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Clinical Trials/NCT04788056
NCT04788056WithdrawnNot Applicable

Parasternal Subpectoral Plane Blocks for Patients Undergoing Cardiac Surgery Involving Median Sternotomy - a Study of Opioid and Pain Reduction

Brigham and Women's Hospital0 sites154 target enrollmentStarted: June 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Enrollment
154
Primary Endpoint
Opioid Consumption

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

Saline and Bupivacaine are both clear fluids and look identical. Research pharmacy will prepare blinded solutions for use in study.

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Male or Female
  • •Aged 18 - 80 years
  • •scheduled for primary elective cardiac surgery via median sternotomy
  • •willingness to undergo psychosocial testing
  • •willingness to participate in long-term follow up
  • •willingness to be randomized to receive local anesthetic or saline infusion through PSPB catheters
  • •access to an email and computer

Exclusion Criteria

  • •Allergy to opioids
  • •allergy to bupivacaine
  • •emergency surgery
  • •unable to provide informed consent
  • •weight less than 50kg

Arms & Interventions

Bupivacaine

Experimental

PSPB catheters will be placed with 60mL of 0.2% bupivacaine and continue to infuse bupivacaine 0.125% at 10mL/hr through the catheter

Intervention: Parasternal Subpectoral Plane Block (Procedure)

Saline

Placebo Comparator

PSPB catheters will be placed with 60mL of saline and continue to infuse saline through the catheters.

Intervention: Parasternal Subpectoral Plane Block (Procedure)

Outcomes

Primary Outcomes

Opioid Consumption

Time Frame: 2 days

Cumulative opioid consumption on post-operative day 1 and 2

Secondary Outcomes

  • Persistent Postoperative Pain scores(Measured at 1 year)
  • Incidence of arrhythmia(Hospital stay, an average of 5 days)
  • Length of ICU stay(From arrival to ICU to discharge to floor, up to 5 days)
  • Time to extubation(Post-operative day 1)
  • Acute Postoperative Pain scores(through initial hospital stay, an average of 5 days)
  • Pain and patient characteristics(1 year)
  • Length of hospital stay(From arrival to ICU to discharge from hospital, up to 5 days)
  • Incidence of delirium(Time in ICU to discharge to floor, up to 3 days)
  • Time to first opioid administration after extubation(Extubation to first opioid administration, up to 3 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kamen Vlassakov

Director of Regional Anesthesia

Brigham and Women's Hospital

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