Cardiac SurgeryPhase 2/3NCT05054179
Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain
A Phase 2/3 study testing Ropivacaine 0.2% Injectable Solution Bolus, Normal Saline Infusion and Ropivacaine 0.2% Injectable Solution Infusion in people with Cardiac Surgery and Sternotomy, run by University of British Columbia at 1 site in Canada.
Trial summary
One of the most painful aspects of open heart surgery is the incision made through the skin and the sternum to access the heart (a "sternotomy"). Post-sternotomy pain is a potentially debilitating complication of surgery that slows recovery immediately after surgery and can lead to issues with chronic pain. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiac Surgery, Sternotomy, Acute Pain
- What is being tested?
- Ropivacaine 0.2% Injectable Solution Bolus, Normal Saline Infusion and Ropivacaine 0.2% Injectable Solution Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 7 Sep 2022to Jul 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled cardiac surgery patients
- Complete median sternotomy
- Adult (19 years old or older)
- English-speaking
Who cannot join
- Preoperative Exclusion Criteria:
- Patient refusal
- Emergent surgery
- Inability to provide consent
- Expected inability to follow up via telephone
- Known preoperative coagulopathy
Show all 23Show fewer
- Congenital coagulopathy ii) Congenital platelet disorders iii) Platelet count < 50 x 10^9 iv) International normalized ratio (INR) or activated partial thromboplastin time (aPTT) exceeding the upper range of normal in the absence of anticoagulant use v) Does not include active anticoagulant or antiplatelet use
- Known predicted post-operative therapeutic anticoagulation within 48 hours.
- Known skin disease over block insertion site that would prevent catheter securement
- Known Immunodeficiency including uncontrolled diabetes, as defined by HbA1C of 7.8% or more
- Known preoperative advanced liver failure (as defined by Child-Pugh B or C)
- Known preoperative advanced renal failure (as defined by Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m2)
- Known opioid tolerance (as defined by morphine oral equivalent >60mg for a period of 7 days or longer pre-operatively)
- Known allergy to local anesthetic, acetaminophen, or hydromorphone
- Known weight less than 60 kg
- Any known technical or physical barrier to block catheter placement (i.e., deep brain stimulation pulse generator or other devices, breast or other implants)
- Postoperative Exclusion Criteria:
- Postoperative bleeding at time of randomization as defined by:
- initial chest tube loss of >350 mL ii) >200 mL per hour loss iii) > 2 mL/kg/hour loss for 2 consecutive hours iv) or requiring return to the operating room for surgical management
- Hemodynamic instability, as determined by Cardiac Surgery Intensive Care Unit (CSICU) attending anesthesiologist
- Anticipated mechanical ventilation of more than 24 hours
- Anesthesiologist unavailable to insert Pecto-Intercostal Fascial Plane Block (PIFB) catheter within 4 hours of CSICU arrival
- Any known technical or physical barrier to block catheter placement (i.e., deep brain stimulation pulse generator or other devices, breast or other implants)
Trial locations and contacts
1 site in 1 country.
Tim TH Jen, MD contact
Canada1 site, 1 recruiting
- Recruiting
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Nicola Edwards, MHA, 778-870-5520, nedwards@providencehealth.bc.ca
About this study
Official title: The Efficacy of Pecto-intercostal Fascial Plane Catheters for Reduction of Sternal Pain in Cardiac Surgery Patients With Complete Median Sternotomy: A Randomized, Placebo-controlled Trial
One of the most painful aspects of open heart surgery is the incision made through the skin and the sternum to access the heart (a "sternotomy"). Post-sternotomy pain is a potentially debilitating complication of surgery that slows recovery immediately after surgery and can lead to issues with chronic pain. Previous research has shown that by injecting local anesthesia in the pecto inter-fascial plane, the space between the pectoralis major and the intercostal muscles, pain relief can be provided. The investigators aim to assess if repeated injections of local anesthesia via catheters is a useful adjunct compared to routine care.
Read the detailed description
Justification:
Post-sternotomy pain after cardiac surgery can be debilitating, with associated risks of decreased respiratory function and chronic pain. Severe acute sternal pain after cardiac surgery occurs in 49% of patients at rest and 78% of patients during coughing. Post-sternotomy pain is worst during the first two days and improves thereafter.
The sternum is innervated by the medial division of the anterior cutaneous branches of the T2-6 intercostal nerves, which may be targeted by several regional anesthetic techniques. Concerns of rare epidural hematoma and possible case cancellations with a bloody tap, in the context of systemic heparinization for cardiac surgery, deters many from utilizing neuraxial analgesia for post-sternotomy pain. Contrarily, parasternal regional blocks such as pecto-intercostal fascial plane block (PIFB) provide a low-risk alternative that targets the anterior cutaneous branches of intercostal nerves, and PIFB has been shown to be effective in improving acute post-sternotomy pain.
Nevertheless, single-shot PIFB is limited by its short duration of action, whereas sternotomy pain can remain severe for two postoperative days. Hence, continuous local anesthetic infusion via bilateral PIFB catheters for 48 hours may improve patient pain experience and related outcomes over single shot PIFB.
Objective:
This study aims to evaluate whether, in addition to single shot PIFB, continuous local anesthetic infusion (compared with placebo infusion) through bilateral PIFB catheters reduces acute sternal pain at 24 hours after cardiac surgery with complete median sternotomy. The 24-hour time point was chosen as it represents a time where both the post-sternotomy pain is rated as severe, especially with movement and coughing, and the patient is required to start actively participating in the postoperative rehabilitative process.
Hypotheses:
This study hypothesize that, in addition to single shot PIFB, continuous ropivacaine infusion through bilateral PIFB catheters will be more effective than placebo infusion in reducing sternal pain score on standardized coughing at 24 hours after cardiac surgery with complete median sternotomy.
Study Design:
This will be a prospective, randomized, triple-blinded, placebo-controlled trial in which patients will be randomly allocated to two study groups on a 1:1 basis into:
- Treatment Group: 20 mL of ropivacaine 0.2% will be deposited via parasternal multi-orifice catheters on each side, followed by infusion of 3 mL/h for 48 hours.
- Control Group: 20 mL of ropivacaine 0.2% will be deposited via parasternal multi-orifice catheters on each side, followed by a saline infusion of 3 mL/h for 48 hours.
- Conditions
- Cardiac Surgery, Sternotomy, Acute Pain
- Being tested
- Ropivacaine 0.2% Injectable Solution Bolus, Normal Saline Infusion, Ropivacaine 0.2% Injectable Solution Infusion
- Keywords
- Pecto-intercostal fascial plane catheters, Cardiac surgery, Heart surgery, Sternotomy, Acute pain, Post-sternotomy pain, Chronic Pain
- Medical subject headings
- Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.2% Injectable Solution BolusDrug
20 mL of ropivacaine 0.2% will be injected via parasternal multi-orifice catheters on each side
Normal Saline InfusionOther
3 mL/hour infusion of normal saline for 48 hours via parasternal multi-orifice catheters on each side of the sternum
Ropivacaine 0.2% Injectable Solution InfusionDrug
3 mL/h infusion of Ropivacaine 0.2% for 48 hours via parasternal multi-orifice catheters on each side of the sternum
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The participants of this group will receive 20 mL of 0.2% Ropivacaine via parasternal multi-orifice catheters on each side of the sternum, followed by infusion of 3 mL/h for 48 hours. Receives: Drug: Ropivacaine 0.2% Injectable Solution Bolus; Drug: Ropivacaine 0.2% Injectable Solution Infusion |
| Placebo group | Placebo comparator | The participants of this group will receive 20 mL of 0.2% Ropivacaine via parasternal multi-orifice catheters on each side of the sternum, followed by infusion of 3 mL/h of normal saline for 48 hours. Receives: Drug: Ropivacaine 0.2% Injectable Solution Bolus; Other: Normal Saline Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Sternal Pain on coughing at 24 hours.
Cardiac Surgery Intensive Care Unit nurses or recovery ward nurses will assess and record Numeric Rating Scale (NRS) sternal pain scores on coughing. Coughing will be elicited with a standardized script for a sitting patient:
"Please use both hands to hold on to the pillow in front of you to hold your chest in. Take a deep breath in, and give me three coughs in a row"
The scale is from 0 to 10, with 0 being no pain at all and 10 being the worst pain possible.
Measured: Post-surgery 24 hours after intervention
Secondary outcomes (7)
Cumulative opioid consumption (in IV morphine equivalents)
After patient's discharge from hospital, medical record will be reviewed for opioid (in IV morphine equivalents) consumption history.
Measured: Post-surgery at 24 and 48 hours after intervention
Post-operative sternal pain severity
Cardiac Surgery Intensive Care Unit nurses or recovery ward nurses will assess and record Numeric Rating Scale (NRS) sternal pain scores at rest and on coughing up to 48 hours after the intervention.
Coughing will be elicited with a standardized script for a sitting patient:
"Please use both hands to hold on to the pillow in front of you to hold your chest in. Take a deep breath in, and give me three coughs in a row".
The scale is from 0 to 10, with 0 being no pain at all and 10 being the worst pain possible.
These scores will be recorded every 8 hours.
Measured: Post surgery, every 8 hours after intervention up to 48 hours
Nausea or vomiting
After patient's discharge from hospital, medical record will be reviewed for nausea or vomiting and reported as yes or no.
Measured: Post-surgery within 48 hours of intervention
Quality of Recovery-15 score (QoR-15)
The research assistant/research coordinator will administer Quality of Recovery-15 score (QoR-15). The QoR-15 includes Part A and Part B. Part A consists of 10 questions regarding how the patient has been feeling in the last 24 hours on a 11-point likert scale from 0 to 10, with 0 being "None of the time" and 10 being "All of the time". Part B consists of 5 questions regarding if the patient has had any of the following in the last 24 hours on the same scale as Part A.
Measured: Pre-surgery (at enrolment) and Post-surgery at 48 hours
Chronic sternal pain
After patient's discharge from hospital, they will be called at 3 months and 6 months post-surgery and asked about their sternal pain severity on a numeric rating scale of 0-10.
Measured: Post-surgery at 3 months and 6 months
Quality of Life Questionnaire
Participants will complete a quality of life questionnaire, the EQ-5D-5L, preoperatively, at 48 hours, 3 months and 6 months. The first two assessments will be done in person, the 3 and 6 month follow-ups will be done over the phone. The questionnaire consists of 5 dimensions of life (Mobility, Self-Care, Usual Activities, Pain and Discomfort, and Anxiety/Depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: Pre-operatively (at enrolment), 48 hours after intervention and 3 and 6 months after discharge from hospital
Overall Health (EQ-5D VAS)
Participants will report their overall health rating using the EQ-5D Visual Analog Scale (0-100, with 0 being the worst health you can imagine and 100 being the best health you can imagine). This is done preoperatively, at 48 hours, 3 months and 6 months. The first two assessments will be done in person, the 3 and 6 month follow-ups will be done over the phone.
Measured: Pre-operatively (at enrolment), 48 hours after intervention and 3 and 6 months after discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start7 Sep 2022
- Primary completionJan 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a prospective, randomized, triple-blinded, placebo-controlled trial in which patients will be randomly allocated to two study groups on a 1:1 basis into: 1\) Intervention Group: 20 mL of ropivacaine 0.2% will be bolused through PIFB catheters on each side, followed by 3 mL/hour infusion of ropivacaine 0.2% for 48 hours each side. 2\) Control Group: 20 mL of ropivacaine 0.2% will be bolused through PIFB catheters on each side, followed by 3 mL/hour infusion of normal saline for 48 hours each side.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ron Ree, University of British Columbia
- Investigators
- Ron Ree, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054179
- Sponsor's protocol ID
- PIFB Catheter RCT
- Status last verified
- Nov 2022
- First submitted
- 19 Aug 2021
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers.
Publications
Liu V, Mariano ER, Prabhakar C. Pecto-intercostal Fascial Block for Acute Poststernotomy Pain: A Case Report. A A Pract. 2018 Jun 15;10(12):319-322. doi: 10.1213/XAA.0000000000000697.
PubMed 29293481Lee W, Yan YY, Jensen MP, Shun SC, Lin YK, Tsai TP, Lai YH. Predictors and patterns of chronic pain three months after cardiac surgery in Taiwan. Pain Med. 2010 Dec;11(12):1849-58. doi: 10.1111/j.1526-4637.2010.00976.x. Epub 2010 Oct 28.
PubMed 21040435van Gulik L, Janssen LI, Ahlers SJ, Bruins P, Driessen AH, van Boven WJ, van Dongen EP, Knibbe CA. Risk factors for chronic thoracic pain after cardiac surgery via sternotomy. Eur J Cardiothorac Surg. 2011 Dec;40(6):1309-13. doi: 10.1016/j.ejcts.2011.03.039. Epub 2011 May 10.
PubMed 21561786Gust R, Pecher S, Gust A, Hoffmann V, Bohrer H, Martin E. Effect of patient-controlled analgesia on pulmonary complications after coronary artery bypass grafting. Crit Care Med. 1999 Oct;27(10):2218-23. doi: 10.1097/00003246-199910000-00025.
PubMed 10548210Sasseron AB, Figueiredo LC, Trova K, Cardoso AL, Lima NM, Olmos SC, Petrucci O. Does the pain disturb the respiratory function after open heart surgery? Rev Bras Cir Cardiovasc. 2009 Oct-Dec;24(4):490-6. doi: 10.1590/s0102-76382009000500010. English, Portuguese.
PubMed 20305922Mueller XM, Tinguely F, Tevaearai HT, Revelly JP, Chiolero R, von Segesser LK. Pain location, distribution, and intensity after cardiac surgery. Chest. 2000 Aug;118(2):391-6. doi: 10.1378/chest.118.2.391.
PubMed 10936130Lahtinen 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.
PubMed 17006079Milgrom LB, Brooks JA, Qi R, Bunnell K, Wuestfeld S, Beckman D. Pain levels experienced with activities after cardiac surgery. Am J Crit Care. 2004 Mar;13(2):116-25.
PubMed 15043239Mittnacht AJC, Shariat A, Weiner MM, Malhotra A, Miller MA, Mahajan A, Bhatt HV. Regional Techniques for Cardiac and Cardiac-Related Procedures. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):532-546. doi: 10.1053/j.jvca.2018.09.017. Epub 2018 Sep 13. No abstract available.
PubMed 30529177Hemmerling TM, Cyr S, Terrasini N. Epidural catheterization in cardiac surgery: the 2012 risk assessment. Ann Card Anaesth. 2013 Jul-Sep;16(3):169-77. doi: 10.4103/0971-9784.114237.
PubMed 23816670Fujii 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.
PubMed 31360703Fujii S, Roche M, Jones PM, Vissa D, Bainbridge D, Zhou JR. Transversus thoracis muscle plane block in cardiac surgery: a pilot feasibility study. Reg Anesth Pain Med. 2019 May;44(5):556-560. doi: 10.1136/rapm-2018-100178. Epub 2019 Mar 21.
PubMed 30902911Chin KJ. An Anatomical Basis for Naming Plane Blocks of the Anteromedial Chest Wall. Reg Anesth Pain Med. 2017 May/Jun;42(3):414-415. doi: 10.1097/AAP.0000000000000575. No abstract available.
PubMed 28419049Murata H, Hida K, Hara T. Reply to Dr Del Buono et al. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):792. doi: 10.1097/AAP.0000000000000491. No abstract available.
PubMed 27776104Fujii S, Vissa D, Ganapathy S, Johnson M, Zhou J. Transversus Thoracic Muscle Plane Block on a Cadaver With History of Coronary Artery Bypass Grafting. Reg Anesth Pain Med. 2017 Jul/Aug;42(4):535-537. doi: 10.1097/AAP.0000000000000607. No abstract available.
PubMed 28632672
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Pecto-intercostal Fascial Plane Catheters for Reduction of Sternal Pain in Cardiac Surgery Patients With Complete Median Sternotomy: A Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05054179
- Acronym / sponsor ID
- PIFB Catheter RCT
- Conditions
- Cardiac Surgery, Sternotomy, Acute Pain
- Keywords
- Pecto-intercostal fascial plane catheters, Cardiac surgery, Heart surgery, Sternotomy, Acute pain, Post-sternotomy pain, Chronic Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One of the most painful aspects of open heart surgery is the incision made through the skin and the sternum to access the heart (a "sternotomy"). Post-sternotomy pain is a potentially debilitating complication of surgery that slows recovery immediately after surgery and can lead to issues with chronic pain. Previous research has shown that by injecting local anesthesia in the pecto inter-fascial plane, the space between the pectoralis major and the intercostal muscles, pain relief can be provided. The investigators aim to assess if repeated injections of local anesthesia via catheters is a useful adjunct compared to routine care.
Detailed description
Justification:
Post-sternotomy pain after cardiac surgery can be debilitating, with associated risks of decreased respiratory function and chronic pain. Severe acute sternal pain after cardiac surgery occurs in 49% of patients at rest and 78% of patients during coughing. Post-sternotomy pain is worst during the first two days and improves thereafter.
The sternum is innervated by the medial division of the anterior cutaneous branches of the T2-6 intercostal nerves, which may be targeted by several regional anesthetic techniques. Concerns of rare epidural hematoma and possible case cancellations with a bloody tap, in the context of systemic heparinization for cardiac surgery, deters many from utilizing neuraxial analgesia for post-sternotomy pain. Contrarily, parasternal regional blocks such as pecto-intercostal fascial plane block (PIFB) provide a low-risk alternative that targets the anterior cutaneous branches of intercostal nerves, and PIFB has been shown to be effective in improving acute post-sternotomy pain.
Nevertheless, single-shot PIFB is limited by its short duration of action, whereas sternotomy pain can remain severe for two postoperative days. Hence, continuous local anesthetic infusion via bilateral PIFB catheters for 48 hours may improve patient pain experience and related outcomes over single shot PIFB.
Objective:
This study aims to evaluate whether, in addition to single shot PIFB, continuous local anesthetic infusion (compared with placebo infusion) through bilateral PIFB catheters reduces acute sternal pain at 24 hours after cardiac surgery with complete median sternotomy. The 24-hour time point was chosen as it represents a time where both the post-sternotomy pain is rated as severe, especially with movement and coughing, and the patient is required to start actively participating in the postoperative rehabilitative process.
Hypotheses:
This study hypothesize that, in addition to single shot PIFB, continuous ropivacaine infusion through bilateral PIFB catheters will be more effective than placebo infusion in reducing sternal pain score on standardized coughing at 24 hours after cardiac surgery with complete median sternotomy.
Study Design:
This will be a prospective, randomized, triple-blinded, placebo-controlled trial in which patients will be randomly allocated to two study groups on a 1:1 basis into:
- Treatment Group: 20 mL of ropivacaine 0.2% will be deposited via parasternal multi-orifice catheters on each side, followed by infusion of 3 mL/h for 48 hours.
- Control Group: 20 mL of ropivacaine 0.2% will be deposited via parasternal multi-orifice catheters on each side, followed by a saline infusion of 3 mL/h for 48 hours.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a prospective, randomized, triple-blinded, placebo-controlled trial in which patients will be randomly allocated to two study groups on a 1:1 basis into: 1) Intervention Group: 20 mL of ropivacaine 0.2% will be bolused through PIFB catheters on each side, followed by 3 mL/hour infusion of ropivacaine 0.2% for 48 hours each side. 2) Control Group: 20 mL of ropivacaine 0.2% will be bolused through PIFB catheters on each side, followed by 3 mL/hour infusion of normal saline for 48 hours each side.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Ropivacaine 0.2% Injectable Solution Bolus, Drug: Ropivacaine 0.2% Injectable Solution InfusionThe participants of this group will receive 20 mL of 0.2% Ropivacaine via parasternal multi-orifice catheters on each side of the sternum, followed by infusion of 3 mL/h for 48 hours. |
| Placebo group | Placebo comparator | Drug: Ropivacaine 0.2% Injectable Solution Bolus, Other: Normal Saline InfusionThe participants of this group will receive 20 mL of 0.2% Ropivacaine via parasternal multi-orifice catheters on each side of the sternum, followed by infusion of 3 mL/h of normal saline for 48 hours. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled cardiac surgery patients
- Complete median sternotomy
- Adult (19 years old or older)
- English-speaking
Key exclusion criteria (23 listed)
- Preoperative Exclusion Criteria:
- Postoperative Exclusion Criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine 0.2% Injectable Solution Bolus20 mL of ropivacaine 0.2% will be injected via parasternal multi-orifice catheters on each side | Drug | Intervention Group, Placebo group |
| Normal Saline Infusion3 mL/hour infusion of normal saline for 48 hours via parasternal multi-orifice catheters on each side of the sternum | Other | Placebo group |
| Ropivacaine 0.2% Injectable Solution Infusion3 mL/h infusion of Ropivacaine 0.2% for 48 hours via parasternal multi-orifice catheters on each side of the sternum | Drug | Intervention Group |
Primary outcome
Post-operative Sternal Pain on coughing at 24 hours.
Time frame: Post-surgery 24 hours after intervention
Cardiac Surgery Intensive Care Unit nurses or recovery ward nurses will assess and record Numeric Rating Scale (NRS) sternal pain scores on coughing. Coughing will be elicited with a standardized script for a sitting patient: "Please use both hands to hold on to the pillow in front of you to hold your chest in. Take a deep breath in, and give me three coughs in a row" The scale is from 0 to 10, with 0 being no pain at all and 10 being the worst pain possible.
7 secondary outcomes
Cumulative opioid consumption (in IV morphine equivalents)
Time frame: Post-surgery at 24 and 48 hours after intervention
Post-operative sternal pain severity
Time frame: Post surgery, every 8 hours after intervention up to 48 hours
Nausea or vomiting
Time frame: Post-surgery within 48 hours of intervention
Quality of Recovery-15 score (QoR-15)
Time frame: Pre-surgery (at enrolment) and Post-surgery at 48 hours
Chronic sternal pain
Time frame: Post-surgery at 3 months and 6 months
Quality of Life Questionnaire
Time frame: Pre-operatively (at enrolment), 48 hours after intervention and 3 and 6 months after discharge from hospital
Overall Health (EQ-5D VAS)
Time frame: Pre-operatively (at enrolment), 48 hours after intervention and 3 and 6 months after discharge from hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Background: PubMed 29293481Liu V, Mariano ER, Prabhakar C. Pecto-intercostal Fascial Block for Acute Poststernotomy Pain: A Case Report. A A Pract. 2018 Jun 15;10(12):319-322. doi: 10.1213/XAA.0000000000000697.
- Background: PubMed 21040435Lee W, Yan YY, Jensen MP, Shun SC, Lin YK, Tsai TP, Lai YH. Predictors and patterns of chronic pain three months after cardiac surgery in Taiwan. Pain Med. 2010 Dec;11(12):1849-58. doi: 10.1111/j.1526-4637.2010.00976.x. Epub 2010 Oct 28.
- Background: PubMed 21561786van Gulik L, Janssen LI, Ahlers SJ, Bruins P, Driessen AH, van Boven WJ, van Dongen EP, Knibbe CA. Risk factors for chronic thoracic pain after cardiac surgery via sternotomy. Eur J Cardiothorac Surg. 2011 Dec;40(6):1309-13. doi: 10.1016/j.ejcts.2011.03.039. Epub 2011 May 10.
- Background: PubMed 10548210Gust R, Pecher S, Gust A, Hoffmann V, Bohrer H, Martin E. Effect of patient-controlled analgesia on pulmonary complications after coronary artery bypass grafting. Crit Care Med. 1999 Oct;27(10):2218-23. doi: 10.1097/00003246-199910000-00025.
- Background: PubMed 20305922Sasseron AB, Figueiredo LC, Trova K, Cardoso AL, Lima NM, Olmos SC, Petrucci O. Does the pain disturb the respiratory function after open heart surgery? Rev Bras Cir Cardiovasc. 2009 Oct-Dec;24(4):490-6. doi: 10.1590/s0102-76382009000500010. English, Portuguese.
- Background: PubMed 10936130Mueller XM, Tinguely F, Tevaearai HT, Revelly JP, Chiolero R, von Segesser LK. Pain location, distribution, and intensity after cardiac surgery. Chest. 2000 Aug;118(2):391-6. doi: 10.1378/chest.118.2.391.
- Background: PubMed 17006079Lahtinen 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.
- Background: PubMed 15043239Milgrom LB, Brooks JA, Qi R, Bunnell K, Wuestfeld S, Beckman D. Pain levels experienced with activities after cardiac surgery. Am J Crit Care. 2004 Mar;13(2):116-25.
- Background: PubMed 30529177Mittnacht AJC, Shariat A, Weiner MM, Malhotra A, Miller MA, Mahajan A, Bhatt HV. Regional Techniques for Cardiac and Cardiac-Related Procedures. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):532-546. doi: 10.1053/j.jvca.2018.09.017. Epub 2018 Sep 13. No abstract available.
- Background: PubMed 23816670Hemmerling TM, Cyr S, Terrasini N. Epidural catheterization in cardiac surgery: the 2012 risk assessment. Ann Card Anaesth. 2013 Jul-Sep;16(3):169-77. doi: 10.4103/0971-9784.114237.
- Background: PubMed 31360703Fujii 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.
- Background: PubMed 30902911Fujii S, Roche M, Jones PM, Vissa D, Bainbridge D, Zhou JR. Transversus thoracis muscle plane block in cardiac surgery: a pilot feasibility study. Reg Anesth Pain Med. 2019 May;44(5):556-560. doi: 10.1136/rapm-2018-100178. Epub 2019 Mar 21.
- Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) by U.S. Food and Drug AdministrationLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim TH Jen, MD contact
Ron Ree, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ropivacaine 0.2% Injectable Solution Bolus, Normal Saline Infusion and Ropivacaine 0.2% Injectable Solution Infusion in people with Cardiac Surgery and Sternotomy, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola Edwards, MHA (778-870-5520, nedwards@providencehealth.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Sternal Pain on coughing at 24 hours. (time frame: Post-surgery 24 hours after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05054179, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.