A Comparison of the Analgesic Effects of Pectointercostal Fascial Plane Block (PIFB) Alone Versus PIFB With Rectus Sheath Block (RSB) in Cardiac Surgery: a Prospective, Randomized Controlled Trial.
Phase: PHASE1
Conditions: Coronary Artery Disease, Postoperative Pain, Respiratory Failure
Sponsor: Medical College of Wisconsin

PRO00040365: A comparison of the analgesic effects of pectointercostal fascial plane block (PIFB) 
alone versus PIFB with rectus sheath block (RSB) in cardiac surgery: a prospective, randomized 
controlled trial. 
 
 
 
1 
1. Protocol Title 
A comparison of the analgesic effects of pectointercostal fascial plane block (PIFB) alone versus 
PIFB with rectus sheath block (RSB) in cardiac surgery: a prospective, randomized controlled 
trial. 
 
NCT04908449 
 
Updated 9.30.2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PRO00040365: A comparison of the analgesic effects of pectointercostal fascial plane block (PIFB) 
alone versus PIFB with rectus sheath block (RSB) in cardiac surgery: a prospective, randomized 
controlled trial. 
 
 
 
2 
2. Purpose of the study 
 
To determine if ultrasound-guided bilateral pectointercostal fascial plane blocks with bilateral rectus 
sheath blocks decrease pain scores, decrease opioid consumption, improve respiratory function, and 
improve quality of recovery in patients recovering from patients undergoing cardiac surgery in 
comparison to pectointercostal fascial plane blocks alone.   
 
 
4. Design and Procedures 
This is a single center, prospective, randomized, controlled, double-blinded study. We anticipate 
recruitment of 50-60 subjects (see #6 Recruitment and Compensation below), with 25-30 in each group. 
The definitive number will be determined by our final power analysis (see #12 Data analysis and 
statistical considerations below).  
 
Primary Outcome: 
Pain scores on a 0-10 numeric rating scale (NRS) at rest and with deep breathing at 1, 3, 6, 12, 18, and 24 
hours post-extubation between subjects receiving PIFB + RSB versus subjects receiving only PIFB.   
       
 
Secondary Outcomes: 
• 
Total cumulative opioid consumption at 24 and 48 hours post-operatively.  
• 
Change from baseline on incentive spirometry at 1, 3, 12, and 24 hours post-extubation  
• 
Time from ICU arrival to liberation from mechanical ventilation  
• 
ICU and hospital length of stay 
• 
QoR-15 (Quality of Recovery) score23 24 hours after extubation  
 
Preoperative Management  
Subjects will be randomized on the morning of surgery to receive bilateral PIFB and bilateral RSB with 
local anesthetic versus bilateral PIFB with local anesthetic and bilateral RSB with saline (placebo).  
 
Following the informed consent process, a member of the study team will instruct the patient on the 
appropriate use of incentive spirometry at the bedside and correct performance will be assessed. Three 
measurements will then be recorded to provide a baseline of incentive spirometry function.  
   
Intraoperative Management  
All subjects will receive the standard of care anesthetic regimen for their cardiac surgery, with specific 
medications at the discretion of their attending anesthesiologist, with the following exceptions: 
- 
Fentanyl and sufentanil will be the only narcotics used intraoperatively.  
- 
Fentanyl administration will be limited to bolus dosing, rather than infusions.  
- 
Any sufentanil infusions must be stopped prior to or upon arrival in the intensive 
care unit.  
- 
Sufentanil dosing range will be within 0.2-0.5 mcg/kg/hr. Extubation in the 
operating room is at the discretion of the attending anesthesiologist. 
- 
Furthermore, neuromuscular blockade will be reversed prior to handoff in the 
ICU.  
   
Postoperative Management  

PRO00040365: A comparison of the analgesic effects of pectointercostal fascial plane block (PIFB) 
alone versus PIFB with rectus sheath block (RSB) in cardiac surgery: a prospective, randomized 
controlled trial. 
 
 
 
3 
Each PIFB will be performed with 15 mL of 0.25% bupivacaine with 5 mcg/ml of epinephrine, 
and bilateral RSB will be performed with an additional 20 mL of 0.25% bupivacaine with 5 mcg/ml of 
epinephrine (10mL on each side).   
 
Single injection pectointercostal fascial plane blocks 
 
The ultrasound-guided pectointercostal fascial plane blocks will be performed as follows:20 a linear high 
frequency ultrasound probe will be placed in a parasagittal orientation between the third and fourth ribs, 
approximately one centimeter lateral to the sternal border, and all relevant structures will be identified, 
including the pectoralis major muscle, ribs, intercostal muscles, pleura, and any vasculature, including the 
internal mammary artery and vein. Color doppler will be used confirm the location of vasculature.  
 
After skin cleaning with sterile chlorhexidine solution, a 9 cm 21 gauge insulated block needle (Sonoplex, 
Pajunk Medical Systems, Norcross, GA) will be inserted in an in-plane approach. In this way, both the 
needle shaft and tip can be visualized as the needle approaches the plane between the internal intercostal 
and pectoralis major muscles. The needle will be redirected as needed. Once satisfactory position of the 
needle tip is confirmed and after frequent negative aspiration, 20 mL of a solution containing 0.25% 
bupivacaine with epinephrine 5 mcg/ml will be slowly injected with intermittent aspiration. Spread of 
local anesthetic will be documented in the appropriate plane in real time. This procedure will be 
performed bilaterally. 
 
All nerve blocks will be performed by an anesthesiologist experienced in regional anesthesia and/or a 
trainee supervised by an anesthesiologist experienced in regional anesthesia. 
 
Single injection bilateral high rectus sheath nerve blocks 
 
The ultrasound-guided rectus sheath blocks will be performed as described by Grant and Auyong21. A 
linear high frequency ultrasound probe will be placed in a transverse position in the midline, just inferior 
to the edge of the sternum. The probe will be moved laterally to visualize the lateral edge of the rectus 
abdominis muscle. The transversalis fascia, abdominal contents, and vasculature will be visualized, with 
color doppler confirmation of the location of vascular structures.  
 
After skin cleaning with sterile chlorhexidine, a 9 cm 21G insulated block needle (Sonoplex, Pajunk 
Medical Systems, Norcross, GA) will be inserted from the lateral aspect of the ultrasound probe in a 
lateral to medial direction and aligned with the ultrasound scanning plane (in-plane approach). In this 
way, both the needle shaft and tip can be visualized as the needle approaches the rectus sheath plane, just 
deep to rectus abdominis and superficial to the posterior fascia. The needle will be redirected as needed. 
Once satisfactory position of the needle time is confirmed and after frequent negative aspiration, 10 mL 
of a solution containing 0.25% bupivacaine with epinephrine 5 mcg/ml or saline will be slowly injected 
with intermittent aspiration into this plane. Spread of local anesthetic will be documented in the 
appropriate plane in real time. This procedure will be repeated on the contralateral side. 
 
Again, all nerve blocks will be performed by an anesthesiologist experienced in regional anesthesia 
and/or a trainee supervised by an anesthesiologist experienced in regional anesthesia. 
 
Postoperative Evaluation 
Evaluation of acute postoperative pain intensity using a 0-10 numeric rating scale (NRS) will be 
undertaken at the following time points, both at rest and with deep breathing:  

PRO00040365: A comparison of the analgesic effects of pectointercostal fascial plane block (PIFB) 
alone versus PIFB with rectus sheath block (RSB) in cardiac surgery: a prospective, randomized 
controlled trial. 
 
 
 
4 
• 
1, 3, 6, 12, 18, and 24 hours post-extubation  
Incentive spirometry will be assessed at 1, 3, 12, and 24 hours post-extubation, with three measures taken 
at each time point in order to compare postoperative performance with baseline spirometry.  
Review of the medical chart will be made post-operatively to gather other data, including total 
intraoperative oral morphine equivalent consumption, cumulative opioid consumption at 24 and 48 hours, 
time from ICU arrival to tracheal extubation, length of stay in the ICU, length of stay in the hospital, 
administration of other analgesic or sedating medications in the first 48 hours after extubation, and QoR-
15 (Quality of Recovery) score22 administered 24 hours after extubation (with margin of error of 18-30 
hours to avoid waking patients in the middle of the night). Occurrences of any adverse events reported by 
the subject or medical team will also be collected.   
 
Collect additional surgical data: intraoperative OME, total surgical time, total cardiopulmonary bypass 
time, and total aortic crossclamp time. It is important to collect this data in order to control for these 
elements, as it is known that longer cardiopulmonary bypass time and aortic crossclamp time are 
associated with longer time to extubation and longer ICU length of stay 23. 
 
5. Selection of subjects 
Criteria for inclusion:  
• 
Subjects scheduled for elective cardiac surgery involving primary median sternotomy and 
subxiphoid chest tube placement  
• 
Age 18-85 years of age  
• 
BMI 18-50 kg/m2  
• 
Weight > 60 kg  
 
Criteria for exclusion: 
• 
Left ventricular ejection fraction (LVEF) < 30%  
• 
Preoperative, intraoperative, or immediate post-operative placement of intra-aortic 
balloon pump or deployment of extra-corporeal membrane oxygenation (ECMO)  
• 
Inability to understand or speak English  
• 
Allergy to bupivacaine or other amide local anesthetic  
• 
Contraindication to peripheral nerve block (e.g. local infection, previous trauma to the 
block site)  
• 
Chronic opioid consumption (daily oral morphine equivalent of >20 mg) in the past three 
months  
• 
Severe pulmonary or hepatic disease  
• 
Neurological deficit or disorder  
• 
Suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or 
alcohol within the past two years  
• 
Uncontrolled anxiety, schizophrenia, or other severe psychiatric disorder  
• 
Patients who remain intubated for >24 hours after the stop of anesthesia will be removed 
from the study 
 
6. Subject recruitment and compensation 
Participating cardiac surgeons will share a basic study information sheet with potential subjects in their 
pre-operative surgery clinic visit. Potential subjects (see inclusion criteria above) will be identified on the 
surgical schedule by a member of the study team, typically at least one day in advance of the surgical 
procedure. These individuals will be contacted by telephone or in-person, if they are pre-admitted, and 
asked for permission to discuss the study. The purpose of the study will be explained, the consent form 

PRO00040365: A comparison of the analgesic effects of pectointercostal fascial plane block (PIFB) 
alone versus PIFB with rectus sheath block (RSB) in cardiac surgery: a prospective, randomized 
controlled trial. 
 
 
 
5 
read out loud, and any questions answered. Potential subjects will be encouraged to take time to discuss 
the study with family and will be told that there will be additional time to answer any questions on the 
day of surgery (or date prior, if pre-admitted). Potential subjects will be told that there is no obligation to 
take part in the study and their decision will not affect the quality of their care.   
 
On the day of surgery or day prior to surgery (if pre-admitted), one of the investigators will approach the 
potential subject in his/her hospital room or the preoperative area, as appropriate, and answer any 
remaining questions. Subjects that indicate their interest in participating will then sign an informed 
consent and complete a HIPAA authorization form. There will be no compensation for subjects for their 
participation.   
   
 
7. Consent process 
The consent process will be conducted by one of the study team members. The consent process will take 
place in the patient’s hospital room or the pre-operative area, depending on whether or not the patient has 
been pre-admitted. Throughout the consent process, measures will be taken to maintain privacy, such as 
conducting face-to-face conversations in private rooms. As much time as necessary will be spent with 
each potential subject to sufficiently explain and answer all questions and address all concerns they may 
have in regard to the study and/or consent process. 
 
 
8. 
Subject’s Capacity to Give Legally Effective Consent 
Subjects who do not have the capacity to give legal consent will not be approached for participation in 
this study. 
 
9. Study interventions 
See #4. 
 
10. Risk/benefit assessment 
Risk to the subject 
This study involves multiple injections, either with a local anesthetic solution or saline. Risks associated 
with the nerve block include bleeding, infection, nerve damage, and damage to surrounding structures, 
including blood vessels and lungs. 
 
Benefits to the subject 
The potential benefit of participating in the study is that patients receiving PIFB + RSB may require less 
pain medication resulting in fewer side effects, experience improved respiratory function, and achieve 
milestones sooner than those who do not receive PIFB + RSB blocks. 
 
11. Costs 
There will be no costs to the subject for participation in the study. Subjects will not be compensated for 
their participation. 
 
12. Data analysis and statistical considerations 
  
In order to appropriately complete our power analysis, following IRB approval and prior to patient 
recruitment we will review charts of 10-20 patients who have undergone CABG surgery and who have 

PRO00040365: A comparison of the analgesic effects of pectointercostal fascial plane block (PIFB) 
alone versus PIFB with rectus sheath block (RSB) in cardiac surgery: a prospective, randomized 
controlled trial. 
 
 
 
6 
received PIFBs within the last year at our institution in order to define baseline pain scores within the first 
24 hours and opioid usage within the first 48 hours postoperatively.   
 
Our data analysis plan is as as follows: since we had no pilot data on AUC pain outcomes, we considered 
a conservative scenario when the two outcomes are uncorrelated and described detectible 
differences between study outcomes in terms of standard deviations (SDs). To evaluate power properties 
of the Hotelling T2 at ALPHA = 5% test, we considered statistical power of two two-sample t-tests at 
ALPHA = 2.5%. At 24 patients per group, the detectible at 80% power difference between group means = 
0.9 SDs (ALPHA = 2.5%). If the normality assumption is violated, Mann-Whitney test will have the same 
power properties at 25 patients per group. At 29 patients per group, the detectible at 80% power 
difference between group means = 0.8 SDs (ALPHA = 2.5%); Mann-Whitney nonparametric alternative 
will have the same power properties at 30 patients per group.  
  
  
13. Data & Safety Monitoring 
In accordance with federal regulations the PI will monitor for, review, and promptly report to the IRB, 
appropriate institutional officials, sponsor, coordinating center and the appropriate regulatory agency head 
all unanticipated problems involving risks to subjects or others that occur in the course of a subject’s 
participation in a research study, all AE reports will be reported per the MCW IRB policies. PI will be 
monitoring all AEs and submitting reports to the IRB per MCW IRB policy. 
 
Furthermore, an independent monitor has been chosen for the study, and this individual is a regional 
anesthesiologist, who will not be involved in study proceedings but who will be updated on study 
progress as per the DSMP. 
 
14. 
Privacy, Data Storage and Confidentiality 
 
Potential subjects and their families will be approached in private rooms or preoperative bays. Any guests 
not involved in the consent process will be asked to leave the room during any communications, unless 
the subject allows them to be present. Efforts to maintain subject confidentiality will include assignment 
of following Federal Privacy Regulations which provide safeguards for privacy, security, and authorized 
access. Except when required by law, subjects will not be identified by name, social security number, 
address, telephone number, or any other direct personal identifier in study records disclosed outside of 
Medical College of Wisconsin or Froedtert Hospital.  Subjects will be not be revealed in any reports or 
publications resulting from this study.  For records disclosed outside of MCW/Froedtert, subjects will be 
assigned a unique code number. The paper/electronic data will be stored as per the data safety and 
monitoring plan. 
 
The only exception to the above is that the Investigational Drug Services pharmacy may unblind in cases 
of medical emergency with written or verbal consent from Dr. Castro (PI). Only the investigator will be 
unblinded to the subject's treatment group, and this will be done only in the case of a medical emergency. 
 
References 
 
1. Lahtinen, P., Kokki, H. & Hynynen, M. Pain after cardiac surgery: a prospective cohort study of 1-year 
incidence and intensity. Anesthesiology 105, 794-800, doi:10.1097/00000542-200610000-00026 (2006). 
2. . Lee, C. Y. et al. A Randomized Controlled Trial of Liposomal Bupivacaine Parasternal Intercostal Block for 
Sternotomy. Ann Thorac Surg 107, 128-134, doi:10.1016/j.athoracsur.2018.06.081 (2019). 

PRO00040365: A comparison of the analgesic effects of pectointercostal fascial plane block (PIFB) 
alone versus PIFB with rectus sheath block (RSB) in cardiac surgery: a prospective, randomized 
controlled trial. 
 
 
 
7 
3. Janssen-Sanders Ll, G. L., Bruins P, Driessen A, Morshuis W, Knibbe C, Dongen EV. Pain in intensive care 
after sternotomy is predictive for chronic thoracic pain. Critical Care 12, P510, doi:10.1186/cc6731 
(2008). 
4. Dogan Baki, E. et al. Effects of Parasternal Block on Acute and Chronic Pain in Patients Undergoing Coronary 
Artery Surgery. Semin Cardiothorac Vasc Anesth 20, 205-212, doi:10.1177/1089253215576756 (2016). 
5. Costa, M. A. et al. Factors Associated With the Development of Chronic Post-Sternotomy Pain: a Case-Control 
Study. Braz J Cardiovasc Surg 30, 552-556, doi:10.5935/1678-9741.20150059 (2015). 
6. McDonald S, J. E., Kopacz D, Desphande S, Helman J, Salinas F, Hall R. 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 and Analgesia 100, 
25-32, doi:10.1213/01.ANE.0000139652.84897.BD (2005). 
7. Fujii, S. et al. Transversus thoracis muscle plane block in cardiac surgery: a pilot feasibility study. Reg Anesth 
Pain Med 44, 556-560, doi:10.1136/rapm-2018-100178 (2019). 
8. Ozturk, N. K. et al. Comparison of Transcutaneous Electrical Nerve Stimulation and Parasternal Block for 
Postoperative Pain Management after Cardiac Surgery. Pain Res Manag 2016, 4261949, 
doi:10.1155/2016/4261949 (2016). 
9. Mueller XM, Tinguely F, Tevaearai HT, Ravussin P, Stumpe F, von Segesser LK. Impact of duration of chest 
tube drainage on pain after cardiac surgery. Eur J Cardiothorac Surg. 2000 Nov;18(5):570-4. doi: 
10.1016/s1010-7940(00)00515-7. PMID: 11053819. 
 
10. Engelman D, B. A. W., Williams J, Perrault L, Reddy V, Arora R, Roselli E, Khoynezhad A, Gerdisch M, 
Levy J, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman R, Gregory A, Boyle E. Guidelines for 
Perioperative Care in Cardiac Surgery Enhanced Recovery After Surgery Society Recommendations. 
JAMA Surgery 154, 755-766, doi:10.1001/jamasurg.2019.1153 (2019). 
11. Liu, V., Mariano, E. R. & Prabhakar, C. Pecto-intercostal Fascial Block for Acute Poststernotomy Pain: A 
Case Report. A A Pract 10, 319-322, doi:10.1213/XAA.0000000000000697 (2018). 
12. de la Torre PA, García PD, Alvarez SL, Miguel FJ, Pérez 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. PMID: 24396082. 
13. Jones, J., Murin, P. J. & Tsui, J. H. Opioid free postoperatively using Pecto-Intercostal Fascial Block (PIFB) 
with multimodal Analgesia (MMA) in a patient with myasthenia gravis underwent thymectomy via 
sternotomy. J Clin Anesth 59, 32-33, doi:10.1016/j.jclinane.2019.06.009 (2019). 
14. Fujii S, B. R., Roche M, Zhou J. Transversus Thoracis Muscle Plane Block. BioMed Research International 
2019, doi:10.1155/2019/1716365 (2019). 
15. Khera T, Murugappan K, Leibowitz A, Bareli N, Shankar P, Gilleland A, Wilson K, Oren-Grinberg A, 
Novack V, Venkatachalam S, Rangasamy V, Subramaniam B. Ultrasound-Guided Pecto-Intercostal 
Fascial Block for Postoperative Pain Management in Cardiac Surgery: A Prospective, Randomized, 
Placebo-Controlled Trial. Journal of Cardiothoracic and Vascular Anesthesia 2021. 35(3):896-903 
16. Sepolvere G, Tedesco M, Fusco P, Scimia P, Donatiello V, Cristiano L. Subxiphoid cardiac drainage pain 
management: could ultrasound rectus sheath block be the answer? Minerva Anestesiol. 2020 
Sep;86(9):994-996. doi: 10.23736/S0375-9393.20.14576-0. Epub 2020 May 18. PMID: 32420716. 
17. Einhorn LM, Andrew BY, Nelsen DA, Ames WA. Analgesic Effects of a Novel Combination of Regional 
Anesthesia After Pediatric Cardiac Surgery: A Retrospective Cohort Study. J Cardiothorac Vasc Anesth. 
2022 Nov;36(11):4054-4061. doi: 10.1053/j.jvca.2022.07.014. Epub 2022 Jul 14. PMID: 35995635. 
18. Yamamoto T, Seino Y, Matsuda K, Imai H, Bamba K, Sugimoto A, Shiraishi S, Schindler E. Preoperative 
Implementation of Transverse Thoracic Muscle Plane Block and Rectus Sheath Block Combination for 
Pediatric Cardiac Surgery. J Cardiothorac Vasc Anesth.  
2020 Dec;34(12):3367-3372. doi: 10.1053/j.jvca.2020.07.041. Epub 2020 Jul 16. PMID: 32800620\ 

PRO00040365: A comparison of the analgesic effects of pectointercostal fascial plane block (PIFB) 
alone versus PIFB with rectus sheath block (RSB) in cardiac surgery: a prospective, randomized 
controlled trial. 
 
 
 
8 
19. Everett L, Davis TA, Deshpande SP, Mondal S. Implementation of Bilateral Rectus Sheath Blocks in 
Conjunction With Transversus Thoracis Plane and Pectointercostal Fascial Blocks for Immediate 
Postoperative Analgesia After Cardiac Surgery. Cureus. 2022 Jul 5;14(7):e26592. doi: 
10.7759/cureus.26592. PMID: 35936156; PMCID: PMC9354918. 
20. George R, Dahl K, de Haan J. How I do it: Transversus Thoracic Plane and Pecto-intercostal Fascial Block. 
November 2019 issue of ASRA News. https://www.asra.com/asra-news/article/250/how-i-do-it-
transversus-thoracic-plane-a#r12  
21. Grant S, A. D. Ultrasound Guided Regional Anesthesia. Second edn,  (Oxford University Press, 2017). 
22. Kleif J, Waage J, Christensen KB, Gögenur I. Systematic review of the QoR-15 score, a patient- reported 
outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 
Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22. PMID: 29397134.  
23. (Totonchi Z, Azarfarin R, Jafari L, Alizadeh Ghavidel A, Baharestani B, Alizadehasl A, Mohammadi Alasti F, 
Ghaffarinejad MH. Feasibility of On-table Extubation After Cardiac Surgery with Cardiopulmonary 
Bypass: A Randomized Clinical Trial. Anesth Pain Med. 2018 Sep 24;8(5):e80158. doi: 
10.5812/aapm.80158. PMID: 30533392; PMCID: PMC6240920.).