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)?

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Post-operative Pain Management
• Intervention / Treatment: Procedure: SPIP Block; Procedure: SPIP and TAP Block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandeep Krishnan, M.D.; Phone Number: (248) 858-6068; Email: sakrishna@med.wayne.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SPIP Block; 50 Patients-Post-operatively patients will receive bilateral SPIP blocks by injecting 20 mL of 0.25% bupivacaine (on each side) between the pectoralis major and external intercostal muscle aponeurosis at 2 cm lateral to the right and left of the sternal edge, corresponding to the fifth rib.	Procedure: SPIP Block; Injection of Bupivacaine 0.25% for SPIP Block
Active Comparator: SPIP Block with TAP Block; 50 Patients-Post-operatively patients will receive bilateral SPIP blocks by injecting 20 mL of 0.25% bupivacaine (on each side) between the pectoralis major and external intercostal muscle aponeurosis at 2 cm lateral to the right and left of the sternal edge, corresponding to the fifth rib. This group of patients will also receive unilateral TAP block by injecting 20 mL of 0.25% bupivacaine in the plane between the internal oblique and transversus abdominis muscles.	Procedure: SPIP and TAP Block; Injection of Bupivacaine 0.25% for SPIP Block and TAP Block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative total opioid consumption (oral morphine equivalents)	Total Opioid consumption 24 hours post surgery oral moral morphine equivalents	24 hours after surgery
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
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
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
Length of hospital stay (LOS)	The days spent in the hospital from surgery to discharge	Up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Acetaminophen consumption	Total acetaminophen consumption in mg 24 hr after surgery	24 hours after surgery
NSAID (ketorolac) consumption	Total NSAID consumption in mg	24 hours after surgery
Length of ICU stay	Length of stay in Intensive Care Unit from surgery to discharge from Intensive Care Unit	Up to 1 month
Time to extubation	Time it took for patient to be extubated	24 hours

Collaborators and Investigators

• Sponsor: Wayne State University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: coronary artery bypass grafting, superficial parasternal intercostal plane block , transversus abdominis plane block, opioid consumption
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: SPIP and TAP in CABG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No