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?

NCT05090735 | Unknown

• 1 other identifier: SPIP and TAP in CABG
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Post-operative Pain Management

Keywords

coronary artery bypass grafting, superficial parasternal intercostal plane block , transversus abdominis plane block, opioid consumption

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 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 Outcomes (5)

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

  24 hours

• Acetaminophen consumption

  24 hours after surgery

• NSAID (ketorolac) consumption

  24 hours after surgery

• Length of ICU stay

  Up to 1 month

• Time to extubation

  24 hours

Study Arms (2)

SPIP Block

ACTIVE COMPARATOR

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

SPIP Block with TAP Block

ACTIVE COMPARATOR

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

Interventions

SPIP and TAP Block PROCEDURE

Injection of Bupivacaine 0.25% for SPIP Block and TAP Block.

SPIP Block with TAP Block

SPIP Block PROCEDURE

Injection of Bupivacaine 0.25% for SPIP Block

SPIP Block

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

Central Study Contacts

Sandeep Krishnan, M.D.

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 25, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share