Post-operative PainEPOCHNCT06028126
Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial
A study testing Intermittent Superficial Parasternal Intercostal Plane Block - Experimental in people with Post-operative Pain and Post-operative Delirium, run by Unity Health Toronto at 4 sites in Canada.
Trial summary
The goal of this clinical trial is to assess whether the use of intermittent superficial parasternal intercostal plane blocks reduces opioid usage in patients undergoing cardiac surgery with median sternotomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Pain, Post-operative Delirium, Post-cardiac Surgery
- What is being tested?
- Intermittent Superficial Parasternal Intercostal Plane Block - Experimental
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- 4 sitesCanada
- Study dates
- 8 Sep 2023to 4 Mar 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing cardiac surgery via median sternotomy
Who cannot join
- Redo sternotomy, or cardiac surgery performed through non-sternotomy approaches (minimally invasive procedures, thoracotomies, mini-sternotomy, hemi-sternotomy, etc.)
- Emergency procedures (surgery within 2 hours)
- Clinical instability which in the judgement of the investigator precludes enrollment or participation in the study
- Weight < 50kg
- Active systemic bacterial infection including infective endocarditis or pre-existing sternal infections
- Surgery for infective endocarditis
Show all 11Show fewer
- Pregnancy or nursing
- Chronic opioid/narcotic use > 6 weeks, active use of illicit drugs, long-term opioid exposure or chronic pain disorder/syndromes
- Allergies to amide anesthetic agents or any components of study interventions
- Inability to comply with, or participate in, protocol (i.e. cognitive impairment/altered mental status/neurological deficit or disorder, inability to provide informed consent, inability to complete pain rating scales, etc.)
- Receipt of an investigational drug or device within past 7 days
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Foothills Medical Centre
Calgary, Alberta
QEII Health Sciences Centre
Halifax, Nova Scotia, NS B3H 3A7
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Royal Columbian Hospital
Vancouver, British Columbia
About this study
Official title: Efficacy of Intermittent Superficial Parasternal Intercostal Plane Block on Postoperative Pain Control in Patients Undergoing Cardiac Surgery With Median Sternotomy - EPOCH Randomized Clinical Trial
The goal of this clinical trial is to assess whether the use of intermittent superficial parasternal intercostal plane blocks reduces opioid usage in patients undergoing cardiac surgery with median sternotomy.
Participants randomized to the intervention group will receive the blocks with 0.2% ropivacaine administered via catheters placed in the superficial parasternal intercostal plane bilaterally under ultrasound guidance. Researchers will compare this group with a control group given 0.9% saline through similarly placed catheters. The primary outcome will be cumulative postoperative opioid use (measured as Milligram Morphine Equivalent (MME)) up to 72 hours following catheter insertion.
Read the detailed description
This trial is comparing the use of 0.2% ropivacaine and 0.9% saline through a parasternal intercostal plane block and to measure whether there are any tangible changes in:
- The primary outcome will be cumulative postoperative opioid use (measured as Milligram Morphine Equivalent (MME)) up to 72 hours following catheter insertion. Secondary outcomes will be:
- cumulative postoperative opioid use from catheter insertion up to hospital discharge - measured as MME
- median pain score - measured at rest and with coughing using a standardized numerical rating scale - for 72 hours post catheter insertion
- delirium - assessed twice daily using institutional scores up to 72 hours following catheter insertion.
5.) Quality of Recovery -15 (QoR-15) score 24-96 hours post-surgery
Tertiary outcomes will be:
6.) time from catheter insertion to extubation 7.) time from catheter insertion to first opioid analgesic provision following extubation 8.) time from catheter insertion to mobilization 9.) lengths of stay in the intensive care unit and the hospital 10.) postoperative nausea and vomiting - measured twice a day and antiemetic medication requirements for the 72 hours after catheter insertion 11.) opioid requirements following discharge from the hospital 12.) chronic post-sternotomy pain/disability (McGill Pain Questionnaire) 13.) participant-reported outcomes (PROMIS-29 survey) at 6 weeks and 3 months post surgery
- Conditions
- Post-operative Pain, Post-operative Delirium, Post-cardiac Surgery, Chronic Pain, Opioid Use Disorder, Anesthesia, Local
- Being tested
- Intermittent Superficial Parasternal Intercostal Plane Block - Experimental, Intermittent Superficial Parasternal Intercostal Plane Block - Placebo
- Medical subject headings
- Pain, Postoperative, Emergence Delirium, Chronic Pain, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Superficial Parasternal Intercostal Plane Block - ExperimentalProcedure or surgery
Catheter insertion will be performed by an anesthesiologist with regional block training immediately following skin closure in the operating room. Catheters will be inserted under ultrasound guidance, in a sterile fashion, with a high-frequency linear transducer which will be placed 1 cm lateral to the sternal border in the longitudinal plane in order to view the T4-T5 intercostal space. A Tuohy needle will be used to enter the superficial parasternal intercostal plane, with saline being injected to help visualize the plane between the pectoralis major and intercostal muscles. Subsequently, the catheters will be advanced into the plane, and secured on the skin.
Following initial bolus after catheter placement (20 mL 0.2% ropivacaine), intermittent boluses of 5 mL 0.2% ropivacaine will be delivered via catheters for 48 hours post-catheter insertion per side every 3-4 hours. There will be a basal infusion rate of 0.1-1mL/hr per side.
Intermittent Superficial Parasternal Intercostal Plane Block - PlaceboProcedure or surgery
Catheter insertion will be performed by an anesthesiologist with regional block training immediately following skin closure in the operating room. Catheters will be inserted under ultrasound guidance, in a sterile fashion, with a high-frequency linear transducer which will be placed 1 cm lateral to the sternal border in the longitudinal plane in order to view the T4-T5 intercostal space. A Tuohy needle will be used to enter the superficial parasternal intercostal plane, with saline being injected to help visualize the plane between the pectoralis major and intercostal muscles. Subsequently, the catheters will be advanced into the plane, and secured on the skin.
Following initial bolus dosing after catheter placement (20 mL placebo(0.9% saline)), intermittent boluses of 5 mL Placebo(0.9% saline) will be delivered via catheters for 48 hours post-catheter insertion per side every 3-4 hours. There will be a basal infusion rate of 0.1-1mL/hr per side.
| Study group | Role | What they receive |
|---|---|---|
| 0.2% ropivacaine | Experimental | Intermittent superficial parasternal intercostal plane block via ultrasound-guided catheter placement. Initial bolus dosing of 20 milliliter (mL) of 0.2% ropivacaine per side after catheter placement, followed by intermittent boluses of 5 mL 0.2% ropivacaine per side every 3-4 hours. There will be a basal infusion rate of 0.1-1mL/hr per side. Receives: Procedure: Intermittent Superficial Parasternal Intercostal Plane Block - Experimental |
| 0.9% saline | Placebo comparator | Intermittent superficial parasternal intercostal plane block via ultrasound-guided catheter placement. Initial bolus dosing of 20 milliliter (mL) of placebo(0.9% saline) per side after catheter placement, followed by intermittent boluses of 5 mL placebo(0.9% saline) per side every 3-4 hours. There will be a basal infusion rate of 0.1-1mL/hr per side. Receives: Procedure: Intermittent Superficial Parasternal Intercostal Plane Block - Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative postoperative opioid use up to 72 hours
Postoperative opioid use measured using Milligram Morphine Equivalent(MME) from catheter insertion up to 72 hours.
Measured: 72 hours after catheter insertion.
Secondary outcomes (4)
Median pain score
Measured using visual analog pain scale (minimum 0, maximum 10; higher is worse) twice daily
Measured: over 72 hours post-extubation
Cumulative post-operative opioid use
Measured total opioid use from the time of catheter insertion until discharge from hospital
Measured: Average of 5 days.
Delirium
assessed twice daily using Confusion Assessment Method (positive or negative; positive indicates delirium present) or Intensive Care Unit Delirium Screen Checklist Score (minimum 0, maximum 8; higher scores is worse; score greater than 3 is positive for delirium) or more than one dose antipsychotic drug or clinical diagnosis by psychiatrist.
Measured: for 72 hours following catheter insertion
Quality of Recovery-15 Scale
Assessed using Quality of Recovery-15 Scale (minimum 0, maximum 150; higher scores mean a better outcome)
Measured: 24-96 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start8 Sep 2023
- Primary completion6 Jan 2026
- Study completion4 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Elizabeth II Health Sciences Centre, Foothills Medical Centre, Royal Columbian Hospital Foundation
- Responsible party
- Sponsor
- Investigators
- Ahmad Alli, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028126
- Sponsor's protocol ID
- 23-038
- Acronym
- EPOCH
- Status last verified
- Mar 2026
- First submitted
- 8 Aug 2023
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mueller 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 10936130Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.
PubMed 31054241Zhang Y, Min J, Chen S. Continuous Pecto-Intercostal Fascial Block Provides Effective Analgesia in Patients Undergoing Open Cardiac Surgery: A Randomized Controlled Trial. Pain Med. 2022 Mar 2;23(3):440-447. doi: 10.1093/pm/pnab291.
PubMed 34601602Dost B, De Cassai A, Balzani E, Tulgar S, Ahiskalioglu A. Effects of ultrasound-guided regional anesthesia in cardiac surgery: a systematic review and network meta-analysis. BMC Anesthesiol. 2022 Dec 29;22(1):409. doi: 10.1186/s12871-022-01952-7.
PubMed 36581838Kumar AK, Chauhan S, Bhoi D, Kaushal B. Pectointercostal Fascial Block (PIFB) as a Novel Technique for Postoperative Pain Management in Patients Undergoing Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Jan;35(1):116-122. doi: 10.1053/j.jvca.2020.07.074. Epub 2020 Jul 30.
PubMed 32859487Brown CR, Chen Z, Khurshan F, Groeneveld PW, Desai ND. Development of Persistent Opioid Use After Cardiac Surgery. JAMA Cardiol. 2020 Aug 1;5(8):889-896. doi: 10.1001/jamacardio.2020.1445.
PubMed 32584934Barletta JF. Clinical and economic burden of opioid use for postsurgical pain: focus on ventilatory impairment and ileus. Pharmacotherapy. 2012 Sep;32(9 Suppl):12S-8S. doi: 10.1002/j.1875-9114.2012.01178.x.
PubMed 22956490Bovill JG, Sebel PS, Stanley TH. Opioid analgesics in anesthesia: with special reference to their use in cardiovascular anesthesia. Anesthesiology. 1984 Dec;61(6):731-55.
PubMed 6150663Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.
PubMed 29026331Alli A, Mazer CD, Dennis F, Teoh H, Chin K, Quan A, Hassan SMA, Szarek M, Tran JD, Dhingra NK, Ghiringhelli JP, de Vasconcelos Papa F, Lee Y, Ricci MJ, Verma R, Derry KL, George T, Krishnaraj A, Hess DA, Rotstein OD, Cook RC, Hassan A, Yau TM, Spence JD, Martinka PM, Sutherland K, Gregory AJ, Noss CD, de Jager P, Dougherty JL, Arora RC, Verma S. Superficial parasternal intercostal plane block with ropivacaine versus placebo for opioid exposure after cardiac surgery (EPOCH CardioLink-10): a multicentre, double-blind, randomised trial. Lancet Reg Health Am. 2026 May 28;60:101508. doi: 10.1016/j.lana.2026.101508. eCollection 2026 Aug.
PubMed 42256617
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intermittent Superficial Parasternal Intercostal Plane Block on Postoperative Pain Control in Patients Undergoing Cardiac Surgery With Median Sternotomy - EPOCH Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06028126
- Acronym / sponsor ID
- EPOCH / 23-038
- Conditions
- Post-operative Pain, Post-operative Delirium, Post-cardiac Surgery, Chronic Pain, Opioid Use Disorder, Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Queen Elizabeth II Health Sciences Centre, Foothills Medical Centre, Royal Columbian Hospital Foundation
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 6 Jan 2026 (actual)
- Study completion
- 4 Mar 2026 (actual)
- First posted
- 8 Sep 2023 (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.
The goal of this clinical trial is to assess whether the use of intermittent superficial parasternal intercostal plane blocks reduces opioid usage in patients undergoing cardiac surgery with median sternotomy.
Participants randomized to the intervention group will receive the blocks with 0.2% ropivacaine administered via catheters placed in the superficial parasternal intercostal plane bilaterally under ultrasound guidance. Researchers will compare this group with a control group given 0.9% saline through similarly placed catheters. The primary outcome will be cumulative postoperative opioid use (measured as Milligram Morphine Equivalent (MME)) up to 72 hours following catheter insertion.
Detailed description
This trial is comparing the use of 0.2% ropivacaine and 0.9% saline through a parasternal intercostal plane block and to measure whether there are any tangible changes in:
- The primary outcome will be cumulative postoperative opioid use (measured as Milligram Morphine Equivalent (MME)) up to 72 hours following catheter insertion. Secondary outcomes will be:
- cumulative postoperative opioid use from catheter insertion up to hospital discharge - measured as MME
- median pain score - measured at rest and with coughing using a standardized numerical rating scale - for 72 hours post catheter insertion
- delirium - assessed twice daily using institutional scores up to 72 hours following catheter insertion.
5.) Quality of Recovery -15 (QoR-15) score 24-96 hours post-surgery
Tertiary outcomes will be:
6.) time from catheter insertion to extubation 7.) time from catheter insertion to first opioid analgesic provision following extubation 8.) time from catheter insertion to mobilization 9.) lengths of stay in the intensive care unit and the hospital 10.) postoperative nausea and vomiting - measured twice a day and antiemetic medication requirements for the 72 hours after catheter insertion 11.) opioid requirements following discharge from the hospital 12.) chronic post-sternotomy pain/disability (McGill Pain Questionnaire) 13.) participant-reported outcomes (PROMIS-29 survey) at 6 weeks and 3 months post surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.2% ropivacaine | Experimental | Procedure: Intermittent Superficial Parasternal Intercostal Plane Block - ExperimentalIntermittent superficial parasternal intercostal plane block via ultrasound-guided catheter placement. Initial bolus dosing of 20 milliliter (mL) of 0.2% ropivacaine per side after catheter placement, followed by intermittent boluses of 5 mL 0.2% ropivacaine per side every 3-4 hours. There will be a basal infusion rate of 0.1-1mL/hr per side. |
| 0.9% saline | Placebo comparator | Procedure: Intermittent Superficial Parasternal Intercostal Plane Block - PlaceboIntermittent superficial parasternal intercostal plane block via ultrasound-guided catheter placement. Initial bolus dosing of 20 milliliter (mL) of placebo(0.9% saline) per side after catheter placement, followed by intermittent boluses of 5 mL placebo(0.9% saline) per side every 3-4 hours. There will be a basal infusion rate of 0.1-1mL/hr per side. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing cardiac surgery via median sternotomy
Key exclusion criteria (11 listed)
- Redo sternotomy, or cardiac surgery performed through non-sternotomy approaches (minimally invasive procedures, thoracotomies, mini-sternotomy, hemi-sternotomy, etc.)
- Emergency procedures (surgery within 2 hours)
- Clinical instability which in the judgement of the investigator precludes enrollment or participation in the study
- Weight < 50kg
- Active systemic bacterial infection including infective endocarditis or pre-existing sternal infections
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 |
|---|---|---|
| Intermittent Superficial Parasternal Intercostal Plane Block - ExperimentalCatheter insertion will be performed by an anesthesiologist with regional block training immediately following skin closure in the operating room. Catheters will be inserted under ultrasound guidance, in a sterile fashion, with a high-frequency linear transducer which will be placed 1 cm lateral to the sternal border in the longitudinal plane in order to view the T4-T5 intercostal space. A Tuohy needle will be used to enter the superficial parasternal intercostal plane, with saline being injected to help visualize the plane between the pectoralis major and intercostal muscles. Subsequently, the catheters will be advanced into the plane, and secured on the skin. Following initial bolus after catheter placement (20 mL 0.2% ropivacaine), intermittent boluses of 5 mL 0.2% ropivacaine will be delivered via catheters for 48 hours post-catheter insertion per side every 3-4 hours. There will be a basal infusion rate of 0.1-1mL/hr per side. | Procedure or surgery | 0.2% ropivacaine |
| Intermittent Superficial Parasternal Intercostal Plane Block - PlaceboCatheter insertion will be performed by an anesthesiologist with regional block training immediately following skin closure in the operating room. Catheters will be inserted under ultrasound guidance, in a sterile fashion, with a high-frequency linear transducer which will be placed 1 cm lateral to the sternal border in the longitudinal plane in order to view the T4-T5 intercostal space. A Tuohy needle will be used to enter the superficial parasternal intercostal plane, with saline being injected to help visualize the plane between the pectoralis major and intercostal muscles. Subsequently, the catheters will be advanced into the plane, and secured on the skin. Following initial bolus dosing after catheter placement (20 mL placebo(0.9% saline)), intermittent boluses of 5 mL Placebo(0.9% saline) will be delivered via catheters for 48 hours post-catheter insertion per side every 3-4 hours. There will be a basal infusion rate of 0.1-1mL/hr per side. | Procedure or surgery | 0.9% saline |
Primary outcome
Cumulative postoperative opioid use up to 72 hours
Time frame: 72 hours after catheter insertion.
Postoperative opioid use measured using Milligram Morphine Equivalent(MME) from catheter insertion up to 72 hours.
4 secondary outcomes
Median pain score
Time frame: over 72 hours post-extubation
Cumulative post-operative opioid use
Time frame: Average of 5 days.
Delirium
Time frame: for 72 hours following catheter insertion
Quality of Recovery-15 Scale
Time frame: 24-96 hours post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- 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 31054241Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.
- Background: PubMed 34601602Zhang Y, Min J, Chen S. Continuous Pecto-Intercostal Fascial Block Provides Effective Analgesia in Patients Undergoing Open Cardiac Surgery: A Randomized Controlled Trial. Pain Med. 2022 Mar 2;23(3):440-447. doi: 10.1093/pm/pnab291.
- Background: PubMed 36581838Dost B, De Cassai A, Balzani E, Tulgar S, Ahiskalioglu A. Effects of ultrasound-guided regional anesthesia in cardiac surgery: a systematic review and network meta-analysis. BMC Anesthesiol. 2022 Dec 29;22(1):409. doi: 10.1186/s12871-022-01952-7.
- Background: PubMed 32859487Kumar AK, Chauhan S, Bhoi D, Kaushal B. Pectointercostal Fascial Block (PIFB) as a Novel Technique for Postoperative Pain Management in Patients Undergoing Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Jan;35(1):116-122. doi: 10.1053/j.jvca.2020.07.074. Epub 2020 Jul 30.
- Background: PubMed 32584934Brown CR, Chen Z, Khurshan F, Groeneveld PW, Desai ND. Development of Persistent Opioid Use After Cardiac Surgery. JAMA Cardiol. 2020 Aug 1;5(8):889-896. doi: 10.1001/jamacardio.2020.1445.
- Background: PubMed 22956490Barletta JF. Clinical and economic burden of opioid use for postsurgical pain: focus on ventilatory impairment and ileus. Pharmacotherapy. 2012 Sep;32(9 Suppl):12S-8S. doi: 10.1002/j.1875-9114.2012.01178.x.
- Background: PubMed 6150663Bovill JG, Sebel PS, Stanley TH. Opioid analgesics in anesthesia: with special reference to their use in cardiovascular anesthesia. Anesthesiology. 1984 Dec;61(6):731-55.
- Background: PubMed 29026331Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017.
- Derived from this study: PubMed 42256617Alli A, Mazer CD, Dennis F, Teoh H, Chin K, Quan A, Hassan SMA, Szarek M, Tran JD, Dhingra NK, Ghiringhelli JP, de Vasconcelos Papa F, Lee Y, Ricci MJ, Verma R, Derry KL, George T, Krishnaraj A, Hess DA, Rotstein OD, Cook RC, Hassan A, Yau TM, Spence JD, Martinka PM, Sutherland K, Gregory AJ, Noss CD, de Jager P, Dougherty JL, Arora RC, Verma S. Superficial parasternal intercostal plane block with ropivacaine versus placebo for opioid exposure after cardiac surgery (EPOCH CardioLink-10): a multicentre, double-blind, randomised trial. Lancet Reg Health Am. 2026 May 28;60:101508. doi: 10.1016/j.lana.2026.101508. eCollection 2026 Aug.
- Individual participant dataSharing planned: No
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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.
Ahmad Alli, MD principal investigator
Unity Health Toronto
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Superficial Parasternal Intercostal Plane Block - Experimental in people with Post-operative Pain and Post-operative Delirium, run by Unity Health Toronto at 4 sites 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 1 inclusion and 11 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: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative postoperative opioid use up to 72 hours (time frame: 72 hours after catheter insertion.). 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 NCT06028126, which also lists 10 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 6 Mar 2026.