Clinical trial NCT03482973: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Sternal Pain
Keywords: Cardiopulmonary Bypass
Cardiac Surgery
Sternotomy
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Opioid Consumption
timeFrame: 48 hours
Secondary outcomes:
measure: Pain Scores
timeFrame: At 6-8 hourly intervals every day until discharge or 4 days
measure: ICU Length of Stay
timeFrame: Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days
measure: Hospital Length of Stay
timeFrame: Measured in days admitted in the hospital, an average of 5 days
measure: Number of Participants With Complications
timeFrame: 7 days post-op on an average
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Balachundhar Subramaniam
role: PRINCIPAL_INVESTIGATOR
References: