Parasternal Subpectoral Plane Blocks for Cardiac Surgery Via a Midline Sternotomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bupivacaine 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
Nerve block catheter inserted into plane between rib cartilages and pectoralis muscle.
|
| Placebo Comparator: Saline 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.
|
Outcome Measures
Primary Outcome Measures
- Opioid Consumption [2 days]
Cumulative opioid consumption on post-operative day 1 and 2
Secondary Outcome Measures
- Acute Postoperative Pain scores [through initial hospital stay, an average of 5 days]
At rest and activity, on a numerical rating scale (NRS) 0-10
- Persistent Postoperative Pain scores [Measured at 1 year]
Persistent midline sternotomy pain, on a numerical rating scale (NRS) 0-10
- Pain and patient characteristics [1 year]
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
- Incidence of arrhythmia [Hospital stay, an average of 5 days]
Whether active bupivacaine group has lower incidence of arrythmia versus saline control group. And whether this correlates to a certain plasma bupivacine level
- Time to extubation [Post-operative day 1]
From arrival time to ICU to extubation
- Length of ICU stay [From arrival to ICU to discharge to floor, up to 5 days]
When patients are deemed ready to be discharged from ICU
- Length of hospital stay [From arrival to ICU to discharge from hospital, up to 5 days]
When patients are deemed ready to be discharged from hospital
- Incidence of delirium [Time in ICU to discharge to floor, up to 3 days]
Assessed using CAM-ICU
- Time to first opioid administration after extubation [Extubation to first opioid administration, up to 3 days]
When patient first requests opioid after extubation
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or Female
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Aged 18 - 80 years
-
scheduled for primary elective cardiac surgery via median sternotomy
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willingness to undergo psychosocial testing
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willingness to participate in long-term follow up
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willingness to be randomized to receive local anesthetic or saline infusion through PSPB catheters
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access to an email and computer
Exclusion Criteria:
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Allergy to opioids
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allergy to bupivacaine
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emergency surgery
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unable to provide informed consent
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weight less than 50kg
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Brigham and Women's Hospital
Investigators
- Principal Investigator: Kamen Vlassakov, MD, Brigham and Women's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review. Erratum in: Nat Rev Rheumatol.. Correction on page following 224.. Nat Rev Rheumatol. 2011 Jun;7(6):314. Calahan, Christine [corrected to Cahalan, Christine].
- 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. Review.
- 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.
- Taillefer MC, Carrier M, Bélisle S, Levesque S, Lanctôt H, Boisvert AM, Choinière 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.
- 2021P000486