 years | 65.5 years | 67 years |
| Angiotensin converting enzyme inhibitor/angiotensin receptor blocker use | 4 Participants | 10 Participants | 6 Participants |
| Aspirin within 5 days preoperatively | 30 Participants | 55 Participants | 25 Participants |
| Betablockers within 2 weeks preoperatively | 18 Participants | 40 Participants | 22 Participants |
| Body Mass Index | 31.3 kg/m^2 | 31.7 kg/m^2 | 32 kg/m^2 |
| Cerebrovascular disease | 2 Participants | 3 Participants | 1 Participants |
| Chronic lung disease Mild or no disease | 31 Participants | 57 Participants | 26 Participants |
| Chronic lung disease Severe | 0 Participants | 2 Participants | 2 Participants |
| Chronic lung disease Unknown | 0 Participants | 1 Participants | 1 Participants |
| Congestive heart failure | 5 Participants | 10 Participants | 5 Participants |
| Diabetes mellitus | 14 Participants | 29 Participants | 15 Participants |
| Duration of cardiopulmonary bypass | 134 minutes | 129 minutes | 128 minutes |
| Duration of surgery | 335 minutes | 329 minutes | 305 minutes |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 57 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Hematocrit | 41.8 Percentage Hematocrit | 41.5 Percentage Hematocrit | 40.7 Percentage Hematocrit |
| Hypertension | 28 Participants | 55 Participants | 27 Participants |
| Last hemoglobin A1C | 6.0 percentage A1C | 6.1 percentage A1C | 6.2 percentage A1C |
| Left ventricular ejection fraction | 58 percent ejection fraction | 58 percent ejection fraction | 57.5 percent ejection fraction |
| Lipid lowering drugs within 24 hours preoperatively | 25 Participants | 44 Participants | 19 Participants |
| Lowest body temperature on bypass | 33.8 degrees Celcius | 34 degrees Celcius | 34.2 degrees Celcius |
| Peripheral vascular disease | 2 Participants | 4 Participants | 2 Participants |
| Preoperative hospitalization | 15 Participants | 32 Participants | 17 Participants |
| Procedure Combined coronary artery bypass graft & valve procedure | 3 Participants | 6 Participants | 3 Participants |
| Procedure Coronary artery bypass graft | 25 Participants | 50 Participants | 25 Participants |
| Procedure Valve procedure | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 54 Participants | 26 Participants |
| Serum creatinine | 1.0 mg/dL | 1.0 mg/dL | 1.0 mg/dL |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Male | 26 Participants | 50 Participants | 24 Participants |
| Society of thoracic surgeons predicted mortality risk | 0.007 percentage of mortality risk | 0.008 percentage of mortality risk | 0.009 percentage of mortality risk |
| Tobacco use | 15 Participants | 27 Participants | 12 Participants |
| Total albumin | 4.1 g/dL | 4 g/dL | 4 g/dL |
| Total bilirubin | 0.6 mg/dL | 0.6 mg/dL | 0.6 mg/dL |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 29 | 1 / 31 |
| other Total, other adverse events | 3 / 29 | 5 / 31 |
| serious Total, serious adverse events | 5 / 29 | 5 / 31 |
Outcome results
Primary
Post-operative Pain Intensity
Postoperative pain scores evaluated by numeric rating scale or (NRS) where 0- no pain and 10- worst pain, at rest and at movement
Time frame: NRS scores will be evaluated every 4 hours until 24 hours post-operatively, every 8 hours until 48 hours post-operatively, and every 12 hours for 72 hours post-operatively
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Exparel Injectable Product | Post-operative Pain Intensity | 72hrs. with movement | 5.58 score on a scale |
| Exparel Injectable Product | Post-operative Pain Intensity | 4hrs. at rest | 4.7482 score on a scale |
| Exparel Injectable Product | Post-operative Pain Intensity | 4hrs. with movement | 5.75 score on a scale |
| Exparel Injectable Product | Post-operative Pain Intensity | 8hrs. at rest | 4.7262 score on a scale |
| Exparel Injectable Product | Post-operative Pain Intensity | 8hrs. with movement | 5.74 score on a scale |
| Exparel Injectable Product | Post-operative Pain Intensity | 12hrs. at rest | 4.7042 score on a scale |
| Exparel Injectable Product | Post-operative Pain Intensity | 12hrs. with movement | 5.73 score on a scale |
| Exparel Injectable Product | Post-operative Pain Intensity | 16hrs. at rest | 4.6822 score on a scale |
| Exparel Injectable Product | Post-operative Pain Intensity | 16hrs. with movement | 5.72 score on a scale |
| Exparel Injectable Product | Post-operative Pain Intensity | 20hrs. at rest | 4.6602 score on a scale |
| Exparel Injectable Product | Post-operative Pain Intensity | 20hrs. with movement | 5.71 score on a scale |
| Exparel Injectable Product | Post-operative Pain Intensity | 24hrs. at rest | 4.6382 score on a scale |
| Exparel Injectable Product | Post-operative Pain Intensity | 24hrs. with movement | 5.7 score on a scale |
| Exparel Injectable Product | Post-operative Pain Intensity | 32hrs. at rest | 4.5942 score on a scale |
| Exparel Injectable Product | Post-operative Pain Intensity | 32hrs. with movement | 5.68 score on a scale |
| Exparel Injectable Product | Post-operative Pain Intensity | 40hrs. at rest | 4.5282 score on a scale |
| Exparel Injectable Product | Post-operative Pain Intensity | 40hrs. with movement | 5.66 score on a scale |
| Exparel Injectable Product | Post-operative Pain Intensity | 48hrs. at rest | 4.4622 score on a scale |
| Exparel Injectable Product | Post-operative Pain Intensity | 48hrs. with movement | 5.64 score on a scale |
| Exparel Injectable Product | Post-operative Pain Intensity | 60hrs. at rest | 4.3742 score on a scale |
| Exparel Injectable Product | Post-operative Pain Intensity | 60hrs. with movement | 5.61 score on a scale |
| Exparel Injectable Product | Post-operative Pain Intensity | 72hrs. at rest | 4.2862 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 24hrs. at rest | 4.86 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 48hrs. at rest | 4.656 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 4hrs. at rest | 5.03 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 24hrs. with movement | 6.44 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 4hrs. with movement | 6.64 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 60hrs. with movement | 6.04 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 8hrs. at rest | 4.996 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 32hrs. at rest | 4.792 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 8hrs. with movement | 6.6 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 48hrs. with movement | 6.16 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 12hrs. at rest | 4.962 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 32hrs. with movement | 6.32 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 12hrs. with movement | 6.56 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 72hrs. with movement | 5.92 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 16hrs. at rest | 4.928 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 40hrs. at rest | 4.724 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 16hrs. with movement | 6.52 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 60hrs. at rest | 4.554 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 20hrs. at rest | 4.894 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 40hrs. with movement | 6.24 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 20hrs. with movement | 6.48 score on a scale |
| Bupivacaine Hydrochloride | Post-operative Pain Intensity | 72hrs. at rest | 4.452 score on a scale |
Primary
Total Narcotic Consumption
All narcotics administered in the first 0-8, 8-24, 24-48, and 48-72 hours and the total narcotics administered in the 0-72 hours postoperative period(PCA narcotics, nurse-administered IV narcotics, and oral narcotics). All narcotics will be converted to total IV morphine equivalent for comparison between two groups.
Time frame: 0-72 hours post-operative period
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Exparel Injectable Product | Total Narcotic Consumption | 8-24 hours | 45 oral morphine equivalents in mg |
| Exparel Injectable Product | Total Narcotic Consumption | 48-72 hours | 15 oral morphine equivalents in mg |
| Exparel Injectable Product | Total Narcotic Consumption | 24-48 hours | 45 oral morphine equivalents in mg |
| Exparel Injectable Product | Total Narcotic Consumption | 0-72 hours | 139 oral morphine equivalents in mg |
| Exparel Injectable Product | Total Narcotic Consumption | 0-8 hours | 15 oral morphine equivalents in mg |
| Bupivacaine Hydrochloride | Total Narcotic Consumption | 0-72 hours | 105 oral morphine equivalents in mg |
| Bupivacaine Hydrochloride | Total Narcotic Consumption | 0-8 hours | 10 oral morphine equivalents in mg |
| Bupivacaine Hydrochloride | Total Narcotic Consumption | 8-24 hours | 34.5 oral morphine equivalents in mg |
| Bupivacaine Hydrochloride | Total Narcotic Consumption | 24-48 hours | 45 oral morphine equivalents in mg |
| Bupivacaine Hydrochloride | Total Narcotic Consumption | 48-72 hours | 26.5 oral morphine equivalents in mg |
Secondary
Hospital Readmission
Readmission to hospital will be noted
Time frame: From end of surgery assessed up to 30 days post-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exparel Injectable Product | Hospital Readmission | 3 Participants |
| Bupivacaine Hydrochloride | Hospital Readmission | 3 Participants |
Secondary
Length of Hospital and ICU Stay
Length of both hospital and ICU stay will be measured
Time frame: From date of surgery assessed up to 30 day post-operatively
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Exparel Injectable Product | Length of Hospital and ICU Stay | Length of ICU stay | 1.51 days |
| Exparel Injectable Product | Length of Hospital and ICU Stay | Length of postoperative hospital stay | 7 days |
| Bupivacaine Hydrochloride | Length of Hospital and ICU Stay | Length of ICU stay | 1.71 days |
| Bupivacaine Hydrochloride | Length of Hospital and ICU Stay | Length of postoperative hospital stay | 6 days |
Secondary
Major Organ Dysfunction
Organ systems such as cardiac, renal, respiratory, and nervous system failure/dysfunction in accordance with the Society of Thoracic Surgeon's database will be noted
Time frame: From date of surgery assessed up to 30 day post-operatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exparel Injectable Product | Major Organ Dysfunction | Renal failure / hemodialysis | 1 Participants |
| Exparel Injectable Product | Major Organ Dysfunction | Atrial fibrillation | 7 Participants |
| Exparel Injectable Product | Major Organ Dysfunction | Cardiac arrest | 0 Participants |
| Exparel Injectable Product | Major Organ Dysfunction | No major organ dysfunction | 20 Participants |
| Exparel Injectable Product | Major Organ Dysfunction | Pneumonia | 1 Participants |
| Bupivacaine Hydrochloride | Major Organ Dysfunction | No major organ dysfunction | 14 Participants |
| Bupivacaine Hydrochloride | Major Organ Dysfunction | Pneumonia | 0 Participants |
| Bupivacaine Hydrochloride | Major Organ Dysfunction | Renal failure / hemodialysis | 1 Participants |
| Bupivacaine Hydrochloride | Major Organ Dysfunction | Cardiac arrest | 1 Participants |
| Bupivacaine Hydrochloride | Major Organ Dysfunction | Atrial fibrillation | 15 Participants |
Secondary
Mortality
Mortality will be noted at specific timepoints
Time frame: From end of surgery assessed up to 30 days post-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exparel Injectable Product | Mortality | 0 Participants |
| Bupivacaine Hydrochloride | Mortality | 1 Participants |
Secondary
Non-invasive Ventilation (NIV) Requirement
Episodes of NIV such as upper airway masks or similar devices will be quantified
Time frame: From time of end of surgery to 72 hours post-operatively or until hospital discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exparel Injectable Product | Non-invasive Ventilation (NIV) Requirement | 6 Participants |
| Bupivacaine Hydrochloride | Non-invasive Ventilation (NIV) Requirement | 5 Participants |
Secondary
Patient Time to Mobilization
The time it takes until patient ambulates will be measured
Time frame: From time of end of surgery to time of mobilization up to 72 hours or discharge, *assessed up to 120 hours*
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Exparel Injectable Product | Patient Time to Mobilization | 42 hours |
| Bupivacaine Hydrochloride | Patient Time to Mobilization | 45 hours |
Secondary
Patient Time to Oral Intake
The time it takes until the patient is able to/medically cleared to consume food or liquid will be measured
Time frame: From time of end of surgery to time of oral intake up to 72 hours post-operatively or until hospital discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Exparel Injectable Product | Patient Time to Oral Intake | 7 hours |
| Bupivacaine Hydrochloride | Patient Time to Oral Intake | 5.6 hours |
Secondary
Patient Time to Out of Bed to Chair
The time it takes until the patient advances from bedrest to out of bed (OOB) to chair will be measured
Time frame: From time of end of surgery to time of mobilization up to 72 hours post-operatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Exparel Injectable Product | Patient Time to Out of Bed to Chair | 16 hours |
| Bupivacaine Hydrochloride | Patient Time to Out of Bed to Chair | 16 hours |
Secondary
Post-operative Nausea and Vomiting
Whether a patient experiences at least one episode of nausea and emesis will be measured
Time frame: From time of end of surgery to 72 hours post-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exparel Injectable Product | Post-operative Nausea and Vomiting | 3 Participants |
| Bupivacaine Hydrochloride | Post-operative Nausea and Vomiting | 9 Participants |
Secondary
Re-intubation
Instances of re-intubation will be recorded
Time frame: From time of end of surgery to patient discharge up to one week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exparel Injectable Product | Re-intubation | 3 Participants |
| Bupivacaine Hydrochloride | Re-intubation | 3 Participants |
Secondary
Time to Extubation
The time it takes until the patient is extubated post-operatively will be measured
Time frame: From the end of surgery until the patient is extubated up to 72 hours post-operatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Exparel Injectable Product | Time to Extubation | 3.85 hours |
| Bupivacaine Hydrochloride | Time to Extubation | 3.47 hours |
Secondary
Use of Incentive Spirometry
Frequency of incentive spirometry will be measured
Time frame: From time of end of surgery to 72 hours post-operatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Exparel Injectable Product | Use of Incentive Spirometry | 29 Participants |
| Bupivacaine Hydrochloride | Use of Incentive Spirometry | 31 Participants |
Other Pre-specified
Chronic Pain Assessment
Subjects will be asked the two following questions: Are you currently experiencing pain? as well as Are you experiencing moderate to severe pain? with moderate to severe indicated as a pain score of 4-10 on 0 to 10 scale, with 0 being no pain at all and 10 being the worst pain imaginable.
Time frame: 6 months after surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exparel Injectable Product | Chronic Pain Assessment | Any pain at 6 months | 9 Participants |
| Exparel Injectable Product | Chronic Pain Assessment | Moderate to severe pain at 6 months | 3 Participants |
| Exparel Injectable Product | Chronic Pain Assessment | No pain at 6 months | 17 Participants |
| Bupivacaine Hydrochloride | Chronic Pain Assessment | Any pain at 6 months | 14 Participants |
| Bupivacaine Hydrochloride | Chronic Pain Assessment | Moderate to severe pain at 6 months | 6 Participants |
| Bupivacaine Hydrochloride | Chronic Pain Assessment | No pain at 6 months | 11 Participants |
Other Pre-specified
Chronic Pain Assessment
Subjects will be asked the two following questions: Are you currently experiencing pain? as well as Are you experiencing moderate to severe pain? with moderate to severe indicated as a pain score of 4-10 on 0 to 10 scale, with 0 being no pain at all and 10 being the worst pain imaginable.
Time frame: 12 months after surgery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exparel Injectable Product | Chronic Pain Assessment | Any pain at 12 months | 7 Participants |
| Exparel Injectable Product | Chronic Pain Assessment | Moderate to severe pain at 12 months | 4 Participants |
| Exparel Injectable Product | Chronic Pain Assessment | No pain at 12 months | 18 Participants |
| Bupivacaine Hydrochloride | Chronic Pain Assessment | Any pain at 12 months | 12 Participants |
| Bupivacaine Hydrochloride | Chronic Pain Assessment | Moderate to severe pain at 12 months | 6 Participants |
| Bupivacaine Hydrochloride | Chronic Pain Assessment | No pain at 12 months | 13 Participants |
Other Pre-specified
Delirium
Patients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC)
Time frame: Assessment will be administered at 48 hours post-operatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exparel Injectable Product | Delirium | No delirium at 48 hours postoperatively | 18 Participants |
| Exparel Injectable Product | Delirium | Delirium at 48 hours postoperatively | 7 Participants |
| Exparel Injectable Product | Delirium | No delirium assessment conducted at 48 hours postoperatively | 4 Participants |
| Bupivacaine Hydrochloride | Delirium | No delirium at 48 hours postoperatively | 18 Participants |
| Bupivacaine Hydrochloride | Delirium | Delirium at 48 hours postoperatively | 7 Participants |
| Bupivacaine Hydrochloride | Delirium | No delirium assessment conducted at 48 hours postoperatively | 6 Participants |
Other Pre-specified
Delirium
Patients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC)
Time frame: Assessment will be administered at 72 hours post-operatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exparel Injectable Product | Delirium | No delirium at 72 hours postoperatively | 22 Participants |
| Exparel Injectable Product | Delirium | Subsyndromal delirium at 72 hours postoperatively | 4 Participants |
| Exparel Injectable Product | Delirium | Delirium at 72 hours postoperatively | 1 Participants |
| Exparel Injectable Product | Delirium | No delirium assessment conducted at 72 hours postoperatively | 2 Participants |
| Bupivacaine Hydrochloride | Delirium | No delirium assessment conducted at 72 hours postoperatively | 7 Participants |
| Bupivacaine Hydrochloride | Delirium | No delirium at 72 hours postoperatively | 21 Participants |
| Bupivacaine Hydrochloride | Delirium | Delirium at 72 hours postoperatively | 0 Participants |
| Bupivacaine Hydrochloride | Delirium | Subsyndromal delirium at 72 hours postoperatively | 3 Participants |
Other Pre-specified
Patient Satisfaction
Patient will give an assessment regarding pain management on a scale of 0 - 10 with 0 indicating the lowest satisfaction with pain management and 10 indicating the highest satisfaction with pain management
Time frame: Given at the time of discharge up to 30 days post-operatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Exparel Injectable Product | Patient Satisfaction | 10 score on a scale |
| Bupivacaine Hydrochloride | Patient Satisfaction | 10 score on a scale |
Other Pre-specified
Serum Cortisol Levels
Stress response suppression as a result of treatment will be evaluated by comparing hormone levels between the groups. Serum cortisol levels will be taken to measure this.
Time frame: Measured 8, 48, and 72 hours post-operatively
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Exparel Injectable Product | Serum Cortisol Levels | 8 hours postoperatively | 30 µg/dL |
| Exparel Injectable Product | Serum Cortisol Levels | 48 hours postoperatively | 15 µg/dL |
| Exparel Injectable Product | Serum Cortisol Levels | 72 hours postoperatively | 16 µg/dL |
| Bupivacaine Hydrochloride | Serum Cortisol Levels | 8 hours postoperatively | 36.5 µg/dL |
| Bupivacaine Hydrochloride | Serum Cortisol Levels | 48 hours postoperatively | 19 µg/dL |
| Bupivacaine Hydrochloride | Serum Cortisol Levels | 72 hours postoperatively | 17 µg/dL |