Recruiting

SPIP Blocks with Bupivacaine

Sponsor:

Wayne State University

Code:

NCT05003765

Conditions

Post-operative Pain Management

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT05003765

Start date

Aug 6, 2020

Status verified date

Aug, 2021

Completion date

May 1, 2022

Anticipated

Primary completion date

May 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

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.

Primary outcome measure

  • Post-operative total opioid consumption (oral morphine equivalents) [ Time Frame: 24 hours after the surgery ]
  • Visual analog scale (VAS) pain scores [ Time Frame: 6 hours after surgery ]
  • Visual analog scale (VAS) pain scores [ Time Frame: 12 hours after surgery ]
  • Visual analog pain (VAS) scores [ Time Frame: 24 hours after surgery ]
  • Length of hospital stay (LOS) [ Time Frame: Up to 1 month ]

Central Contacts and Locations

Central contacts

Sandeep H Krishnan, MD

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

Farhad Ghoddoussi, PhD

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

Locations

St. Joseph Mercy Oakland Hospital

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Lena Anderson

248-858-6068LeAnders@med.wayne.edu

More Information

Sponsor

Wayne State University

Last update posted

Aug 12, 2021

Last verified

Aug, 2021

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wayne State University on 2021-08-12.