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

Sponsor

Wayne State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05003765

Collaborator

(none)

200

Enrollment

Location

Arms

20.8

Anticipated Duration (Months)

9.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Post-operative Pain Management	Drug: Bupivacaine 0.25% Injectable Solution Drug: Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg Drug: Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg, Buprenorphine 300 mcg	N/A

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, 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This study will consist of 4 arms (groups): Control Group (CTRL): No Block (Saline) Treatment Group1 (TRT1): SPIP Block with bupivacaine Treatment Group 2 (TRT2): SPIP Block with Bupivacaine +Magnesium as Adjuvant Treatment Group 3 (TRT3): SPIP Block with Bupivacaine +Magnesium + Buprenorphine both as Adjuvant Patients are assigned randomly to each group.This study will consist of 4 arms (groups):Control Group (CTRL): No Block (Saline) Treatment Group1 (TRT1): SPIP Block with bupivacaine Treatment Group 2 (TRT2): SPIP Block with Bupivacaine +Magnesium as Adjuvant Treatment Group 3 (TRT3): SPIP Block with Bupivacaine +Magnesium + Buprenorphine both as Adjuvant Patients are assigned randomly to each group.

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Supportive Care

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)?

Actual Study Start Date :

Aug 6, 2020

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Saline injection (CTRL) Arm 1- 50 Patients-Control Group (CTRL): No Block (Saline) Post-operatively patients will receive 20 mL of Saline (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.
Experimental: SPIP Block Arm 2-50 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.	Drug: Bupivacaine 0.25% Injectable Solution Injection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block.
Experimental: SPIP Block + Magnesium Arm 3-50 Patients-Post-operatively patients will receive bilateral SPIP blocks by injecting 20 mL of 0.25% bupivacaine + 200mg of magnesium sulfate (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.	Drug: 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.
Experimental: SPIP Block + Magnesium + Buprenorphine Arm 4-50 Patients-Post-operatively patients will receive bilateral SPIP blocks by injecting 20 mL of 0.25% bupivacaine+ 200mg of magnesium sulfate + buprenorphine (300mcg) (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.	Drug: 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.

Outcome Measures

Primary Outcome Measures

Post-operative total opioid consumption (oral morphine equivalents) [24 hours after the surgery]
Total Opioid consumption 24 hours post surgery oral moral morphine equivalents
Visual analog scale (VAS) pain scores [6 hours after surgery]
Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
Visual analog scale (VAS) pain scores [12 hours after surgery]
Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
Visual analog pain (VAS) scores [24 hours after surgery]
Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
Length of hospital stay (LOS) [Up to 1 month]
The days spent in the hospital from surgery to discharge

Secondary Outcome Measures

Incidence of post-operation nausea and vomiting (PONV) [24 hours]
The percentage of the patients who had post-operative nausea and vomiting (PONV) within 24 hours of surgery
Acetaminophen consumption [24 hours]
Total acetaminophen consumption in mg 24 hr after surgery
NSAID (ketorolac) consumption [24 hours after surgery]
Total NSAID consumption in mg
Length of ICU stay [Up to 1 month]
Length of stay in Intensive Care Unit from surgery to discharge from Intensive Care Unit
Time to extubation [24 Hours]
Time it took for patient to be extubated

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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