Autonomic Nerve BlockNCT06233318
Sternotomy PIFB Block in Open Heart Surgery
A study testing Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine and Pecto-intercostal Fascial Block with normal saline in people with Autonomic Nerve Block, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if the use of a bilateral nerve block with a local anesthetic (ropivacaine), as part of a standard of care pain control regimen (called multimodal analgesia [MMA]), has a favorable effect on our institutional MMA pain regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autonomic Nerve Block
- What is being tested?
- Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine and Pecto-intercostal Fascial Block with normal saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2023to 31 Jan 2029
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female patients aged > 18
- Undergoing primary cardiac surgery requiring sternotomy
- Able to provide a signed written informed consent
- Able to speak, read, and write in English
- American Society of Anesthesiologists (ASA) physical status I-IV
Who cannot join
- Any documented cognitive or psychological disorders that, in the opinion of the principal investigator, can interfere with the patients' pain perception
- Diabetes Mellitus with documented neuropathic pain
- Vulnerable populations: pregnant females, prisoners, breast feeding
- Contraindication to nerve block: local infections, bleeding disorders, chest wall deformity, allergy to local anesthetic or dexamethasone
- Previous cardiac surgery
- Previous history of chronic pain diseases requiring consistent analgesic therapy for at least 1 month prior to surgery
- Presence of any medical condition that, in the opinion of the principal investigator, should exclude the patient from the study
- BMI ≥ 40 kg/m2
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Alberto A Uribe, 6142930775, alberto.uribe@osumc.edu
Jeremy Reeves, 6142933559, jeremy.reeves@osumc.edu
About this study
Official title: Efficacy of Bilateral Pecto-Intercostal Fascial Plane Block on Postoperative Pain in Adult Patients Undergoing Open Heart Surgery: A Randomized, Double-blind, Controlled Trial
The purpose of this study is to evaluate if the use of a bilateral nerve block with a local anesthetic (ropivacaine), as part of a standard of care pain control regimen (called multimodal analgesia [MMA]), has a favorable effect on our institutional MMA pain regimen. Subjects will go through the following study procedures: review of medical history and medications subjects have taken within a month prior to surgery. Subjects will be randomly assigned to one of the two study groups (1:1) to receive either, an ultrasound-guided bilateral nerve block (called "Pecto-Intercostal Fascial Block [PIFB]") with ropivacaine or saline 0.9 solution, in addition to our institutional MMA regimen. A baseline line pain and nausea scores will be recorded before surgery. The block will be performed right after general anesthesia induction. The details about the surgery will be collected. Pain assessments, nausea and vomiting scores will be registered at 12, 24 and 48 hours after surgery as well. Lastly, a follow up phone call will be made by the research team to conduct a pain-detect questionnaire at 30, 60 and 90 days after surgery.
Read the detailed description
Study design This is a single-center, prospective, randomized, placebo-controlled, double-blinded trial in patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center. All study procedures will be done in accordance with institutional and ORRP-IRB guidelines.
Study participants Adult patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center with an American Society of Anesthesiologists (ASA) physical status of I to IV who are scheduled to undergo open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center.
Sample size Eighty-four subjects who give written informed consent to participate in the study and who meet all inclusion and no exclusion criteria will be included in a single treatment group.
- Conditions
- Autonomic Nerve Block
- Being tested
- Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine, Pecto-intercostal Fascial Block with normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaineProcedure or surgery
The US probe will be placed at sagittal plane, 2 cm lateral to the midline of the sternum to identify the second to the fifth costal cartilage from the ribs. Consequently, the US probe will be positioned in the space between the fourth and fifth costal cartilages at the sternum. After identifying the fascial planes of the chest wall, the pectoralis major muscle (PMM), the external intercostal muscle (EIM), the costal cartilage, the pleura, and the lungs. A sterile 22G blunt Stimuplex, 50 mm needle (B. Braun, Bethlehem, Pa) will be advanced and placed under the PMM and above the EIM. Following negative aspiration, PN solution with investigational product according to group randomization/allocation will be injected at each side in 5 mL aliquots ensuring appropriate spread of the PN solution. The separation of the fascial plane and the spread of the drug will be observed on the ultrasound image in real time.
Pecto-intercostal Fascial Block with normal salineProcedure or surgery
The US probe will be placed at sagittal plane, 2 cm lateral to the midline of the sternum to identify the second to the fifth costal cartilage from the ribs. Consequently, the US probe will be positioned in the space between the fourth and fifth costal cartilages at the sternum. After identifying the fascial planes of the chest wall, the pectoralis major muscle (PMM), the external intercostal muscle (EIM), the costal cartilage, the pleura, and the lungs. A sterile 22G blunt Stimuplex, 50 mm needle (B. Braun, Bethlehem, Pa) will be advanced and placed under the PMM and above the EIM. Following negative aspiration, PN solution with investigational product according to group randomization/allocation will be injected at each side in 5 mL aliquots ensuring appropriate spread of the PN solution. The separation of the fascial plane and the spread of the drug will be observed on the ultrasound image in real time.
| Study group | Role | What they receive |
|---|---|---|
| Pecto-intercostal fascial block | Active comparator | Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine injected to each side under ultrasound visualization. Receives: Procedure: Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine |
| Placebo | Placebo comparator | Pecto-intercostal Fascial Block with 20ml of normal saline injected to each side under ultrasound visualization. Receives: Procedure: Pecto-intercostal Fascial Block with normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
OPIOID consumption at 24 hours
To compare the effect of bilateral PIFB on perioperative opioid consumption (MME) during the first 24 hours after surgery between groups
Measured: 24 hours after block procedure
OPIOID consumption during surgery
To compare the amount of opioid consumption oral MME consumption during surgery between groups
Measured: Surgery length
NRS pain score at 48 hours
To compare the NRS (0-10) pain score up to 48 hours
Measured: Up to 48 hours after block procedure
Worst pain score at 48 hours
To compare the worst pain experienced during up to 48-hours after surgery between groups
Measured: Up to 48 hours after block procedure
Incidence nausea and/or vomiting after surgery
To compare the incidence of nausea and/or vomiting up to 48-hours after surgery between both groups
Measured: Up to 48 hours after block procedure
Self-reported satisfaction score at 48 hours
To compare self-reported patient satisfaction up to 48 hours after surgery between both groups
Measured: 48 hours after block procedure
pain-DETECT scores at 90 days
To compare the "pain-DETECT" questionnaire scores prior to surgery (baseline) and 30 ± 7, 60 ± 7 and 90 ± 7 days after surgery between groups
Measured: Up to 90 days after block procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start16 Oct 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Nerve BlockStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, prospective, randomized, placebo-controlled, double-blinded trial in patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center. All study procedures will be done in accordance with institutional and ORRP-IRB guidelines.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erica Stein, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233318
- Sponsor's protocol ID
- 2023H0076
- Status last verified
- Jun 2026
- First submitted
- 12 Jan 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We estimate that a calculated sample size of 42 patients per group: PN ropivacaine and PN saline (control group)is required for a statistical power of 0.90 and a type I error of 0.05, to detect a 15% reduction (65 μg vs 55 μg, SD=13) in MME use between groups, accounting for 90% successful block rate and 10% of loss to follow-up; a total of 84 patients will be included. The primary outcome of mean MME of pain will be compared between the groups using a two-sample t-test or non-parametric equivalent. Continuous secondary outcomes will be analyzed using the same methods. Categorical secondary outcomes will be analyzed using Chi-square test/Fisher's Exact tests.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Bilateral Pecto-Intercostal Fascial Plane Block on Postoperative Pain in Adult Patients Undergoing Open Heart Surgery: A Randomized, Double-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT06233318
- Acronym / sponsor ID
- 2023H0076
- Conditions
- Autonomic Nerve Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 31 Jan 2024 (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 purpose of this study is to evaluate if the use of a bilateral nerve block with a local anesthetic (ropivacaine), as part of a standard of care pain control regimen (called multimodal analgesia [MMA]), has a favorable effect on our institutional MMA pain regimen. Subjects will go through the following study procedures: review of medical history and medications subjects have taken within a month prior to surgery. Subjects will be randomly assigned to one of the two study groups (1:1) to receive either, an ultrasound-guided bilateral nerve block (called "Pecto-Intercostal Fascial Block [PIFB]") with ropivacaine or saline 0.9 solution, in addition to our institutional MMA regimen. A baseline line pain and nausea scores will be recorded before surgery. The block will be performed right after general anesthesia induction. The details about the surgery will be collected. Pain assessments, nausea and vomiting scores will be registered at 12, 24 and 48 hours after surgery as well. Lastly, a follow up phone call will be made by the research team to conduct a pain-detect questionnaire at 30, 60 and 90 days after surgery.
Detailed description
Study design This is a single-center, prospective, randomized, placebo-controlled, double-blinded trial in patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center. All study procedures will be done in accordance with institutional and ORRP-IRB guidelines.
Study participants Adult patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center with an American Society of Anesthesiologists (ASA) physical status of I to IV who are scheduled to undergo open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center.
Sample size Eighty-four subjects who give written informed consent to participate in the study and who meet all inclusion and no exclusion criteria will be included in a single treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-center, prospective, randomized, placebo-controlled, double-blinded trial in patients undergoing open-heart surgery at Richard M. Ross Hospital - The Ohio State University Medical Center. All study procedures will be done in accordance with institutional and ORRP-IRB guidelines.
| Arm | Type | Receives |
|---|---|---|
| Pecto-intercostal fascial block | Active comparator | Procedure: Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacainePecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine injected to each side under ultrasound visualization. |
| Placebo | Placebo comparator | Procedure: Pecto-intercostal Fascial Block with normal salinePecto-intercostal Fascial Block with 20ml of normal saline injected to each side under ultrasound visualization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult male or female patients aged > 18
- Undergoing primary cardiac surgery requiring sternotomy
- Able to provide a signed written informed consent
- Able to speak, read, and write in English
- American Society of Anesthesiologists (ASA) physical status I-IV
Key exclusion criteria (8 listed)
- Any documented cognitive or psychological disorders that, in the opinion of the principal investigator, can interfere with the patients' pain perception
- Diabetes Mellitus with documented neuropathic pain
- Vulnerable populations: pregnant females, prisoners, breast feeding
- Contraindication to nerve block: local infections, bleeding disorders, chest wall deformity, allergy to local anesthetic or dexamethasone
- Previous cardiac surgery
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 |
|---|---|---|
| Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaineThe US probe will be placed at sagittal plane, 2 cm lateral to the midline of the sternum to identify the second to the fifth costal cartilage from the ribs. Consequently, the US probe will be positioned in the space between the fourth and fifth costal cartilages at the sternum. After identifying the fascial planes of the chest wall, the pectoralis major muscle (PMM), the external intercostal muscle (EIM), the costal cartilage, the pleura, and the lungs. A sterile 22G blunt Stimuplex, 50 mm needle (B. Braun, Bethlehem, Pa) will be advanced and placed under the PMM and above the EIM. Following negative aspiration, PN solution with investigational product according to group randomization/allocation will be injected at each side in 5 mL aliquots ensuring appropriate spread of the PN solution. The separation of the fascial plane and the spread of the drug will be observed on the ultrasound image in real time. | Procedure or surgery | Pecto-intercostal fascial block |
| Pecto-intercostal Fascial Block with normal salineThe US probe will be placed at sagittal plane, 2 cm lateral to the midline of the sternum to identify the second to the fifth costal cartilage from the ribs. Consequently, the US probe will be positioned in the space between the fourth and fifth costal cartilages at the sternum. After identifying the fascial planes of the chest wall, the pectoralis major muscle (PMM), the external intercostal muscle (EIM), the costal cartilage, the pleura, and the lungs. A sterile 22G blunt Stimuplex, 50 mm needle (B. Braun, Bethlehem, Pa) will be advanced and placed under the PMM and above the EIM. Following negative aspiration, PN solution with investigational product according to group randomization/allocation will be injected at each side in 5 mL aliquots ensuring appropriate spread of the PN solution. The separation of the fascial plane and the spread of the drug will be observed on the ultrasound image in real time. | Procedure or surgery | Placebo |
Primary outcome
OPIOID consumption at 24 hours
Time frame: 24 hours after block procedure
To compare the effect of bilateral PIFB on perioperative opioid consumption (MME) during the first 24 hours after surgery between groups
OPIOID consumption during surgery
Time frame: Surgery length
To compare the amount of opioid consumption oral MME consumption during surgery between groups
NRS pain score at 48 hours
Time frame: Up to 48 hours after block procedure
To compare the NRS (0-10) pain score up to 48 hours
Worst pain score at 48 hours
Time frame: Up to 48 hours after block procedure
To compare the worst pain experienced during up to 48-hours after surgery between groups
Incidence nausea and/or vomiting after surgery
Time frame: Up to 48 hours after block procedure
To compare the incidence of nausea and/or vomiting up to 48-hours after surgery between both groups
Self-reported satisfaction score at 48 hours
Time frame: 48 hours after block procedure
To compare self-reported patient satisfaction up to 48 hours after surgery between both groups
pain-DETECT scores at 90 days
Time frame: Up to 90 days after block procedure
To compare the "pain-DETECT" questionnaire scores prior to surgery (baseline) and 30 ± 7, 60 ± 7 and 90 ± 7 days after surgery between groups
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 9 Jul 2026.
- Individual participant dataSharing planned: Undecided. We estimate that a calculated sample size of 42 patients per group: PN ropivacaine and PN saline (control group)is required for a statistical power of 0.90 and a type I error of 0.05, to detect a 15% reduction (65 μg vs 55 μg, SD=13) in MME use between groups, accounting for 90% successful block rate and 10% of loss to follow-up; a total of 84 patients will be included. The primary outcome of mean MME of pain will be compared between the groups using a two-sample t-test or non-parametric equivalent. Continuous secondary outcomes will be analyzed using the same methods. Categorical secondary outcomes will be analyzed using Chi-square test/Fisher's Exact tests.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine and Pecto-intercostal Fascial Block with normal saline in people with Autonomic Nerve Block, run by Ohio State University 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 9 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. 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?
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?
Contact Alberto A Uribe (6142930775, alberto.uribe@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OPIOID consumption at 24 hours (time frame: 24 hours after block procedure). The study lists 7 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 9 Jul 2026.