Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-25 @ 9:15 PM
Study NCT ID:
NCT04788056
Status:
WITHDRAWN
Last Update Posted:
2025-11-26
First Post:
2021-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Parasternal Subpectoral Plane Blocks for Cardiac Surgery Via a Midline Sternotomy
Sponsor:
Brigham and Women's Hospital
Organization:
Study Overview
Official Title:
Parasternal Subpectoral Plane Blocks for Patients Undergoing Cardiac Surgery Involving Median Sternotomy - a Study of Opioid and Pain Reduction
Status:
WITHDRAWN
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no support received
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To better determine whether parasternal subpectoral plane blocks (PSPB) infusing bupivacaine for midline sternotomy decreases opioid consumption and pain scores.
This is a prospective, blinded randomized controlled trial with 2 arms. 1 arm is the saline control arm, PSPB catheters will be placed with saline and continue to infuse saline. The other arm is bupivacaine study arm, PSPB catheters will be placed with bupivacaine and continue to infuse the local anesthetic.
This is a prospective, blinded randomized controlled trial with 2 arms. 1 arm is the saline control arm, PSPB catheters will be placed with saline and continue to infuse saline. The other arm is bupivacaine study arm, PSPB catheters will be placed with bupivacaine and continue to infuse the local anesthetic.
Detailed Description:
Subjects will be randomized to receive PSPB catheters infusing either bupivacaine or saline. Randomization will be achieved using a computer-generated randomization scheme. The surgeon, nurse, anesthetist and patient will be blinded. The investigational drug service will prepare blinded solutions (bupivacaine 0.2% or saline syringes) for performance of the block. They will also prepare bags (either bupivacaine 0.125% or saline) to be infused through the catheter.
Following skin closure, but before removal of the surgical drapes, regional anesthesiologists will scrub in, gown and perform the placement of PSPB catheters under strict surgical aseptic technique. Real-time ultrasound (US) imaging will be used to visualize the pectoralis major muscle and its corresponding rib cartilages, and a needle/introducer sheath will be guided parasternally into the fascial plane. The needle will be advanced in the plane, hydro-dissecting with 30 mL of bupivacaine 0.2% in the study group or 30 mL of saline in the control group per side. Following hydro-dissection, a 5 in. multiport catheter will be inserted via the sheath, and the catheter will be secured following US confirmation of appropriate catheter position. This procedure will then be repeated on the other side. After completion of bilateral PSPB catheters, patients will remain intubated and be transferred to the CSICU on a sedation regimen at the discretion of the intraoperative anesthesia team. Upon dropping off to the ICU, each catheter will be attached to a programmable pump infusing plain bupivacaine 0.125% at 10 mL/hr or saline infusing at 10 mL/hr. Once again, the solution to be infused postoperatively will be prepared by pharmacy and blinded from the patient, nurse, and postoperative pain service providers.
Following skin closure, but before removal of the surgical drapes, regional anesthesiologists will scrub in, gown and perform the placement of PSPB catheters under strict surgical aseptic technique. Real-time ultrasound (US) imaging will be used to visualize the pectoralis major muscle and its corresponding rib cartilages, and a needle/introducer sheath will be guided parasternally into the fascial plane. The needle will be advanced in the plane, hydro-dissecting with 30 mL of bupivacaine 0.2% in the study group or 30 mL of saline in the control group per side. Following hydro-dissection, a 5 in. multiport catheter will be inserted via the sheath, and the catheter will be secured following US confirmation of appropriate catheter position. This procedure will then be repeated on the other side. After completion of bilateral PSPB catheters, patients will remain intubated and be transferred to the CSICU on a sedation regimen at the discretion of the intraoperative anesthesia team. Upon dropping off to the ICU, each catheter will be attached to a programmable pump infusing plain bupivacaine 0.125% at 10 mL/hr or saline infusing at 10 mL/hr. Once again, the solution to be infused postoperatively will be prepared by pharmacy and blinded from the patient, nurse, and postoperative pain service providers.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: