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PainPhase 4NCT05589363

ABC Blocks for Cardiac Surgery

A Phase 4 study testing ABC block with bupivacaine/liposomal bupivacaine and ABC block with saline in people with Pain, run by Duke University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Pain
What is being tested?
ABC block with bupivacaine/liposomal bupivacaine and ABC block with saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Nov 2024to Jul 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Duke University Hospital

    Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: A Comparison of the Analgesic Effects of Rectus Sheath and Transversus Thoracis Plane Blocks (ABC Blocks) Versus Saline Injection for Median Sternotomy: a Prospective, Randomized Controlled Trial.

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.

Read the detailed description

Subjects will be randomized on the morning of surgery to receive either "anterior blocks for cardiac surgery" or "ABC blocks" using 60 mL of local anesthetic mixture (20 mL of liposomal bupivacaine plus 40 mL of 0.25% bupivacaine) or a sham saline ABC block (60 mL). All subjects will receive standard of care anesthetic regimen for their cardiac surgery at the discretion of his/her attending anesthesiologist. 40 mL of the solution will be administered in the parasternal intercostal space, and 20 mL will be placed in the rectus sheath in the epigastric region.

For the parasternal blocks, a linear high frequency ultrasound probe will be placed parasagitally at the T2-3 level approximately 3cm lateral to the mid-sternum, and all relevant structures will be identified, including the pectoralis major muscle, internal intercostal muscle, ribs, pleura, and any vasculature, including the internal mammary artery and vein. Color Doppler will be used confirm the location of vasculature.

After skin local anesthetic infiltration, a 10 cm 21G insulated block needle (Sonoplex, Pajunk Medical Systems, Norcross, GA) will be inserted from the inferior aspect of the ultrasound probe in a caudal to cranial direction and aligned with the ultrasound scanning plane (in-plane approach). In this way, both the needle shaft and tip can be visualized as the needle approaches the plane between the pectus major and intercostal muscles. The needle will be redirected as needed. Once satisfactory position of the needle time is confirmed and after frequent negative aspiration, 10 mL of study solution will be slowly injected. This injection will be repeated at the T4-5 interspace. Spread of local anesthetic will be documented in the appropriate plane in real time. This procedure will be performed bilaterally.

For the rectus sheath blocks, a linear high frequency ultrasound probe will be placed in a transverse position in the midline, just inferior to the xiphoid process. The probe will be moved laterally to visualize the lateral edge of the rectus abdominis muscle. A 10 cm 21G insulated block needle will be inserted from the lateral aspect of the ultrasound probe in a lateral to medial direction until visualized deep to the muscle immediately adjacent to the posterior rectus sheath. After negative aspiration, 10 mL of study solution will be slowly injected into this plane. This procedure will then be repeated on the contralateral side

All nerve blocks will be performed by a trainee supervised by an anesthesiologist experienced in regional anesthesia. The anesthesiology team and in the OR will be blinded to group allocation.

Subjects will receive a general anesthetic consistent with standard of care for cardiac surgeries at the discretion of his/her attending anesthesiologist. At the conclusion of the case, subjects will be extubated and/or transported to the ICU intubated. The decision to extubate the subject in the OR will be made at the discretion of the attending anesthesiologist.

Evaluation of acute postoperative pain intensity using a 0-10 visual analog scale (VAS) and opioid consumption will be undertaken at the following time points:

  • 24 hours postoperatively
  • 48 hours postoperatively Review of the medical chart will be made post-operatively to gather other data, including total intraoperative oral morphine equivalent consumption, cumulative opioid consumption at 48 hours, time to tracheal extubation, ICU length of stay, hospital length of stay, and time to first session with physical therapy. Occurrences of any adverse events reported by the subject or medical team will also be collected.
Conditions
Pain
Being tested
ABC block with bupivacaine/liposomal bupivacaine, ABC block with saline
Keywords
Anesthesia, Heart surgery, Pain management
Medical subject headings
Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABC block with bupivacaine/liposomal bupivacaineDrug

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

  • ABC block with salineDrug

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

Study groups in NCT05589363
Study groupRoleWhat they receive
ABC block with bupivacaine and liposomal bupivacaineActive comparatorThe 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).
Receives: Drug: ABC block with bupivacaine/liposomal bupivacaine
ABC block with salineSham comparatorThe 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).
Receives: Drug: ABC block with saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative opioid consumption from extubation to 24 hours post-extubation

    Morphine equivalents administered between extubation and 24 hours post-extubation

    Measured: Extubation to 24 hr post-extubation

Secondary outcomes (8)
  1. Worst pain at rest at 2 hours post-extubation

    Pain intensity as measured on Numeric Pain Rating Scale (NRS-11) at 2 hours post-extubation. The NRS-11 ranges from '0' (no pain) to '10' (worst pain imaginable).

    Measured: 2 hours post-extubation

  2. Worst pain at rest at 6 hours post-extubation

    Pain intensity as measured on Numeric Pain Rating Scale (NRS-11) at 6 hours post-extubation. The NRS-11 ranges from '0' (no pain) to '10' (worst pain imaginable).

    Measured: 6 hours post-extubation

  3. Worst pain at rest at 24 hours post-extubation

    Pain intensity as measured on Numeric Pain Rating Scale (NRS-11) at 24 hours post-extubation. The NRS-11 ranges from '0' (no pain) to '10' (worst pain imaginable).

    Measured: 24 hours post-extubation

  4. Worst pain at rest at 48 hours post-extubation

    Pain intensity as measured on Numeric Pain Rating Scale (NRS-11) at 48 hours post-extubation. The NRS-11 ranges from '0' (no pain) to '10' (worst pain imaginable).

    Measured: 48 hours post-extubation

  5. Cumulative opioid consumption from extubation to 48 hours post-extubation

    Morphine equivalents administered between extubation and 48 hours post-extubation

    Measured: Extubation to 48 hr post-extubation

  6. Time from end of case to tracheal extubation

    Time from end of surgical case (as defined by nursing record) until tracheal extubation

    Measured: End of operative case until patient extubated, up to 24 hours

  7. ICU length of stay

    Duration of time spent in cardiothoracic ICU from admission to discharge

    Measured: Postoperative from admission to ICU to discharge to floor, approximately 3 days

  8. Time to first session of physical therapy (PT)

    Time from ICU admission until first session of physical therapy

    Measured: 0-48 hours after surgical procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2022
  2. Study startNov 2024 (estimated)
  3. Primary completionJul 2025 (estimated)
  4. Study completionJul 2025 (estimated)

Why it stopped: Budgetary issues

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05589363
Sponsor's protocol ID
Pro00104058
Status last verified
Mar 2024
First submitted
28 Sep 2022
Last updated
27 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ABC block with bupivacaine/liposomal bupivacaine and ABC block with saline in people with Pain, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative opioid consumption from extubation to 24 hours post-extubation (time frame: Extubation to 24 hr post-extubation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.

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