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

Primary Purpose

Post-operative Pain Management

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine 0.25% Injectable Solution
Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg
Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg, Buprenorphine 300 mcg
Sponsored by
Wayne State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post-operative Pain Management focused on measuring coronary artery bypass grafting, superficial parasternal intercostal plane block , opioid consumption, magnesium, buprenorphine

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • St. Joseph Mercy Oakland HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Saline injection (CTRL)

SPIP Block

SPIP Block + Magnesium

SPIP Block + Magnesium + Buprenorphine

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 29, 2021
Last Updated
August 11, 2021
Sponsor
Wayne State University
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1. Study Identification

Unique Protocol Identification Number
NCT05003765
Brief Title
Are Superficial Parasternal Intercostal Plane (SPIP) Blocks With Bupivacaine and With or Without Adjuvants Helpful for Post-operative Pain After Coronary Artery Bypass Grafting?
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)?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 6, 2020 (Actual)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain Management
Keywords
coronary artery bypass grafting, superficial parasternal intercostal plane block , opioid consumption, magnesium, buprenorphine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saline injection (CTRL)
Arm Type
No Intervention
Arm Description
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.
Arm Title
SPIP Block
Arm Type
Experimental
Arm Description
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.
Arm Title
SPIP Block + Magnesium
Arm Type
Experimental
Arm Description
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.
Arm Title
SPIP Block + Magnesium + Buprenorphine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25% Injectable Solution
Intervention Description
Injection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg
Intervention Description
Injection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block. Addition of 200mg of magnesium sulfate as adjuvant.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg, Buprenorphine 300 mcg
Intervention Description
Injection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block. Addition of 200mg of magnesium sulfate and 300 mcg buprenorphine as adjuvants.
Primary Outcome Measure Information:
Title
Post-operative total opioid consumption (oral morphine equivalents)
Description
Total Opioid consumption 24 hours post surgery oral moral morphine equivalents
Time Frame
24 hours after the surgery
Title
Visual analog scale (VAS) pain scores
Description
Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
Time Frame
6 hours after surgery
Title
Visual analog scale (VAS) pain scores
Description
Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
Time Frame
12 hours after surgery
Title
Visual analog pain (VAS) scores
Description
Pain Scores measured via a Visual Analog Scale (0-10, Higher scores mean worse outcome)
Time Frame
24 hours after surgery
Title
Length of hospital stay (LOS)
Description
The days spent in the hospital from surgery to discharge
Time Frame
Up to 1 month
Secondary Outcome Measure Information:
Title
Incidence of post-operation nausea and vomiting (PONV)
Description
The percentage of the patients who had post-operative nausea and vomiting (PONV) within 24 hours of surgery
Time Frame
24 hours
Title
Acetaminophen consumption
Description
Total acetaminophen consumption in mg 24 hr after surgery
Time Frame
24 hours
Title
NSAID (ketorolac) consumption
Description
Total NSAID consumption in mg
Time Frame
24 hours after surgery
Title
Length of ICU stay
Description
Length of stay in Intensive Care Unit from surgery to discharge from Intensive Care Unit
Time Frame
Up to 1 month
Title
Time to extubation
Description
Time it took for patient to be extubated
Time Frame
24 Hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandeep H Krishnan, MD
Phone
(248) 858-6068
Email
sakrishna@med.wayne.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Farhad Ghoddoussi, PhD
Phone
(248) 858-6068
Email
fghoddoussi@med.wayne.edu
Facility Information:
Facility Name
St. Joseph Mercy Oakland Hospital
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lena Anderson
Phone
248-858-6068
Email
LeAnders@med.wayne.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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