Pecto-Intercostal Fascial Block for Postoperative Analgesia After Cardiac Surgery

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03482973
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.2
• Patients Per Site Per Month: 4.6

Study Details

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.

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.

Study Design

• Study Type: Interventional
• Actual 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: Jun 21, 2018
• Actual Primary Completion Date: Nov 25, 2019
• Actual Study Completion Date: Nov 27, 2019

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

1. Opioid Consumption [48 hours]

   Total opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME).

Secondary Outcome Measures

1. Pain Scores [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. 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.

2. ICU Length of Stay [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 [Measured in days admitted in the hospital, an average of 5 days]

   Their stay in the hospital for the index admission

4. Number of Participants With Complications [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Beth Israel Deaconess Medical Center

Investigators

• Principal Investigator: Balachundhar Subramaniam, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

• Informed Consent Form - Jan 28, 2019
• Study Protocol and Statistical Analysis Plan - Apr 9, 2019

More Information

Publications

None provided.

• Responsible Party: Balachundhar Subramaniam, Associate Professor of Anesthesia, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT03482973
• Other Study ID Numbers: 2018P000044
• First Posted: Mar 29, 2018
• Last Update Posted: Aug 3, 2020
• Last Verified: Jul 1, 2020

• 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
• Keywords provided by Balachundhar Subramaniam, Associate Professor of Anesthesia, Beth Israel Deaconess Medical Center: Cardiopulmonary Bypass; Cardiac Surgery; Sternotomy
• Additional relevant MeSH terms: Coronary Artery Disease; Bupivacaine

Study Results

Participant Flow

Pre-assignment Detail	80 Participants signed consent and none of the participants was withdrawn prior to randomization.

Arm/Group Title	Interventional Bupivacaine	Interventional Placebo
Arm/Group Description	20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1 Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).	20 cc of saline on each side of the sternum at two time points after surgery and POD1 Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
Period Title: Overall Study
STARTED	40	40
COMPLETED	40	40
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Interventional Bupivacaine	Interventional Placebo	Total
Arm/Group Description	20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1 Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).	20 cc of saline on each side of the sternum at two time points after surgery and POD1 Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).	Total of all reporting groups
Overall Participants	40	40	80
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.78 (8.73)	65.70 (9.86)	65.73 (9.25)
Sex: Female, Male (Count of Participants)
Female	13 32.5%	6 15%	19 23.8%
Male	27 67.5%	34 85%	61 76.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2.5%	0 0%	1 1.3%
Not Hispanic or Latino	31 77.5%	27 67.5%	58 72.5%
Unknown or Not Reported	8 20%	13 32.5%	21 26.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 2.5%	0 0%	1 1.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	33 82.5%	32 80%	65 81.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	6 15%	8 20%	14 17.5%
Region of Enrollment (participants) [Number]
United States	40 100%	40 100%	80 100%
Weight (Kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg]	86.53 (18.44)	85.55 (15.10)	86.04 (16.75)
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	173.73 (12.08)	172.02 (9.96)	172.88 (11.03)
Body Mass Index (BMI) (Kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg/m^2]	28.57 (5.10)	28.92 (4.84)	28.74 (4.94)
Preoperative comorbidities (participants) [Number]
None	0 0%	5 12.5%	5 6.3%
Peripheral vascular disease	2 5%	6 15%	8 10%
Connective tissue disease	0 0%	0 0%	0 0%
Ulcer disease	2 5%	4 10%	6 7.5%
Mild Liver disease	0 0%	0 0%	0 0%
Diabetes without complications	7 17.5%	8 20%	15 18.8%
Diabetes with end organ damage	4 10%	5 12.5%	9 11.3%
Hemiplegia	0 0%	0 0%	0 0%
Moderate or severe renal disease	5 12.5%	6 15%	11 13.8%
Solid tumor (Non-metastatic)	7 17.5%	6 15%	13 16.3%
Solid tumor (Metastatic)	0 0%	2 5%	2 2.5%
Acquired immunodeficiency syndrome (AIDS)	1 2.5%	0 0%	1 1.3%
Chronic pain	8 20%	6 15%	14 17.5%
Hypertension	31 77.5%	27 67.5%	58 72.5%
Hyperlipidemia	29 72.5%	23 57.5%	52 65%
Leukemia	0 0%	0 0%	0 0%
Lymphoma or multiple myeloma	0 0%	0 0%	0 0%
Moderate or severe liver disease	1 2.5%	0 0%	1 1.3%
Congestive heart failure	4 10%	4 10%	8 10%
Arrhythmia	6 15%	7 17.5%	13 16.3%
Coagulopathy	0 0%	0 0%	0 0%
Hypercoagulability	1 2.5%	1 2.5%	2 2.5%
Obesity	2 5%	2 5%	4 5%
Chronic obstructive pulmonary disease(COPD)/Asthma	6 15%	3 7.5%	9 11.3%
Surgical characteristics (Count of Participants)
Isolated Coronary artery bypass grafting (CABG)	22 55%	26 65%	48 60%
CABG surgery + additional surgery	3 7.5%	5 12.5%	8 10%
Valve surgery	14 35%	8 20%	22 27.5%
Other	1 2.5%	1 2.5%	2 2.5%
Past surgical history (participants) [Number]
None	25 62.5%	23 57.5%	48 60%
Cardiac surgery	2 5%	3 7.5%	5 6.3%
Coronary artery stenting	9 22.5%	6 15%	15 18.8%
Vascular surgery	0 0%	4 10%	4 5%
Open abdominal surgery	5 12.5%	5 12.5%	10 12.5%

Outcome Measures

1. Primary Outcome

Title	Opioid Consumption
Description	Total opioid consumption in the first 48 hours post-operatively, measured as milligram morphine equivalents (MME).
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interventional Bupivacaine	Interventional Placebo
Arm/Group Description	20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1 Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).	20 cc of saline on each side of the sternum at two time points after surgery and POD1 Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
Measure Participants	40	40
Mean (Standard Deviation) [Milligram Morphine Equivalents (MME)]	40.8 (22.4)	49.1 (26.9)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interventional Bupivacaine	Interventional Placebo
Arm/Group Description	20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1 Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).	20 cc of saline on each side of the sternum at two time points after surgery and POD1 Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
Measure Participants	40	40
Mean (Standard Deviation) [score on a scale]	4.8 (2.7)	5.1 (2.6)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interventional Bupivacaine	Interventional Placebo
Arm/Group Description	20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1 Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).	20 cc of saline on each side of the sternum at two time points after surgery and POD1 Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
Measure Participants	40	40
Median (Inter-Quartile Range) [days]	1.2	1.7

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interventional Bupivacaine	Interventional Placebo
Arm/Group Description	20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1 Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).	20 cc of saline on each side of the sternum at two time points after surgery and POD1 Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
Measure Participants	40	40
Median (Inter-Quartile Range) [days]	8	7.5

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interventional Bupivacaine	Interventional Placebo
Arm/Group Description	20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1 Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).	20 cc of saline on each side of the sternum at two time points after surgery and POD1 Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
Measure Participants	40	40
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	All adverse events will be assessed daily during the hospital stay for a maximum of 4 postoperative days
Adverse Event Reporting Description	Anticipated and unanticipated deaths, serious adverse events, and other adverse events due to any cause, whether related or unrelated to study procedures.
Arm/Group Title	Interventional Bupivacaine		Interventional Placebo
Arm/Group Description	20 cc of 0.25% bupivacaine on each side of the sternum at two time points after surgery and POD1 Bupivacaine Group: 20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).		20 cc of saline on each side of the sternum at two time points after surgery and POD1 Placebo: 20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
All Cause Mortality
	Interventional Bupivacaine		Interventional Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		1/40 (2.5%)
Serious Adverse Events
	Interventional Bupivacaine		Interventional Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		1/40 (2.5%)
Infections and infestations
Abdominal Sepsis	0/40 (0%)	0	1/40 (2.5%)	1
Other (Not Including Serious) Adverse Events
	Interventional Bupivacaine		Interventional Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)

Limitations/Caveats

This is a single-center study with restrictive inclusion may place some limitations on generalizability.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.