Clinical trial NCT04788056: Parasternal Subpectoral Plane Blocks for Cardiac Surgery Via a Midline Sternotomy
Official title: Parasternal Subpectoral Plane Blocks for Patients Undergoing Cardiac Surgery Involving Median Sternotomy - a Study of Opioid and Pain Reduction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Allergy to opioids
2. allergy to bupivacaine
3. emergency surgery
4. unable to provide informed consent
5. weight less than 50kg

Primary outcomes:
measure: Opioid Consumption
timeFrame: 2 days
Secondary outcomes:
measure: Acute Postoperative Pain scores
timeFrame: through initial hospital stay, an average of 5 days
measure: Persistent Postoperative Pain scores
timeFrame: Measured at 1 year
measure: Pain and patient characteristics
timeFrame: 1 year
measure: Incidence of arrhythmia
timeFrame: Hospital stay, an average of 5 days
measure: Time to extubation
timeFrame: Post-operative day 1
measure: Length of ICU stay
timeFrame: From arrival to ICU to discharge to floor, up to 5 days
measure: Length of hospital stay
timeFrame: From arrival to ICU to discharge from hospital, up to 5 days
measure: Incidence of delirium
timeFrame: Time in ICU to discharge to floor, up to 3 days
measure: Time to first opioid administration after extubation
timeFrame: Extubation to first opioid administration, up to 3 days
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Kamen Vlassakov, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lahtinen P, Kokki H, Hynynen M. Pain after cardiac surgery: a prospective cohort study of 1-year incidence and intensity. Anesthesiology. 2006 Oct;105(4):794-800. doi: 10.1097/00000542-200610000-00026.
citation: Huang AP, Sakata RK. Pain after sternotomy - review. Braz J Anesthesiol. 2016 Jul-Aug;66(4):395-401. doi: 10.1016/j.bjane.2014.09.013. Epub 2016 Apr 23.
citation: Edwards RR, Cahalan C, Mensing G, Smith M, Haythornthwaite JA. Pain, catastrophizing, and depression in the rheumatic diseases. Nat Rev Rheumatol. 2011 Apr;7(4):216-24. doi: 10.1038/nrrheum.2011.2. Epub 2011 Feb 1.
citation: Taillefer MC, Carrier M, Belisle S, Levesque S, Lanctot H, Boisvert AM, Choiniere M. Prevalence, characteristics, and predictors of chronic nonanginal postoperative pain after a cardiac operation: a cross-sectional study. J Thorac Cardiovasc Surg. 2006 Jun;131(6):1274-80. doi: 10.1016/j.jtcvs.2006.02.001.