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?

Post-operative Pain Management Clinical Trial

Official title:

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)?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05090735
• Other study ID #: SPIP and TAP in CABG
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2021
• Est. completion date: November 2022

Study information

• Verified date: October 2021
• Source: Wayne State University
• Contact: Sandeep Krishnan, M.D.
• Phone: (248) 858-6068
• Email: sakrishna[@]med.wayne.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain Management

Intervention

Procedure:
• SPIP and TAP Block
Injection of Bupivacaine 0.25% for SPIP Block and TAP Block.
• SPIP Block
Injection of Bupivacaine 0.25% for SPIP Block

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative total opioid consumption (oral morphine equivalents)	Total Opioid consumption 24 hours post surgery oral moral morphine equivalents	24 hours after surgery
Primary	Visual analog scale (VAS) pain scores	Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)	6 hours after surgery
Primary	Visual analog scale (VAS) pain scores	Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)	12 hours after surgery
Primary	Visual analog scale (VAS) pain scores	Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)	24 hours after surgery
Primary	Length of hospital stay (LOS)	The days spent in the hospital from surgery to discharge	Up to 1 month
Secondary	Incidence of post-operation nausea and vomiting (PONV)	The percentage of the patients who had post-operative nausea and vomiting (PONV) within 24 hours of surgery	24 hours
Secondary	Acetaminophen consumption	Total acetaminophen consumption in mg 24 hr after surgery	24 hours after surgery
Secondary	NSAID (ketorolac) consumption	Total NSAID consumption in mg	24 hours after surgery
Secondary	Length of ICU stay	Length of stay in Intensive Care Unit from surgery to discharge from Intensive Care Unit	Up to 1 month
Secondary	Time to extubation	Time it took for patient to be extubated	24 hours