An interventional study of Parasternal Subpectoral Plane Block in Pain, Postoperative, sponsored by Brigham and Women's Hospital. Withdrawn. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
PSPB catheters will be placed with 60mL of 0.2% bupivacaine and continue to infuse bupivacaine 0.125% at 10mL/hr through the catheter
Procedure: Parasternal Subpectoral Plane Block
PSPB catheters will be placed with 60mL of saline and continue to infuse saline through the catheters.
Procedure: Parasternal Subpectoral Plane Block
Nerve block catheter inserted into plane between rib cartilages and pectoralis muscle.
Opioid Consumption
Cumulative opioid consumption on post-operative day 1 and 2
Time frame: 2 days
Acute Postoperative Pain scores
At rest and activity, on a numerical rating scale (NRS) 0-10
Time frame: through initial hospital stay, an average of 5 days
Persistent Postoperative Pain scores
Persistent midline sternotomy pain, on a numerical rating scale (NRS) 0-10
Time frame: Measured at 1 year
Pain and patient characteristics
Whether there is a correlation between development of persistent post-sternotomy pain and psychosocial/psychophysical characteristics. Will be ascertained from a variety of questionnaires (i.e. brief pain index, brief symptom inventory, coping strategies, fibromyalgianess, pain catastrophizing scale, positive and negative affect scale, PROMIS anxiety short form (SF), PROMIS depression SF, PROMIS sleep disturbance SF
Time frame: 1 year
Incidence of arrhythmia
Whether active bupivacaine group has lower incidence of arrythmia versus saline control group. And whether this correlates to a certain plasma bupivacine level
Time frame: Hospital stay, an average of 5 days
Time to extubation
From arrival time to ICU to extubation
Time frame: Post-operative day 1
Length of ICU stay
When patients are deemed ready to be discharged from ICU
Time frame: From arrival to ICU to discharge to floor, up to 5 days
Length of hospital stay
When patients are deemed ready to be discharged from hospital
Time frame: From arrival to ICU to discharge from hospital, up to 5 days
Incidence of delirium
Assessed using CAM-ICU
Time frame: Time in ICU to discharge to floor, up to 3 days
Time to first opioid administration after extubation
When patient first requests opioid after extubation
Time frame: Extubation to first opioid administration, up to 3 days
No study locations are listed for this record.
Plan to share: No
This study is withdrawn, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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