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Are Superficial Parasternal Intercostal Plane (SPIP) Blocks With Bupivacaine and With or Without Transversus Abdominis Plane Block (TAP) Helpful for Post-operative Pain After Coronary Artery Bypass Grafting?

Are Superficial Parasternal Intercostal Plane (SPIP) Blocks With Transversus Abdominis Plane (TAP) Block More Helpful Than SPIP Blocks Alone in Managing Post-operative Pain in Coronary Artery Bypass Grafting (CABG)?

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05090735
Enrollment
100
Registered
2021-10-25
Start date
2021-11-30
Completion date
2022-11-30
Last updated
2021-10-25

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

Conditions

Post-operative Pain Management

Keywords

coronary artery bypass grafting, superficial parasternal intercostal plane block , transversus abdominis plane block, opioid consumption

Brief summary

The purpose of this study is to determine whether superficial parasternal intercostal plane (SPIP) block alone or with transverses abdominis plane (TAP) block can improve post-operative pain in patients undergoing cardiothoracic surgery, specifically, coronary artery bypass grafting (CABG).

Detailed description

Postoperative pain management remains an important clinical challenge in cardiothoracic surgery. Inadequate postoperative pain control can have adverse pathophysiologic consequences, including increased myocardial oxygen demand, hypoventilation, suboptimal clearance of pulmonary secretions, acute respiratory failure, and decreased mobility, with associated increased risks for formation of clots in a blood vessels (thromboembolism). These adverse events may result in greater perioperative morbidity and mortality. Despite several multimodal approaches to postoperative pain control, optimal pain management after cardiothoracic procedures remains an issue. Regional anesthesia is used to block sensation in a specific part of body during and after surgery. It offers numerous advantages over conventional general anesthesia, including faster recovery time, fewer side effects, no need for an airway device during surgery, and a dramatic reduction in post-surgical pain and reduction in opioid use following surgery. The use of local anesthetic peripheral nerve blocks for surgical anesthesia and postoperative pain management has increased significantly with the advent of ultrasound-guided techniques. Ultrasound has revolutionized regional anesthesia by allowing real-time visualization of anatomical structures, needle advancement and local anesthetic (LA) spread. This has led not only to refinement of existing techniques, but also the introduction of new ones. In particular, ultrasound has been critical in the development of fascial plane blocks, in which local anesthetic (LA) is injected into a tissue plane rather than directly around nerves. These blocks are believed to work via passive spread of LA to nerves traveling within that tissue plane, or to adjacent tissue compartments containing nerves. Although research into these techniques is still at an early stage, the available evidence indicates that they are effective in reducing opioid requirements and improving the pain experience in a wide range of clinical settings. They are best employed as part of multimodal analgesia with other systemic analgesics, rather than as sole anesthetic techniques. Catheters may be beneficial in situations where moderate-severe pain is expected for \>12 hours, although the optimal dosing regimen requires further investigation. In this study the investigators will focus on the superficial parasternal-intercostal plane (SPIP) block and the transverses abdomens plane (TAP) block. The investigators will compare the SPIP block administered alone and with a TAP block; the investigators will measure the visual analog scale (VAS) pain scores in the first 24 hours after surgery, total post-operative opioid consumption (oral morphine equivalents), total acetaminophen and ketorolac consumption, post-operative nausea and vomiting (PONV), length of the ICU stay, time to extubation, and length of hospital stay to determine if one technique is superior to the other.

Interventions

PROCEDURESPIP and TAP Block

Injection of Bupivacaine 0.25% for SPIP Block and TAP Block.

PROCEDURESPIP Block

Injection of Bupivacaine 0.25% for SPIP Block

Sponsors

Wayne State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

\- Patients undergoing primary coronary artery bypass grafting

Exclusion criteria

* Patients with significant genetic or acquired clotting/bleeding disorders (hemophilia, DIC, etc.) * Patients with significant platelet dysfunction * Infection at site for regional anesthesia * Allergy to local anesthetics * Severe aortic stenosis * Severe mitral stenosis * Sepsis

Design outcomes

Primary

MeasureTime frameDescription
Post-operative total opioid consumption (oral morphine equivalents)24 hours after surgeryTotal Opioid consumption 24 hours post surgery oral moral morphine equivalents
Visual analog scale (VAS) pain scores6 hours after surgeryPain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
Length of hospital stay (LOS)Up to 1 monthThe days spent in the hospital from surgery to discharge

Secondary

MeasureTime frameDescription
Length of ICU stayUp to 1 monthLength of stay in Intensive Care Unit from surgery to discharge from Intensive Care Unit
Incidence of post-operation nausea and vomiting (PONV)24 hoursThe percentage of the patients who had post-operative nausea and vomiting (PONV) within 24 hours of surgery
Time to extubation24 hoursTime it took for patient to be extubated
Acetaminophen consumption24 hours after surgeryTotal acetaminophen consumption in mg 24 hr after surgery
NSAID (ketorolac) consumption24 hours after surgeryTotal NSAID consumption in mg

Contacts

Primary ContactSandeep Krishnan, M.D.
sakrishna@med.wayne.edu(248) 858-6068

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026