Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery

Coronary Artery Disease Clinical Trial

Official title:

Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03482973
• Other study ID #: 2018P000044
• Status: Completed
• Phase: Phase 3
• Start date: June 21, 2018
• Est. completion date: November 27, 2019

Study information

• Verified date: July 2020
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 27, 2019
• Est. primary completion date: November 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Sternal Pain

Intervention

Drug:
• Bupivacaine Group
20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).

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).

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Consumption	Total opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME).	48 hours
Secondary	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.	At 6-8 hourly intervals every day until discharge or 4 days
Secondary	ICU Length of Stay	Total duration of stay in ICU for the index admission	Time of ICU admission until time of discharge to hospital floor; through the hospital stay, an average of 5 days
Secondary	Hospital Length of Stay	Their stay in the hospital for the index admission	Measured in days admitted in the hospital, an average of 5 days
Secondary	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	7 days post-op on an average