Postoperative PainPIPACSNCT05999721
The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery
A study testing superficial parasternal intercostal plane block in people with Postoperative Pain and Pulmonary Function Tests, run by Shai Fein at 2 sites in Israel.
Trial summary
In adult patients undergoing cardiac surgery, does adding an sPIP block to standard care compared to standard care alone result in a smaller decrease in PFTs? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Pulmonary Function Tests
- What is being tested?
- superficial parasternal intercostal plane block
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesIsrael
- Study dates
- 25 Jan 2025to 1 Jan 2027
- 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
- Patients who are scheduled to undergo elective cardiac surgery via sternotomy (i.e., coronary artery bypass graft, valvular surgery, and combined surgery).
- Body Mass Index (BMI) above 20 and below 40 kg m-2
- Age above 18 years.
- Eligible to sign informed consent.
Who cannot join
- Emergency surgery.
- Redo surgery.
- Off-pump surgeries.
- Pregnancy.
- Preoperative mechanical circulatory support (i.e., intra-aortic balloon pump, extracorporeal membrane oxygenation, ventricular assist devices).
- Preoperative chronic pain (i.e., fibromyalgia, chronic neuropathic pain).
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- Contraindication for regional analgesia (i.e., known allergy to LA, skin lesions in the injection site).
- Known allergy to one or more of the components of multimodal analgesia (i.e., opioids, paracetamol, tramadol, dipyrone).
- Preexisting severe pulmonary disease (i.e., an obstructive lung disease with FEV1 below 49%, restrictive lung disease with FVC below 49%, pulmonary hypertension).
- Criteria For Discontinuing (Postoperative Exclusion Criteria):
- Prolonged cardiopulmonary bypass (CPB) of more than three hours.
- Transfusion of more than three units of blood products.
- Severe coagulation disturbance requiring prothrombin complex concentrate or recombinant factor VII.
- Left ventricular failure with vasoactive-inotropic score (VIS) at the end of the surgery of ≥ 20.
- Right ventricular failure requires inhaled nitric oxide.
- Need for mechanical circulatory support (i.e., intra-aortic balloon pump, extracorporeal membrane oxygenation).
- Patients requiring mechanical ventilation for more than 24 hours postoperatively.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel2 sites, 2 recruiting
- Recruiting
Rabin Medical Center, Beilinson Hospital
Petah Tikva
- Not yet recruiting
Rabin Medical Center
Petah Tikva
Shai Fein, MD, MHA
About this study
Official title: The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery (PIPACS Trial): a Prospective, Double-blind, Randomised Controlled Trial.
In adult patients undergoing cardiac surgery, does adding an sPIP block to standard care compared to standard care alone result in a smaller decrease in PFTs?
Read the detailed description
Postoperative pulmonary complications are a significant concern after cardiac surgery, with post-sternotomy pain contributing to impaired pulmonary function and increased risk of these complications. Parasternal intercostal plane blocks have recently emerged as a promising analgesic option for cardiac surgery, but their impact on pulmonary function tests (PFTs) has yet to be evaluated.
This prospective, single-center, double-blind, randomized controlled trial will recruit 100 adult patients undergoing elective cardiac surgery. Baseline pulmonary function, including FEV1, FVC, and PEF, will be measured preoperatively and reassessed on the first postoperative day to evaluate the primary outcome: percentage change in PFT values. Secondary outcomes include pain scores, opioid consumption, incidence of postoperative pulmonary complications during hospitalization, duration of cardiothoracic intensive care and hospital stays, and 30-day mortality.
This study aims to determine whether adding a superficial parasternal intercostal plane (sPIP) block to standard care better preserves pulmonary function in adult patients undergoing elective cardiac surgery.
- Conditions
- Postoperative Pain, Pulmonary Function Tests
- Being tested
- superficial parasternal intercostal plane block, Standard care
- Keywords
- Superficial Parasternal Intercostal Plane Block, Pulmonary function tests, Cardiac surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
superficial parasternal intercostal plane blockProcedure or surgery
Injection of 60 mL of bupivacaine 0.25% and epinephrine 2.5 µg mL-1
Standard careOther
Operating Room:
Anaesthesia will be induced using midazolam (0.1-0.15 mg kg-1), fentanyl (5-10 μg kg-1), and rocuronium (0.6-1.2 mg kg-1); then, after tracheal intubation, anaesthesia will be maintained using isoflurane at one MAC, along with continuous fentanyl (3-5 μg kg-1 h-1) and midazolam (20-50 μg kg-1 h-1). Additional boluses of fentanyl will be administered according to the anesthesiologist's discretion.
Cardiothoracic Intensive Care Unit:
Continuous fentanyl will be maintained until tracheal extubation. All patients will receive intravenous multimodal analgesic drugs around the clock, including paracetamol 3 g day-1 and dipyrone 3 g day-1. If pain persists, rescue doses of either intravenous tramadol or morphine will be administered.
Cardiothoracic ward:
The analgesic protocol includes around-the-clock intravenous paracetamol 3 g day-1 and dipyrone 3 g day-1. If pain continues, rescue doses of oral oxycodone will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Active comparator | In addition to standard care, the treatment arm will receive an ultrasound-guided bilateral single-shot superficial parasternal intercostal plane block at two levels. Receives: Procedure: superficial parasternal intercostal plane block; Other: Standard care |
| Control Arm | Active comparator | The control arm will receive standard care alone. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Forced Expiratory Volume in the First Second (FEV1)
Percentage change in FEV1 (measured in litres) from baseline to the first postoperative day.
Measured: Baseline (preoperative) and first postoperative day
Percentage Change in Forced Vital Capacity (FVC)
Percentage change in FVC (measured in litres) from baseline to the first postoperative day.
Measured: Baseline (preoperative) and first postoperative day
Percentage Change in Peak Expiratory Flow (PEF)
Percentage change in PEF (measured in litres per second) from baseline to the first postoperative day.
Measured: Baseline (preoperative) and first postoperative day
Secondary outcomes (5)
Pain scores, measured by Numeric Rating Scale (NRS)
Maximum pain NRS (0-10) recorded at various time intervals.
Measured: 0-8 hours, 8-16 hours, 16-24 hours, 24-48 hours, and 48-72 hours postoperatively
Opioid consumption, measured in Morphine Milligram Equivalents (MME)
Opioid consumption measured in MME at various time intervals postoperatively.
Measured: 0-8 hours, 8-16 hours, 16-24 hours, 24-48 hours, and 48-72 hours postoperatively
Postoperative pulmonary complication, based on the European perioperative clinical outcome (EPCO) criteria
The incidence of postoperative pulmonary complications during current hospitalisation
Measured: 30 days
Length of stay
The length of cardiothoracic intensive care unit and hospital stay
Measured: 30 days
Mortality
Thirty-day mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start25 Jan 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shai Fein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shai Fein, Rabin Medical Center
- Investigators
- Shai Fein, MD, MHA, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999721
- Sponsor's protocol ID
- 0577-23-RMC
- Acronym
- PIPACS
- Status last verified
- Jul 2026
- First submitted
- 6 Aug 2023
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant-level datasets and statistical code will be provided upon request.
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
- The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery (PIPACS Trial): a Prospective, Double-blind, Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT05999721
- Acronym / sponsor ID
- PIPACS / 0577-23-RMC
- Conditions
- Postoperative Pain, Pulmonary Function Tests
- Keywords
- Superficial Parasternal Intercostal Plane Block, Pulmonary function tests, Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shai FeinUniversity, hospital or other
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 21 Aug 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.
In adult patients undergoing cardiac surgery, does adding an sPIP block to standard care compared to standard care alone result in a smaller decrease in PFTs?
Detailed description
Postoperative pulmonary complications are a significant concern after cardiac surgery, with post-sternotomy pain contributing to impaired pulmonary function and increased risk of these complications. Parasternal intercostal plane blocks have recently emerged as a promising analgesic option for cardiac surgery, but their impact on pulmonary function tests (PFTs) has yet to be evaluated.
This prospective, single-center, double-blind, randomized controlled trial will recruit 100 adult patients undergoing elective cardiac surgery. Baseline pulmonary function, including FEV1, FVC, and PEF, will be measured preoperatively and reassessed on the first postoperative day to evaluate the primary outcome: percentage change in PFT values. Secondary outcomes include pain scores, opioid consumption, incidence of postoperative pulmonary complications during hospitalization, duration of cardiothoracic intensive care and hospital stays, and 30-day mortality.
This study aims to determine whether adding a superficial parasternal intercostal plane (sPIP) block to standard care better preserves pulmonary function in adult patients undergoing elective cardiac surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Active comparator | Procedure: superficial parasternal intercostal plane block, Other: Standard careIn addition to standard care, the treatment arm will receive an ultrasound-guided bilateral single-shot superficial parasternal intercostal plane block at two levels. |
| Control Arm | Active comparator | Other: Standard careThe control arm will receive standard care alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are scheduled to undergo elective cardiac surgery via sternotomy (i.e., coronary artery bypass graft, valvular surgery, and combined surgery).
- Body Mass Index (BMI) above 20 and below 40 kg m-2
- Age above 18 years.
- Eligible to sign informed consent.
Key exclusion criteria (17 listed)
- Emergency surgery.
- Redo surgery.
- Off-pump surgeries.
- Pregnancy.
- Preoperative mechanical circulatory support (i.e., intra-aortic balloon pump, extracorporeal membrane oxygenation, ventricular assist devices).
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 |
|---|---|---|
| superficial parasternal intercostal plane blockInjection of 60 mL of bupivacaine 0.25% and epinephrine 2.5 µg mL-1 | Procedure or surgery | Treatment Arm |
| Standard careOperating Room: Anaesthesia will be induced using midazolam (0.1-0.15 mg kg-1), fentanyl (5-10 μg kg-1), and rocuronium (0.6-1.2 mg kg-1); then, after tracheal intubation, anaesthesia will be maintained using isoflurane at one MAC, along with continuous fentanyl (3-5 μg kg-1 h-1) and midazolam (20-50 μg kg-1 h-1). Additional boluses of fentanyl will be administered according to the anesthesiologist's discretion. Cardiothoracic Intensive Care Unit: Continuous fentanyl will be maintained until tracheal extubation. All patients will receive intravenous multimodal analgesic drugs around the clock, including paracetamol 3 g day-1 and dipyrone 3 g day-1. If pain persists, rescue doses of either intravenous tramadol or morphine will be administered. Cardiothoracic ward: The analgesic protocol includes around-the-clock intravenous paracetamol 3 g day-1 and dipyrone 3 g day-1. If pain continues, rescue doses of oral oxycodone will be administered. | Other | Control Arm, Treatment Arm |
Primary outcome
Percentage Change in Forced Expiratory Volume in the First Second (FEV1)
Time frame: Baseline (preoperative) and first postoperative day
Percentage change in FEV1 (measured in litres) from baseline to the first postoperative day.
Percentage Change in Forced Vital Capacity (FVC)
Time frame: Baseline (preoperative) and first postoperative day
Percentage change in FVC (measured in litres) from baseline to the first postoperative day.
Percentage Change in Peak Expiratory Flow (PEF)
Time frame: Baseline (preoperative) and first postoperative day
Percentage change in PEF (measured in litres per second) from baseline to the first postoperative day.
5 secondary outcomes
Pain scores, measured by Numeric Rating Scale (NRS)
Time frame: 0-8 hours, 8-16 hours, 16-24 hours, 24-48 hours, and 48-72 hours postoperatively
Opioid consumption, measured in Morphine Milligram Equivalents (MME)
Time frame: 0-8 hours, 8-16 hours, 16-24 hours, 24-48 hours, and 48-72 hours postoperatively
Postoperative pulmonary complication, based on the European perioperative clinical outcome (EPCO) criteria
Time frame: 30 days
Length of stay
Time frame: 30 days
Mortality
Time frame: 30 days
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: No. Participant-level datasets and statistical code will be provided upon request.
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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.
Shai Fein, MD, MHA principal investigator
Rabin Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing superficial parasternal intercostal plane block in people with Postoperative Pain and Pulmonary Function Tests, run by Shai Fein at 2 sites in Israel.
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 17 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 2 sites in Israel. 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.
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 Shai Fein, MD, MHA (+972 52 8989630, shaifein812@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Forced Expiratory Volume in the First Second (FEV1) (time frame: Baseline (preoperative) and first postoperative day). 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 9 Jul 2026.