Are Superficial Parasternal Intercostal Plane (SPIP) Blocks With Bupivacaine and With or Without Adjuvants 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 Local Anesthetic Alone and Local Anesthetic With Adjuvants Helpful in Managing Post-operative Pain in Coronary Artery Bypass Grafting (CABG)?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05003765
• Other study ID #: SPIP_Block
• Status: Recruiting
• Phase: N/A
• Start date: August 6, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: August 2021
• Source: Wayne State University
• Contact: Sandeep H Krishnan, MD
• 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 the addition of the superficial parasternal intercostal plane (SPIP) block alone (30cc of 0.25% bupivacaine) or plus Magnesium (200mg of magnesium sulfate) or plus Magnesium + Buprenorphine (300mcg) as adjuvants 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, which is among the anteromedial chest wall (near sternum) blocks and was first performed by Raza et al. and Ohgoshi et al.

The investigators will be assessing whether the addition of SPIP block (alone or plus adjuvants) will decrease the visual analog scale (VAS) pain scores in the first 24 hours after surgery, decrease post-operative total opioid consumption (oral morphine equivalents), decrease total acetaminophen and ketorolac consumption, decrease post-operative nausea and vomiting (PONV), decrease length of the ICU stay, decrease time to extubation, and decrease length of hospital stay in comparison to when SPIP block is not administered.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 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

Drug:
• Bupivacaine 0.25% Injectable Solution
Injection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block.
• Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg
Injection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block. Addition of 200mg of magnesium sulfate as adjuvant.
• Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg, Buprenorphine 300 mcg
Injection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block. Addition of 200mg of magnesium sulfate and 300 mcg buprenorphine as adjuvants.

Locations

Country	Name	City	State
United States	St. Joseph Mercy Oakland Hospital	Pontiac	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

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 the 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 pain (VAS) 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
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