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

NCT05003765 | Unknown

• 1 other identifier: SPIP_Block
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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)

Conditions

Post-operative Pain Management

Keywords

coronary artery bypass grafting, superficial parasternal intercostal plane block , opioid consumption, magnesium, buprenorphine

Outcome Measures

Primary Outcomes (5)

• Post-operative total opioid consumption (oral morphine equivalents)

  Total Opioid consumption 24 hours post surgery oral moral morphine equivalents

  24 hours after the 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 pain (VAS) 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 Outcomes (5)

• Incidence of post-operation nausea and vomiting (PONV)

  24 hours

• Acetaminophen consumption

  24 hours

• NSAID (ketorolac) consumption

  24 hours after surgery

• Length of ICU stay

  Up to 1 month

• Time to extubation

  24 Hours

Study Arms (4)

Saline injection (CTRL)

NO INTERVENTION

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.

SPIP Block

EXPERIMENTAL

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

SPIP Block + Magnesium

EXPERIMENTAL

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

SPIP Block + Magnesium + Buprenorphine

EXPERIMENTAL

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

Interventions

Bupivacaine 0.25% Injectable Solution DRUG

Injection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block.

SPIP Block

Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg DRUG

Injection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block. Addition of 200mg of magnesium sulfate as adjuvant.

SPIP Block + Magnesium

Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg, Buprenorphine 300 mcg DRUG

Injection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block. Addition of 200mg of magnesium sulfate and 300 mcg buprenorphine as adjuvants.

SPIP Block + Magnesium + Buprenorphine

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing primary coronary artery bypass grafting

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

St. Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States

RECRUITING

MeSH Terms

Interventions

Bupivacaine; Magnesium Sulfate; Buprenorphine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Sandeep H Krishnan, MD

CONTACT

(248) 858-6068; sakrishna@med.wayne.edu

Farhad Ghoddoussi, PhD

CONTACT

(248) 858-6068; fghoddoussi@med.wayne.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor of Anesthesiology

Model Details: 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.

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 12, 2021
• Study Start: August 6, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)