ABC Blocks for Cardiac Surgery

NCT05589363 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: Pro00104058
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized blinded trial aims to evaluate the effect of parasternal intercostal and rectus sheath blocks ("anterior blocks for cardiac surgery" or ABC blocks) on postoperative recovery in patients undergoing median sternotomy for cardiac surgery. Subjects will be randomized to receive either local anesthetic (liposomal bupivacaine plus bupivacaine 0.25%) or saline sham block.

Conditions

Pain

Keywords

Anesthesia; Heart surgery; Pain management

Outcome Measures

Primary Outcomes (1)

• Cumulative opioid consumption from extubation to 24 hours post-extubation

  Morphine equivalents administered between extubation and 24 hours post-extubation

  Extubation to 24 hr post-extubation

Secondary Outcomes (8)

• Worst pain at rest at 2 hours post-extubation

  2 hours post-extubation

• Worst pain at rest at 6 hours post-extubation

  6 hours post-extubation

• Worst pain at rest at 24 hours post-extubation

  24 hours post-extubation

• Worst pain at rest at 48 hours post-extubation

  48 hours post-extubation

• Cumulative opioid consumption from extubation to 48 hours post-extubation

  Extubation to 48 hr post-extubation

Study Arms (2)

ABC block with bupivacaine and liposomal bupivacaine

ACTIVE COMPARATOR

The study solution used in the active arm will comprise 20 mL of liposomal bupivacaine (266 mg) admixed with 40 mL of 0.25% bupivacaine HCl. The solution will be administered as bilateral parasternal blocks (40 mL) and bilateral epigastric rectus sheath blocks (20 mL).

Drug: ABC block with bupivacaine/liposomal bupivacaine

ABC block with saline

SHAM COMPARATOR

The study solution used in the active arm will comprise 60 mL of 0.9% saline. The solution will be administered as bilateral parasternal blocks (40 mL) and bilateral epigastric rectus sheath blocks (20 mL).

Drug: ABC block with saline

Interventions

ABC block with bupivacaine/liposomal bupivacaine DRUG

Patients will be randomized to receive an ABC block using bupivacaine/liposomal bupivacaine solution

ABC block with bupivacaine and liposomal bupivacaine

ABC block with saline DRUG

Patients will be randomized to receive an ABC block using normal saline

ABC block with saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects scheduled for elective cardiac surgery involving primary median sternotomy
• Age 18-85 years of age
• BMI 18-50 kg/m2

You may not qualify if:

• Left ventricular ejection fraction (LVEF) \< 30%
• Preoperative, intraoperative, or immediate post-operative placement of intra-aortic balloon pump or deployment of extra-corporeal membrane oxygenation (ECMO)
• Inability to understand or speak English
• Allergy to amide local anesthetic
• Contraindication to peripheral nerve block (e.g. local infection, previous trauma to the block site)
• Chronic opioid consumption (daily oral morphine equivalent of \>20 mg) in the past three months
• Severe pulmonary disease
• Neurological deficit or disorder
• Suspected or known addition to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past two years
• Uncontrolled anxiety, schizophrenia, or other severe psychiatric disorder

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Michael Manning, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 21, 2022
• Study Start: November 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 27, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)