Back to resultsPecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery
Primary Purpose
Coronary Artery Disease, Sternal Pain
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine Group
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Cardiopulmonary Bypass, Cardiac Surgery, Sternotomy
Eligibility Criteria
Inclusion Criteria
- Patients 18 years of age or older
- Undergoing cardiac surgery with sternotomy, limited to CABG, CABG+valve surgeries and isolated valve surgeries.
Exclusion Criteria
- Current participation in another interventional study
- Preoperative LVEF < 30%
- Use of mechanical circulatory support
- Emergent procedures
- Aortic surgeries, transplants ventricular assist device insertions, bentall, or grafts
- Minimally invasive cardiac procedures or those with thoracotomy approach
- Patients receiving other modalities of regional anesthesia like intrathecal morphine
- Chronic opioid use for chronic pain conditions with tolerance (total daily dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year)
- Current use of TCA, gabapentin, or pregabalin
- Hypersensitivity to bupivacaine
- Women who are pregnant or breastfeeding
- Non English speaking
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Interventional Bupivacaine
Interventional Placebo
Arm Description
20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1
20 cc of saline on each side of the sternum at two time points after surgery and POD1
Outcomes
Primary Outcome Measures
Opioid Consumption
Total opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME).
Secondary Outcome Measures
Pain Scores
Patient reported pain scores on a scale from 0-10 until discharge for the index admission. Where the minimum score is 0 and, the maximum score is 10. A score of 0 means no pain and the higher the score, the greater the pain intensity, with a score of 10 means worse imaginable pain. Pain scores recorded at 6-8 hourly intervals every day until discharge or 4 days, computed as an average pain score.
ICU Length of Stay
Total duration of stay in ICU for the index admission
Hospital Length of Stay
Their stay in the hospital for the index admission
Number of Participants With Complications
This includes infection, hematoma, local anesthetic systemic toxicity directly related to the block or the drug used in the block
Full Information
NCT ID
NCT03482973
First Posted
March 5, 2018
Last Updated
July 29, 2020
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03482973
Brief Title
Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery
Official Title
Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 21, 2018 (Actual)
Primary Completion Date
November 25, 2019 (Actual)
Study Completion Date
November 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline.
Detailed Description
The purpose of this study is to determine whether administration of a pecto-intercostal fascial plane block (PIFB) with bupivacaine is a more effective therapy for postoperative analgesia after cardiac surgery as compared to patients who receive a sham block of normal saline.
Specific Aim 1: To determine whether or not a PIFB with bupivacaine can reduce postoperative pain after cardiac surgery. This will be assessed through:
(Aim 1A) opioid consumption in the first 48 hours postoperatively (Aim 1B) patient self-reported pain scores during their hospital stay
Specific Aim 2: To estimate the effect size in order to obtain information that can be used to power future research on the use of regional modalities of analgesia for cardiac surgeries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Sternal Pain
Keywords
Cardiopulmonary Bypass, Cardiac Surgery, Sternotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional Bupivacaine
Arm Type
Experimental
Arm Description
20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1
Arm Title
Interventional Placebo
Arm Type
Placebo Comparator
Arm Description
20 cc of saline on each side of the sternum at two time points after surgery and POD1
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Group
Intervention Description
20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
Primary Outcome Measure Information:
Title
Opioid Consumption
Description
Total opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME).
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Pain Scores
Description
Patient reported pain scores on a scale from 0-10 until discharge for the index admission. Where the minimum score is 0 and, the maximum score is 10. A score of 0 means no pain and the higher the score, the greater the pain intensity, with a score of 10 means worse imaginable pain. Pain scores recorded at 6-8 hourly intervals every day until discharge or 4 days, computed as an average pain score.
Time Frame
At 6-8 hourly intervals every day until discharge or 4 days
Title
ICU Length of Stay
Description
Total duration of stay in ICU for the index admission
Time Frame
Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days
Title
Hospital Length of Stay
Description
Their stay in the hospital for the index admission
Time Frame
Measured in days admitted in the hospital, an average of 5 days
Title
Number of Participants With Complications
Description
This includes infection, hematoma, local anesthetic systemic toxicity directly related to the block or the drug used in the block
Time Frame
7 days post-op on an average
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients 18 years of age or older
Undergoing cardiac surgery with sternotomy, limited to CABG, CABG+valve surgeries and isolated valve surgeries.
Exclusion Criteria
Current participation in another interventional study
Preoperative LVEF < 30%
Use of mechanical circulatory support
Emergent procedures
Aortic surgeries, transplants ventricular assist device insertions, bentall, or grafts
Minimally invasive cardiac procedures or those with thoracotomy approach
Patients receiving other modalities of regional anesthesia like intrathecal morphine
Chronic opioid use for chronic pain conditions with tolerance (total daily dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year)
Current use of TCA, gabapentin, or pregabalin
Hypersensitivity to bupivacaine
Women who are pregnant or breastfeeding
Non English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Balachundhar Subramaniam
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery
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