Study Summary
This trial is looking to see if a regional block helps with pain relief for those who have undergone heart surgery.
Eligible Conditions
- Post-operative Pain
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: Every 6 hours for 24 hours post-operatively
12 hours
Opioid consumption
2 weeks
ICU length of stay
24 hours
Local anesthetic systemic toxicity effects
Time to extubation
24 hours post-operatively
Opioid consumption in 24 hours
4 weeks
Surgical site infection rate
Hour 24
Pain score
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Intervention
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
156 Total Participants · 2 Treatment Groups
Primary Treatment: Pectointercostal fascia blocks · Has Placebo Group · Phase 4
Intervention
Procedure
Experimental Group · 1 Intervention: Pectointercostal fascia blocks · Intervention Types: ProcedurePlacebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: every 6 hours for 24 hours post-operatively
Who is running the clinical trial?
University of AlbertaLead Sponsor
816 Previous Clinical Trials
376,668 Total Patients Enrolled
Wing LamPrincipal InvestigatorUniversity of Alberta
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are expected to be fast track candidates post-operatively.
You are scheduled for cardiac bypass grafting and/or single valve surgery requiring cardiopulmonary bypass.
References
- Lloyd-Donald, Patryck, Wen-Shen Lee, James W. Hooper, Dong Kyu Lee, Alice Moore, Nikhil Chandra, Peter McCall, et al.. 2021. “Fast-track Recovery Program After Cardiac Surgery in a Teaching Hospital: A Quality Improvement Initiative”. BMC Research Notes. Springer Science and Business Media LLC. doi:10.1186/s13104-021-05620-w.
- Lee, Candice Y., Davida A. Robinson, Carl A. Johnson Jr., Yun Zhang, Joshua Wong, Devang J. Joshi, Tong-Tong Wu, and Peter A. Knight. 2019. “A Randomized Controlled Trial of Liposomal Bupivacaine Parasternal Intercostal Block for Sternotomy”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/j.athoracsur.2018.06.081.
- Nielsen, Suzanne, Louisa Degenhardt, Bianca Hoban, and Natasa Gisev. 2015. “A Synthesis of Oral Morphine Equivalents (OME) for Opioid Utilisation Studies”. Pharmacoepidemiology and Drug Safety. Wiley. doi:10.1002/pds.3945.
- Kar, Prachi, and Gopinath Ramachandran. 2020. “Pain Relief Following Sternotomy in Conventional Cardiac Surgery: A Review of Non Neuraxial Regional Nerve Blocks”. Annals of Cardiac Anaesthesia. Medknow. doi:10.4103/aca.aca_241_18.
- Nasr, DaliaAbdelhamid, HadeelMagdy Abdelhamid, Mai Mohsen, and AhmadHelmy Aly. 2015. “The Analgesic Efficacy of Continuous Presternal Bupivacaine Infusion Through a Single Catheter After Cardiac Surgery”. Annals of Cardiac Anaesthesia. Medknow. doi:10.4103/0971-9784.148314.
- Chin, K. J., B. Versyck, and A. Pawa. 2021. “Ultrasound‐guided Fascial Plane Blocks of the Chest Wall: A State‐of‐the‐art Review”. Anaesthesia. Wiley. doi:10.1111/anae.15276.
- McDonald, Susan B., Eric Jacobsohn, Dan J. Kopacz, Seema Desphande, James D. Helman, Francis Salinas, and R Alan Hall. 2005. “Parasternal Block and Local Anesthetic Infiltration with Levobupivacaine After Cardiac Surgery with Desflurane: The Effect on Postoperative Pain, Pulmonary Function, and Tracheal Extubation Times”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/01.ane.0000139652.84897.bd.
- de la Torre, P. A., P. D. Garcia, S. L. Alvarez, F. J. G. Miguel, and M. F. Perez. 2014. “A Novel Ultrasound-guided Block: A Promising Alternative for Breast Analgesia”. Aesthetic Surgery Journal. Oxford University Press (OUP). doi:10.1177/1090820x13515902.
- Fujii, Satoru, Ranjana Bairagi, Matthew Roche, and Jian Ray Zhou. 2019. “Transversus Thoracis Muscle Plane Block”. Biomed Research International. Hindawi Limited. doi:10.1155/2019/1716365.
- Kelava, Marta, Andrej Alfirevic, Sergio Bustamante, Jennifer Hargrave, and Donn Marciniak. 2020. “Regional Anesthesia in Cardiac Surgery: An Overview of Fascial Plane Chest Wall Blocks”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0000000000004682.
- Fujii S, Bairagi R, Roche M, Zhou JR. Transversus Thoracis Muscle Plane Block. Biomed Res Int. 2019 Jul 7;2019:1716365. doi: 10.1155/2019/1716365. eCollection 2019.
- Kar P, Ramachandran G. Pain relief following sternotomy in conventional cardiac surgery: A review of non neuraxial regional nerve blocks. Ann Card Anaesth. 2020 Apr-Jun;23(2):200-208. doi: 10.4103/aca.ACA_241_18.
- Chin KJ, Versyck B, Pawa A. Ultrasound-guided fascial plane blocks of the chest wall: a state-of-the-art review. Anaesthesia. 2021 Jan;76 Suppl 1:110-126. doi: 10.1111/anae.15276.
- de la Torre PA, Garcia PD, Alvarez SL, Miguel FJ, Perez MF. A novel ultrasound-guided block: a promising alternative for breast analgesia. Aesthet Surg J. 2014 Jan 1;34(1):198-200. doi: 10.1177/1090820X13515902. No abstract available.
- Kelava M, Alfirevic A, Bustamante S, Hargrave J, Marciniak D. Regional Anesthesia in Cardiac Surgery: An Overview of Fascial Plane Chest Wall Blocks. Anesth Analg. 2020 Jul;131(1):127-135. doi: 10.1213/ANE.0000000000004682.
- 2022. "Sternotomies and PectoIntercostal Fascia Blocks in Fast-Track Cardiac Anesthesiology". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05146453.
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