Cardiac SurgeryEarly Phase 1NCT04985500
ESP/PIF for Sternotomy
A Early Phase 1 study testing ESP block, PIF block and Ultrasound in people with Cardiac Surgery and Sternotomy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This is a randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of two types of peripheral nerve blocks, specifically erector spinal plane (ESP) block and pecto-intercostal fascial (PIF) plane block. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiac Surgery, Sternotomy
- What is being tested?
- ESP block, PIF block and Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2021to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18-85 years old
- Scheduled to undergo cardiac procedures involving sternotomy
- All genders
Who cannot join
- ASA class V
- Urgent or emergent surgery
- Contraindications to administration of local anesthesia (e.g. local anesthetic allergy)
- History of substance abuse or chronic opioid use
- Patient refusal or inability to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Morningside Hospital
New York, New York, 10025
About this study
Official title: Erector Spinae Plane Block vs. Pecto-intercostal Fascial Plane Block vs. Control for Sternotomy: A Prospective Randomized Trial
This is a randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of two types of peripheral nerve blocks, specifically erector spinal plane (ESP) block and pecto-intercostal fascial (PIF) plane block.
90 subjects, from 18-85 years of age, undergoing cardiac surgery with median sternal incision will be enrolled at Mount Sinai Morningside Hospital Center. Study participation will last from the time of pre-operative evaluation to 72 hours after surgery. Subjects will be randomly assigned to receive 1 of the 3 different regimens at the beginning of surgery. Opioid consumption and pain scores after surgery will be evaluated. Though unlikely, risks include systemic absorption of local anesthetic, which can result in both central nervous system and cardiac toxicity.
- Conditions
- Cardiac Surgery, Sternotomy
- Being tested
- ESP block, PIF block, Ultrasound, Bupivacain
- Keywords
- ESP Block, PIF Block, Cardiac Surgery, Sternotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP blockProcedure or surgery
Also called erector spinal plane block
peripheral nerve block
PIF blockProcedure or surgery
Also called pecto-intercostal fascial plane block
peripheral nerve block
UltrasoundProcedure or surgery
Ultrasound guidance
BupivacainDrug
10-20 mL of 0.25% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| ESP group | Experimental | Patient will receive ESP block with ultrasound guidance the transverse process of the vertebra at T7 is visualized and 20 mL of 0.25% bupivacaine will be injected between the transverse process and the erector spinae muscle on each side using a 21-gauge block needle. Receives: Procedure: ESP block; Procedure: Ultrasound; Drug: Bupivacain |
| PIF group | Experimental | Patient will receive PIF block after intubation with ultrasound placed 1-2 cm lateral to the sternal border and the pectoralis major and external intercostal muscles are visualized at the level of ribs 3-4 where 10 mL of 0.25% bupivacaine will be injected on each side using a 21-gauge block needle. Receives: Procedure: PIF block; Procedure: Ultrasound; Drug: Bupivacain |
| No Block group | No intervention | Patient will not receive block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption during first 24 hours post-op
The amount of opioid consumption (in mg IV morphine equivalents) during the first 24 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
Measured: Post-operative 24 hours
Opioid Consumption during first 48 hours post-op
The amount of opioid consumption (in mg IV morphine equivalents) during the first 48 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
Measured: Post-operative 48 hours
Opioid Consumption during first 72 hours post-op
The amount of opioid consumption (in mg IV morphine equivalents) during the first 72 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
Measured: Post-operative 72 hours
Secondary outcomes (3)
Visual Analogue Score (VAS) Pain Score post-op 24 hours
VAS Pain Score from 0-10, with higher score indicating more pain. The average VAS pain scores during the first 24 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
Measured: Post-operative 24 hours
Visual Analogue Score (VAS) Pain Score post-op 48 hours
VAS Pain Score from 0-10, with higher score indicating more pain. The average VAS pain scores during the first 48 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
Measured: Post-operative 48 hours
Visual Analogue Score (VAS) Pain Score post-op 72 hours
VAS Pain Score from 0-10, with higher score indicating more pain. The average VAS pain scores during the first 72 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
Measured: Post-operative 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start9 Jul 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Patients will be assigned randomly using a computer-generated table of numbers to one of the three groups: 1) ESP group, 2) PIF group, or 3) no block group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Nima Shariat, Icahn School of Medicine at Mount Sinai
- Investigators
- Ali Shariat, M.D., Principal investigator, Mount Sinai West and Morningside HospitalsHimani Bhatt, D.O., Study director, Mount Sinai West and Morningside HospitalsShenghao Fang, M.D., Study director, Mount Sinai West and Morningside Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985500
- Sponsor's protocol ID
- STUDY-20-01473
- Status last verified
- Jun 2026
- First submitted
- 6 Jul 2021
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block vs. Pecto-intercostal Fascial Plane Block vs. Control for Sternotomy: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04985500
- Acronym / sponsor ID
- STUDY-20-01473
- Conditions
- Cardiac Surgery, Sternotomy
- Keywords
- ESP Block, PIF Block, Cardiac Surgery, Sternotomy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Aug 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.
This is a randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of two types of peripheral nerve blocks, specifically erector spinal plane (ESP) block and pecto-intercostal fascial (PIF) plane block.
90 subjects, from 18-85 years of age, undergoing cardiac surgery with median sternal incision will be enrolled at Mount Sinai Morningside Hospital Center. Study participation will last from the time of pre-operative evaluation to 72 hours after surgery. Subjects will be randomly assigned to receive 1 of the 3 different regimens at the beginning of surgery. Opioid consumption and pain scores after surgery will be evaluated. Though unlikely, risks include systemic absorption of local anesthetic, which can result in both central nervous system and cardiac toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be assigned randomly using a computer-generated table of numbers to one of the three groups: 1) ESP group, 2) PIF group, or 3) no block group.
| Arm | Type | Receives |
|---|---|---|
| ESP group | Experimental | Procedure: ESP block, Procedure: Ultrasound, Drug: BupivacainPatient will receive ESP block with ultrasound guidance the transverse process of the vertebra at T7 is visualized and 20 mL of 0.25% bupivacaine will be injected between the transverse process and the erector spinae muscle on each side using a 21-gauge block needle. |
| PIF group | Experimental | Procedure: PIF block, Procedure: Ultrasound, Drug: BupivacainPatient will receive PIF block after intubation with ultrasound placed 1-2 cm lateral to the sternal border and the pectoralis major and external intercostal muscles are visualized at the level of ribs 3-4 where 10 mL of 0.25% bupivacaine will be injected on each side using a 21-gauge block needle. |
| No Block group | No intervention | –Patient will not receive block. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18-85 years old
- Scheduled to undergo cardiac procedures involving sternotomy
- All genders
Key exclusion criteria (5 listed)
- ASA class V
- Urgent or emergent surgery
- Contraindications to administration of local anesthesia (e.g. local anesthetic allergy)
- History of substance abuse or chronic opioid use
- Patient refusal or inability to consent
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 |
|---|---|---|
| ESP blockAlso: erector spinal plane blockperipheral nerve block | Procedure or surgery | ESP group |
| PIF blockAlso: pecto-intercostal fascial plane blockperipheral nerve block | Procedure or surgery | PIF group |
| UltrasoundUltrasound guidance | Procedure or surgery | ESP group, PIF group |
| Bupivacain10-20 mL of 0.25% bupivacaine | Drug | ESP group, PIF group |
Primary outcome
Opioid Consumption during first 24 hours post-op
Time frame: Post-operative 24 hours
The amount of opioid consumption (in mg IV morphine equivalents) during the first 24 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
Opioid Consumption during first 48 hours post-op
Time frame: Post-operative 48 hours
The amount of opioid consumption (in mg IV morphine equivalents) during the first 48 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
Opioid Consumption during first 72 hours post-op
Time frame: Post-operative 72 hours
The amount of opioid consumption (in mg IV morphine equivalents) during the first 72 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
3 secondary outcomes
Visual Analogue Score (VAS) Pain Score post-op 24 hours
Time frame: Post-operative 24 hours
Visual Analogue Score (VAS) Pain Score post-op 48 hours
Time frame: Post-operative 48 hours
Visual Analogue Score (VAS) Pain Score post-op 72 hours
Time frame: Post-operative 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- 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.
Ali Shariat, M.D. principal investigator
Mount Sinai West and Morningside Hospitals
Himani Bhatt, D.O. study director
Mount Sinai West and Morningside Hospitals
Shenghao Fang, M.D. study director
Mount Sinai West and Morningside Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ESP block, PIF block and Ultrasound in people with Cardiac Surgery and Sternotomy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Opioid Consumption during first 24 hours post-op (time frame: Post-operative 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026.