Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT03482973|
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : March 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Sternal Pain||Drug: Bupivacaine Group Other: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery|
|Actual Study Start Date :||June 21, 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: Interventional Bupivacaine
20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1
Drug: Bupivacaine Group
20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).
Placebo Comparator: Interventional Placebo
20 cc of saline on each side of the sternum at two time points after surgery and POD1
20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
- Opioid consumption [ Time Frame: 48 hours ]Total opioid consumption in the first 48 hours post-operatively
- Pain scores [ Time Frame: At 6-8 hourly intervals every day until discharge or 4 days ]Patient reported pain scores on a scale from 0-10 until discharge for the index admission
- ICU length of stay [ Time Frame: Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days ]Total duration of stay in ICU for the index admission
- Hospital length of stay [ Time Frame: Measured in days admitted in the hospital, an average of 5 days ]Their stay in the hospital for the index admission
- Incidence of complications [ Time Frame: 7 days post-op on an average ]This includes infection, hematoma, local anesthetic systemic toxicity directly related to the block or the drug used in the block
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482973
|Contact: Balachundhar Subramaniam, MD, MPHfirstname.lastname@example.org|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Balachundhar Subramaniam, MD 617-754-2675 email@example.com|
|Principal Investigator:||Balachundhar Subramaniam||Beth Israel Deaconess Medical Center|