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Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03482973
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Balachundhar Subramaniam, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Sternal Pain Drug: Bupivacaine Group Other: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
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
Other: Placebo
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 Measures :
  1. Opioid consumption [ Time Frame: 48 hours ]
    Total opioid consumption in the first 48 hours post-operatively


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Balachundhar Subramaniam, MD, MPH 617-634-2721 bsubrama@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Balachundhar Subramaniam, MD    617-754-2675    bsubrama@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Balachundhar Subramaniam Beth Israel Deaconess Medical Center

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Responsible Party: Balachundhar Subramaniam, Associate Professor of Anesthesia, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03482973    
Other Study ID Numbers: 2018P000044
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Balachundhar Subramaniam, Beth Israel Deaconess Medical Center:
Cardiopulmonary Bypass
Cardiac Surgery
Sternotomy
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents