CompletedNCT03270514Updated Sep 5, 2021Results posted

Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride

A Phase 3 interventional study of Exparel Injectable Product and Bupivacaine Hydrochloride in Coronary Artery Disease, Coronary Artery Stenoses and Valve Regurgitation, Mitral, sponsored by Kathirvel Subramaniam. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-05.

Sponsored by Kathirvel Subramaniam · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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

Read the 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.

Conditions studied

Coronary Artery Disease
Coronary Artery Stenoses
Valve Regurgitation, Mitral
Valve Regurgitation, Tricuspid

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Keywords

cardiac surgery
sternotomy
post-operative pain
sternal wound infiltration

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts 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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 60 participants (actual)

Study arms

Experimental
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).
Drug: Exparel Injectable Product
Active comparator
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).
Drug: Bupivacaine Hydrochloride

Interventions

DrugExparel 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)
Also known as: Liposomal Bupivacaine
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)
Also known as: Bupivacaine

What researchers measure

Primary outcomes

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
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

Secondary outcomes

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
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*
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
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
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
Re-intubation
Instances of re-intubation will be recorded
Time frame: From time of end of surgery to patient discharge up to one week
Use of Incentive Spirometry
Frequency of incentive spirometry will be measured
Time frame: From time of end of surgery to 72 hours post-operatively
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
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
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
Hospital Readmission
Readmission to hospital will be noted
Time frame: From end of surgery assessed up to 30 days post-operatively
Mortality
Mortality will be noted at specific timepoints
Time frame: From end of surgery assessed up to 30 days post-operatively

Other outcomes

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
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
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
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
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
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

Results

Posted Sep 5, 2021

Participant flow

Participant flow — Overall Study
Milestone	Exparel Injectable Product	Bupivacaine Hydrochloride
Started	29	31
Completed	29	31
Not completed	0	0

Outcome measures

PrimaryPost-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
Reported as:: Mean · score on a scale

Post-operative Pain Intensity
score on a scale	Exparel Injectable Product	Bupivacaine Hydrochloride
4hrs. at rest	4.7482 (0 to 10)	5.03 (0 to 10)
4hrs. with movement	5.75 (0 to 10)	6.64 (0 to 10)
8hrs. at rest	4.7262 (0 to 10)	4.996 (0 to 10)
8hrs. with movement	5.74 (0 to 10)	6.6 (0 to 10)
12hrs. at rest	4.7042 (0 to 10)	4.962 (0 to 10)
12hrs. with movement	5.73 (0 to 10)	6.56 (0 to 10)
16hrs. at rest	4.6822 (0 to 10)	4.928 (0 to 10)
16hrs. with movement	5.72 (0 to 10)	6.52 (0 to 10)
20hrs. at rest	4.6602 (0 to 10)	4.894 (0 to 10)
20hrs. with movement	5.71 (0 to 10)	6.48 (0 to 10)
24hrs. at rest	4.6382 (0 to 10)	4.86 (0 to 10)
24hrs. with movement	5.7 (0 to 10)	6.44 (0 to 10)
32hrs. at rest	4.5942 (0 to 10)	4.792 (0 to 10)
32hrs. with movement	5.68 (0 to 10)	6.32 (0 to 10)
40hrs. at rest	4.5282 (0 to 10)	4.724 (0 to 10)
40hrs. with movement	5.66 (0 to 10)	6.24 (0 to 10)
48hrs. at rest	4.4622 (0 to 10)	4.656 (0 to 10)
48hrs. with movement	5.64 (0 to 10)	6.16 (0 to 10)
60hrs. at rest	4.3742 (0 to 10)	4.554 (0 to 10)
60hrs. with movement	5.61 (0 to 10)	6.04 (0 to 10)
72hrs. at rest	4.2862 (0 to 10)	4.452 (0 to 10)
72hrs. with movement	5.58 (0 to 10)	5.92 (0 to 10)

PrimaryTotal 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
Reported as:: Median · oral morphine equivalents in mg

Total Narcotic Consumption
oral morphine equivalents in mg	Exparel Injectable Product	Bupivacaine Hydrochloride
0-8 hours	15 (7.5 to 30)	10 (0 to 19)
8-24 hours	45 (30 to 60)	34.5 (15 to 52.5)
24-48 hours	45 (10 to 75)	45 (12 to 67.5)
48-72 hours	15 (2.5 to 53)	26.5 (5 to 45)
0-72 hours	139 (73 to 212)	105 (54.5 to 188)

SecondaryTime 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
Reported as:: Median · hours

Time to Extubation
hours	Exparel Injectable Product	Bupivacaine Hydrochloride
Time to Extubation	3.85 (2.65 to 8.17)	3.47 (2.49 to 9.58)

SecondaryPatient 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*
Reported as:: Median · hours

Patient Time to Mobilization
hours	Exparel Injectable Product	Bupivacaine Hydrochloride
Patient Time to Mobilization	42 (19 to 51)	45 (33 to 78)

SecondaryPatient 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
Reported as:: Median · hours

Patient Time to Out of Bed to Chair
hours	Exparel Injectable Product	Bupivacaine Hydrochloride
Patient Time to Out of Bed to Chair	16 (11 to 19)	16 (8 to 20)

SecondaryPatient 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
Reported as:: Median · hours

Patient Time to Oral Intake
hours	Exparel Injectable Product	Bupivacaine Hydrochloride
Patient Time to Oral Intake	7 (5 to 18)	5.6 (4.0 to 18)

SecondaryNon-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
Reported as:: Count of participants · Participants

Non-invasive Ventilation (NIV) Requirement
Participants	Exparel Injectable Product	Bupivacaine Hydrochloride
Non-invasive Ventilation (NIV) Requirement	6	5

SecondaryRe-intubation

Instances of re-intubation will be recorded

Time frame:: From time of end of surgery to patient discharge up to one week
Reported as:: Count of participants · Participants

Re-intubation
Participants	Exparel Injectable Product	Bupivacaine Hydrochloride
Re-intubation	3	3

SecondaryUse of Incentive Spirometry

Frequency of incentive spirometry will be measured

Time frame:: From time of end of surgery to 72 hours post-operatively
Reported as:: Count of participants · Participants

Use of Incentive Spirometry
Participants	Exparel Injectable Product	Bupivacaine Hydrochloride
Use of Incentive Spirometry	29	31

SecondaryPost-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
Reported as:: Count of participants · Participants

Post-operative Nausea and Vomiting
Participants	Exparel Injectable Product	Bupivacaine Hydrochloride
Post-operative Nausea and Vomiting	3	9

SecondaryMajor 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
Reported as:: Count of participants · Participants

Major Organ Dysfunction
Participants	Exparel Injectable Product	Bupivacaine Hydrochloride
Pneumonia	1	0
Renal failure / hemodialysis	1	1
Cardiac arrest	0	1
Atrial fibrillation	7	15
No major organ dysfunction	20	14

SecondaryLength 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
Reported as:: Median · days

Length of Hospital and ICU Stay
days	Exparel Injectable Product	Bupivacaine Hydrochloride
Length of ICU stay	1.51 (1.08 to 2.11)	1.71 (1.11 to 2.97)
Length of postoperative hospital stay	7 (5.5 to 8)	6 (5 to 7.3)

SecondaryHospital Readmission

Readmission to hospital will be noted

Time frame:: From end of surgery assessed up to 30 days post-operatively
Reported as:: Count of participants · Participants

Hospital Readmission
Participants	Exparel Injectable Product	Bupivacaine Hydrochloride
Hospital Readmission	3	3

SecondaryMortality

Mortality will be noted at specific timepoints

Time frame:: From end of surgery assessed up to 30 days post-operatively
Reported as:: Count of participants · Participants

Mortality
Participants	Exparel Injectable Product	Bupivacaine Hydrochloride
Mortality	0	1

Other pre-specifiedDelirium

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
Reported as:: Count of participants · Participants

Delirium
Participants	Exparel Injectable Product	Bupivacaine Hydrochloride
No delirium at 48 hours postoperatively	18	18
Delirium at 48 hours postoperatively	7	7
No delirium assessment conducted at 48 hours postoperatively	4	6

Other pre-specifiedDelirium

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
Reported as:: Count of participants · Participants

Delirium
Participants	Exparel Injectable Product	Bupivacaine Hydrochloride
No delirium at 72 hours postoperatively	22	21
Subsyndromal delirium at 72 hours postoperatively	4	3
Delirium at 72 hours postoperatively	1	0
No delirium assessment conducted at 72 hours postoperatively	2	7

Other pre-specifiedPatient 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
Reported as:: Median · score on a scale

Patient Satisfaction
score on a scale	Exparel Injectable Product	Bupivacaine Hydrochloride
Patient Satisfaction	10 (8 to 10)	10 (9 to 10)

Other pre-specifiedChronic 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
Reported as:: Count of participants · Participants

Chronic Pain Assessment
Participants	Exparel Injectable Product	Bupivacaine Hydrochloride
Any pain at 6 months	9	14
Moderate to severe pain at 6 months	3	6
No pain at 6 months	17	11

Other pre-specifiedChronic Pain Assessment

Time frame:: 12 months after surgery
Reported as:: Count of participants · Participants

Chronic Pain Assessment
Participants	Exparel Injectable Product	Bupivacaine Hydrochloride
Any pain at 12 months	7	12
Moderate to severe pain at 12 months	4	6
No pain at 12 months	18	13

Other pre-specifiedSerum 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
Reported as:: Median · µg/dL

Serum Cortisol Levels
µg/dL	Exparel Injectable Product	Bupivacaine Hydrochloride
8 hours postoperatively	30 (23 to 40)	36.5 (27 to 49)
48 hours postoperatively	15 (11 to 20)	19 (14 to 24)
72 hours postoperatively	16 (11 to 18)	17 (13 to 22)

Adverse events

Collected over from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Exparel Injectable Product	1/29 (3.4%)	5/29 (17.2%)	3/29 (10.3%)
Bupivacaine Hydrochloride	1/31 (3.2%)	5/31 (16.1%)	5/31 (16.1%)

Most frequent serious events

Most frequent serious events
Event	Exparel Injectable Product	Bupivacaine Hydrochloride
Respiratory FailureRespiratory, thoracic and mediastinal disorders	2/29	1/31
PneumothoraxRespiratory, thoracic and mediastinal disorders	1/29	0/31
SeizureNervous system disorders	1/29	0/31
Cardiac ArrestCardiac disorders	1/29	1/31
Pulmonary ArrestRespiratory, thoracic and mediastinal disorders	0/29	1/31
Hypotension requiring aortic balloon pumpCardiac disorders	0/29	1/31
Vasodilatory ShockVascular disorders	0/29	1/31

Most frequent other events

Most frequent other events
Event	Exparel Injectable Product	Bupivacaine Hydrochloride
Respiratory InsufficiencyRespiratory, thoracic and mediastinal disorders	2/29	2/31
Pulmonary InsufficiencyRespiratory, thoracic and mediastinal disorders	1/29	0/31
Atrial EctopyCardiac disorders	0/29	1/31
HypoxiaBlood and lymphatic system disorders	0/29	1/31
Atrial fibrillationCardiac disorders	0/29	1/31

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Exparel Injectable Product	Bupivacaine Hydrochloride	Total
Median	67 (60 to 72)	65 (60 to 72)	65.5 (60 to 72)

Sex: Female, Male
Sex: Female, Male(Participants)	Exparel Injectable Product	Bupivacaine Hydrochloride	Total
Female	5	5	10
Male	24	26	50

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Exparel Injectable Product	Bupivacaine Hydrochloride	Total
Hispanic or Latino	0	0	0
Not Hispanic or Latino	29	28	57
Unknown or Not Reported	0	3	3

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Exparel Injectable Product	Bupivacaine Hydrochloride	Total
American Indian or Alaska Native	0	0	0
Asian	2	0	2
Native Hawaiian or Other Pacific Islander	1	0	1
Black or African American	0	0	0
White	26	28	54
More than one race	0	0	0
Unknown or Not Reported	0	3	3

Body Mass Index
Body Mass Index(kg/m^2)	Exparel Injectable Product	Bupivacaine Hydrochloride	Total
Median	32 (29.4 to 34)	31.3 (28.7 to 33.1)	31.7 (29.2 to 33.6)

Diabetes mellitus
Diabetes mellitus(Participants)	Exparel Injectable Product	Bupivacaine Hydrochloride	Total
Count of participants	15	14	29

Hypertension
Hypertension(Participants)	Exparel Injectable Product	Bupivacaine Hydrochloride	Total
Count of participants	27	28	55

Congestive heart failure
Congestive heart failure(Participants)	Exparel Injectable Product	Bupivacaine Hydrochloride	Total
Count of participants	5	5	10

20 further baseline measures are reported on the registry.

Study locations

1 site

UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania 15213, United States

References and documents

Publications

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Study documents

Protocol and statistical analysis plan · Dec 6, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03270514
Lead sponsor: Kathirvel Subramaniam
Collaborators: Pacira Pharmaceuticals, Inc
Responsible party: Kathirvel Subramaniam (Principal Investigator, Associate Professor, University of Pittsburgh) — Sponsor-investigator
First posted: Sep 1, 2017
Start date: Nov 15, 2018
Primary completion: Dec 13, 2019
Completion: Feb 25, 2020
Results posted: Sep 5, 2021
Last update: Sep 5, 2021

Study contacts

Kathirvel Subramaniam, MD, MPH

principal investigator · Associate Professor and staff Anesthesiologist

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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Discussion

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