Parasternal Subpectoral Plane Blocks for Cardiac Surgery Via a Midline Sternotomy

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04788056
• Other study ID #: 2021P000486
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2021
• Est. completion date: June 2023

Study information

• Verified date: March 2021
• Source: Brigham and Women's Hospital
• Contact: Kamen Vlassakov, MD
• Phone: 6177328221
• Email: kvlassakov[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 154
• Est. completion date: June 2023
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• Parasternal Subpectoral Plane Block
Nerve block catheter inserted into plane between rib cartilages and pectoralis muscle.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

References & Publications (4)

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]. — View 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. Review. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Consumption	Cumulative opioid consumption on post-operative day 1 and 2	2 days
Secondary	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
Secondary	Persistent Postoperative Pain scores	Persistent midline sternotomy pain, on a numerical rating scale (NRS) 0-10	Measured at 1 year
Secondary	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
Secondary	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
Secondary	Time to extubation	From arrival time to ICU to extubation	Post-operative day 1
Secondary	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
Secondary	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
Secondary	Incidence of delirium	Assessed using CAM-ICU	Time in ICU to discharge to floor, up to 3 days
Secondary	Time to first opioid administration after extubation	When patient first requests opioid after extubation	Extubation to first opioid administration, up to 3 days