Pecto-Intercostal Fascial Plane Block Study

Pecto-Intercostal Fascial Plane Block for Enhanced Recovery After Cardiac Surgery

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04928339

Enrollment

100

Registered

2021-06-16

Start date

2022-03-28

Completion date

2023-11-30

Last updated

2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Opioid Use, Unspecified

Brief summary

This study is being done to see if bilateral pecto-intercostal fascial plane blocks (PIFB) with a mixture of liposomal and standard bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). 100 participants will be recruited and can expect to be on study for 100 days.

Detailed description

Thousands of heart surgeries are performed every day in the United States. Unattenuated perioperative pain has been shown to contribute to increased morbidity, mortality, length of stay, and healthcare costs. Practice guidelines from the American Society of Regional Anesthesiologists recommend pre-incision techniques to reduce perioperative pain, however in cardiac surgery, there are no commonly used techniques to follow this recommendation. The PIFB is a newly described fascial plane block and existing literature supports the safety and efficacy of the PIFB in cardiac surgery patients. However, there are no randomized controlled trials evaluating this technique with a long-acting depot local anesthetic. The purpose of this study is to determine whether bilateral pecto-intercostal fascial plane blocks with liposomal bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). The primary hypothesis is that patients receiving effective regional anesthesia with liposomal bupivacaine via PIFB will demonstrate a clinically significant (25%) reduction in total daily opioid consumption through 72 hours postoperatively compared to patients receiving standard of care without effective regional anesthesia (saline only via PIFB). This study is a prospective, single-center, randomized, double-blind, controlled trial to evaluate whether bilateral pecto-intercostal fascial plane blocks with liposomal and standard bupivacaine decrease pain and opioid requirements in patients undergoing cardiac surgery via median sternotomy compared to controls (sham blocks with saline). The participants will be randomized to receive bilateral PIFB with a mixture of standard and liposomal bupivacaine or bilateral PIFB with saline only. Recovery characteristics, including opioid consumption, pain scores, duration of mechanical ventilation, ICU length of stay, hospital length of stay, side effects, and chronic opioid use will be evaluated.

Interventions

DRUGBupivacaine Injection

10mL of 0.25% bupivacaine

DRUGLiposomal bupivacaine

15mL of 133mg liposomal bupivacaine

OTHERSaline

25mL saline control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Caregiver)

Masking description

Each study participant and OR anesthesia team, cardiac surgery team, cardiothoracic ICU team, and nursing staff caring for the participant will be blinded to the study drug the patient received. However, the anesthesia provider performing the block (separate from the provider caring for the patient in the operating room) will not be blinded to the study drug injected and will have access to all monitors deemed appropriate by the primary team caring for the participant.

Intervention model description

prospective, single-center, randomized, double-blind, controlled trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Participant provides consent to participate in study * Ideal body weight (IBW) is \>50kg * Participant is planned to undergo coronary artery bypass graft or single valve repair/replacement surgery via median sternotomy * Participant is undergoing an elective procedure

Exclusion criteria

* Participant is unable or unwilling to give consent * Non-English speaking * Known or believed to be pregnant or is currently breastfeeding * Participant is a prisoner * Clinically unstable per discretion of the Investigator * Participant requires urgent/emergent surgery * History of previous sternotomy * Preoperative coagulopathy (INR \>1.4, platelets \<100,000) or ongoing anticoagulation or anti-platelet therapy (except aspirin 81mg) * Allergy or sensitivity to amide-type local anesthetics, dexmedetomidine or ketamine * Participant has decompensated heart failure * Severe left ventricle dysfunction (defined quantitatively as an ejection fraction of less than or equal to 35%) or right ventricle dysfunction (defined qualitatively as severe) * Diagnosis of cirrhosis or end-stage liver disease * Requires the use of mechanical circulatory support pre-operatively * Participant uses chronic opioids (meaning at the time of the preoperative screening evaluation by the study team, the patient is prescribed and taking any opioid pain medication)

Design outcomes

Primary

Measure	Time frame	Description
Total Opioid Consumption 72 Hours Post-operatively	up to 72 hours post-operatively	Total opioid consumption during the initial 72 hours post-operatively will be measured in morphine milligram equivalents (MME) and compared between groups.

Secondary

Measure	Time frame	Description
Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	data collected immediately post-op, 24 hours, 48 hours, and 72 hours post-operatively	Pain will be assessed, according to standard of care, every 4 hours using the 11-point Numerical Rating Scale (NRS), beginning at time 0 (arrival to ICU). Each patient's pain scores (higher scores indicate worse pain) within each postoperative day will be averaged, and the mean pain scores during each day and throughout the first 72 hours will be compared between the intervention and control groups. Median pain scores at 24, 48 and 72 hours post-op will be interrogated. Participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-10).
Maximum Pain Scores up to 72 Hours Postoperatively	up to 72 hours post-op	Pain will be assessed, according to standard of care, every 4 hours using the 9-point Numerical Rating Scale (NRS) where higher score indicate worse pain, beginning at time 0 (arrival to ICU). The number of Participants reporting a Maximum pain score at 72 hours postoperatively will be reported. Participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-9).
Pain Score at 90 Days Postoperatively	up to 90 days post-op	Pain will be assessed, according to standard of care, every 4 hours using the 11-point Numerical Rating Scale (NRS) where higher score indicate worse pain. Pain at 90 days postoperative will be surveyed by phone. Pain will be assessed participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-10).
Daily Opioid Consumption up to 72 Hours Postoperatively	up to 72 hours post-op	Daily opioid consumption during the initial 72 hours postoperatively will be measured in milligrams of morphine equivalents and compared between groups.
Hours of Mechanical Ventilation After ICU Admission	up to 72 hours post-op	Duration of mechanical ventilation will be measured by hours of mechanical ventilation after admission to the ICU.
Total Intraoperative Opioid Consumption	intraoperative period ranging from anesthesia start time to anesthesia end time	Total intraoperative opioid consumption will be measured in morphine milligram equivalents (MME) and compared between groups.
Number of Participants Reporting Postoperative Delirium Episodes Per the Confusion Assessment Method for the ICU (CAM-ICU)	up to 72 hours post-op	Postoperative delirium episodes will be measured according to standard of care by utilizing the CAM-ICU assessment every 8-12 hours. The CAM-ICU determines either 'yes' or 'no' the participant is experiencing delirium. The number of of delirium episodes within 72 hours post-op will be determined.
Number of Hours That the Patient is in the ICU	up to 72 hours post-op	Duration of ICU stay will be measured by the number of hours that the patient is in the ICU until an order is placed for transfer to a lower level of care.
Number of Post-operative Days Until the Patient is Discharged	Up to 7 days	Duration of hospital stay will be measured by the number of post-operative days until the patient is discharged.
Count of Participants Using Opioids at 90 Days Postoperatively	up to 90 days post-op	Patient use of opioids at 90 days will be obtained by phone call.
Number of Postoperative Days Until the First Bowel Movement	up to 72 hours post-op	Return of bowel function will be measured in the number of postoperative days until the first bowel movement.

Countries

United States

Participant flow

Recruitment details

Participants were enrolled at UW Hospitals and Clinics from March 2022 until September 2023

Participants by arm

Arm	Count
PIFB Intervention bilateral PIFB with a mixture of standard 0.25% bupivacaine (15 mL) and 133 mg liposomal bupivacaine (10mL) Bupivacaine Injection: 10mL of 0.25% bupivacaine Liposomal bupivacaine: 15mL of 133mg liposomal bupivacaine	50
Saline Control bilateral PIFB with 25 mL saline only Saline: 25mL saline control	50
Total	100

Baseline characteristics

Characteristic	PIFB Intervention	Total	Saline Control
Age, Continuous	65.50 years	64 years	64.00 years
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants	9 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants	68 Participants	33 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants	23 Participants	15 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	7 Participants	9 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants	23 Participants	15 Participants
Race (NIH/OMB) White	35 Participants	68 Participants	33 Participants
Region of Enrollment United States	50 participants	100 participants	50 participants
Sex: Female, Male Female	14 Participants	21 Participants	7 Participants
Sex: Female, Male Male	36 Participants	79 Participants	43 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 50	0 / 50
other Total, other adverse events	0 / 50	0 / 50
serious Total, serious adverse events	0 / 50	0 / 50

Outcome results

Primary

Total Opioid Consumption 72 Hours Post-operatively

Total opioid consumption during the initial 72 hours post-operatively will be measured in morphine milligram equivalents (MME) and compared between groups.

Time frame: up to 72 hours post-operatively

Arm	Measure	Value (MEDIAN)
PIFB Intervention	Total Opioid Consumption 72 Hours Post-operatively	165.00 morphine milligram equivalents
Saline Control	Total Opioid Consumption 72 Hours Post-operatively	205.05 morphine milligram equivalents

Secondary

Count of Participants Using Opioids at 90 Days Postoperatively

Patient use of opioids at 90 days will be obtained by phone call.

Time frame: up to 90 days post-op

Arm	Measure	Value (NUMBER)
PIFB Intervention	Count of Participants Using Opioids at 90 Days Postoperatively	2 count of participants
Saline Control	Count of Participants Using Opioids at 90 Days Postoperatively	1 count of participants

Secondary

Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op

Pain will be assessed, according to standard of care, every 4 hours using the 11-point Numerical Rating Scale (NRS), beginning at time 0 (arrival to ICU). Each patient's pain scores (higher scores indicate worse pain) within each postoperative day will be averaged, and the mean pain scores during each day and throughout the first 72 hours will be compared between the intervention and control groups. Median pain scores at 24, 48 and 72 hours post-op will be interrogated. Participants described their pain as low (range of 0-4), medium (range of 5-7) or high (range of 8-10).

Time frame: data collected immediately post-op, 24 hours, 48 hours, and 72 hours post-operatively

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
PIFB Intervention	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median Pain at 72 hours post-operatively	low pain	46 Participants
PIFB Intervention	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median Pain at 72 hours post-operatively	medium pain	2 Participants
PIFB Intervention	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median Pain at 72 hours post-operatively	high pain	2 Participants
PIFB Intervention	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median pain scores at 48 hours post-operatively post-op	low pain	3 Participants
PIFB Intervention	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median pain scores at 48 hours post-operatively post-op	medium pain	19 Participants
PIFB Intervention	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median pain scores at 48 hours post-operatively post-op	high pain	28 Participants
PIFB Intervention	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median pain scores at 24 hours post-operatively	low pain	2 Participants
PIFB Intervention	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median pain scores at 24 hours post-operatively	medium pain	17 Participants
PIFB Intervention	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median pain scores at 24 hours post-operatively	high pain	31 Participants
PIFB Intervention	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median Pain immediately post-operatively	low pain	2 Participants
PIFB Intervention	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median Pain immediately post-operatively	medium pain	7 Participants
PIFB Intervention	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median Pain immediately post-operatively	high pain	41 Participants
Saline Control	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median Pain immediately post-operatively	medium pain	7 Participants
Saline Control	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median Pain at 72 hours post-operatively	low pain	47 Participants
Saline Control	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median pain scores at 24 hours post-operatively	low pain	2 Participants
Saline Control	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median Pain at 72 hours post-operatively	medium pain	1 Participants
Saline Control	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median Pain immediately post-operatively	low pain	0 Participants
Saline Control	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median Pain at 72 hours post-operatively	high pain	2 Participants
Saline Control	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median pain scores at 24 hours post-operatively	medium pain	16 Participants
Saline Control	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median pain scores at 48 hours post-operatively post-op	low pain	4 Participants
Saline Control	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median Pain immediately post-operatively	high pain	43 Participants
Saline Control	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median pain scores at 48 hours post-operatively post-op	medium pain	22 Participants
Saline Control	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median pain scores at 24 hours post-operatively	high pain	32 Participants
Saline Control	Daily Median Pain Scores First 72 Hours Postoperatively Number of Participants Experiencing Low, Medium or High Pain for up to 72 Hours Post-op	Median pain scores at 48 hours post-operatively post-op	high pain	24 Participants

Secondary

Daily Opioid Consumption up to 72 Hours Postoperatively

Daily opioid consumption during the initial 72 hours postoperatively will be measured in milligrams of morphine equivalents and compared between groups.