Pecto-Intercostal Fascial Plane Block Study

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04928339
• Other study ID #: 2021-0111
• Secondary ID: Protocol Version
• Status: Completed
• Phase: Phase 4
• Start date: March 28, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: January 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 30, 2023
• Est. primary completion date: September 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Surgery
• Opioid Use, Unspecified

Intervention

Drug:
• Bupivacaine Injection
10mL of 0.25% bupivacaine
• Liposomal bupivacaine
15mL of 133mg liposomal bupivacaine

Other:
• Saline
25mL saline control

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Opioid Consumption 72 hours postoperatively	Total opioid consumption during the initial 72 hours postoperatively will be measured in morphine equivalents and compared between groups.	up to 72 hours post-op
Secondary	Total Intraoperative Opioid Consumption	Total intraoperative opioid consumption will be measured in morphine equivalents and compared between groups.	intraoperative
Secondary	Daily Mean Pain Scores first 72 hours Postoperatively	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.	up to 72 hours post-op
Secondary	Maximum Pain Scores up to 72 hours Postoperatively	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, beginning at time 0 (arrival to ICU). Maximum pain scores will be compared between groups.	up to 72 hours post-op
Secondary	Pain Score at 90 days Postoperatively	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.	up to 90 days post-op
Secondary	Daily Opioid Consumption up to 72 hours Postoperatively	Daily opioid consumption during the initial 72 hours postoperatively will be measured in morphine equivalents and compared between groups.	up to 72 hours post-op
Secondary	Hours of Mechanical Ventilation after ICU admission	Duration of mechanical ventilation will be measured by hours of mechanical ventilation after admission to the ICU.	up to 72 hours post-op
Secondary	Number of postoperative days until the first Bowel Movement	Return of bowel function will be measured in the number of postoperative days until the first bowel movement.	up to 72 hours post-op
Secondary	Incidence of Postoperative Delirium per the Confusion Assessment Method for the ICU (CAM-ICU)	Postoperative delirium 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.	up to 72 hours post-op
Secondary	Number of Hours that the Patient is in the ICU	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.	up to 72 hours post-op
Secondary	Number of post-operative days until the Patient is Discharged	Duration of hospital stay will be measured by the number of post-operative days until the patient is discharged.	up to 7 days
Secondary	Number of Participants Using Opioids at 90 days Postoperatively	Patient use of opioids at 90 days will be obtained by phone call.	up to 90 days post-op