Parasternal Subpectoral Plane Blocks for Cardiac Surgery Via a Midline Sternotomy
Primary Purpose
Pain, Postoperative
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Parasternal Subpectoral Plane Block
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bupivacaine
Saline
Arm Description
PSPB catheters will be placed with 60mL of 0.2% bupivacaine and continue to infuse bupivacaine 0.125% at 10mL/hr through the catheter
PSPB catheters will be placed with 60mL of saline and continue to infuse saline through the catheters.
Outcomes
Primary Outcome Measures
Opioid Consumption
Cumulative opioid consumption on post-operative day 1 and 2
Secondary Outcome Measures
Acute Postoperative Pain scores
At rest and activity, on a numerical rating scale (NRS) 0-10
Persistent Postoperative Pain scores
Persistent midline sternotomy pain, on a numerical rating scale (NRS) 0-10
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
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 to extubation
From arrival time to ICU to extubation
Length of ICU stay
When patients are deemed ready to be discharged from ICU
Length of hospital stay
When patients are deemed ready to be discharged from hospital
Incidence of delirium
Assessed using CAM-ICU
Time to first opioid administration after extubation
When patient first requests opioid after extubation
Full Information
NCT ID
NCT04788056
First Posted
February 26, 2021
Last Updated
March 4, 2021
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04788056
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Saline and Bupivacaine are both clear fluids and look identical. Research pharmacy will prepare blinded solutions for use in study.
Allocation
Randomized
Enrollment
154 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine
Arm Type
Experimental
Arm Description
PSPB catheters will be placed with 60mL of 0.2% bupivacaine and continue to infuse bupivacaine 0.125% at 10mL/hr through the catheter
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
PSPB catheters will be placed with 60mL of saline and continue to infuse saline through the catheters.
Intervention Type
Procedure
Intervention Name(s)
Parasternal Subpectoral Plane Block
Intervention Description
Nerve block catheter inserted into plane between rib cartilages and pectoralis muscle.
Primary Outcome Measure Information:
Title
Opioid Consumption
Description
Cumulative opioid consumption on post-operative day 1 and 2
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Acute Postoperative Pain scores
Description
At rest and activity, on a numerical rating scale (NRS) 0-10
Time Frame
through initial hospital stay, an average of 5 days
Title
Persistent Postoperative Pain scores
Description
Persistent midline sternotomy pain, on a numerical rating scale (NRS) 0-10
Time Frame
Measured at 1 year
Title
Pain and patient characteristics
Description
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
Title
Incidence of arrhythmia
Description
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
Title
Time to extubation
Description
From arrival time to ICU to extubation
Time Frame
Post-operative day 1
Title
Length of ICU stay
Description
When patients are deemed ready to be discharged from ICU
Time Frame
From arrival to ICU to discharge to floor, up to 5 days
Title
Length of hospital stay
Description
When patients are deemed ready to be discharged from hospital
Time Frame
From arrival to ICU to discharge from hospital, up to 5 days
Title
Incidence of delirium
Description
Assessed using CAM-ICU
Time Frame
Time in ICU to discharge to floor, up to 3 days
Title
Time to first opioid administration after extubation
Description
When patient first requests opioid after extubation
Time Frame
Extubation to first opioid administration, up to 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kamen Vlassakov, MD
Phone
6177328221
Email
kvlassakov@bwh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamen Vlassakov, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17006079
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.
Results Reference
background
PubMed Identifier
27343790
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.
Results Reference
background
PubMed Identifier
21283147
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. Erratum In: Nat Rev Rheumatol.. Correction on page following 224. Nat Rev Rheumatol. 2011 Jun;7(6):314. Calahan, Christine [corrected to Cahalan, Christine].
Results Reference
background
PubMed Identifier
16733157
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.
Results Reference
background
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Parasternal Subpectoral Plane Blocks for Cardiac Surgery Via a Midline Sternotomy
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