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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Saline | Placebo Comparator | PSPB catheters will be placed with 60mL of saline and continue to infuse saline through the catheters. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parasternal Subpectoral Plane Block | Procedure | Nerve block catheter inserted into plane between rib cartilages and pectoralis muscle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | Cumulative opioid consumption on post-operative day 1 and 2 | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Postoperative Pain scores | At rest and activity, on a numerical rating scale (NRS) 0-10 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamen Vlassakov, MD | Brigham and Women's Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17006079 | Background | 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. | |
| 27343790 | Background | 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Saline and Bupivacaine are both clear fluids and look identical. Research pharmacy will prepare blinded solutions for use in study.
| 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 | 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 | Hospital stay, an average of 5 days |
| Time to extubation | From arrival time to ICU to extubation | Post-operative day 1 |
| Length of ICU stay | When patients are deemed ready to be discharged from ICU | 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 | From arrival to ICU to discharge from hospital, up to 5 days |
| Incidence of delirium | Assessed using CAM-ICU | 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 | Extubation to first opioid administration, up to 3 days |
| 21283147 | Background | 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. |
| 16733157 | Background | 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |