AnalgesiaNCT06322810
ESP Versus PIFB for Analgesia in Open Cardiac Surgery: a Randomized Control Trial
A study testing Erector spinae plane block (ESPB) and Pecto-intercostal fascial plane blok (PIFB) in people with Analgesia, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
This clinical trial compares analgesia efficiency and recovery outcomes between two different fascial plane block techniques (ESPB vs.PIFB) in cardiac surgery patients participant population/health conditions]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia
- What is being tested?
- Erector spinae plane block (ESPB) and Pecto-intercostal fascial plane blok (PIFB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Nov 2024to 31 Dec 2026
- 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
- Adults patients, elective and first-time cardiac surgery patients undergoing traditional sternotomy. Procedures include coronary artery bypass surgery, valve repair or replacement surgery, atrial and ventricular septal defect repair surgery, and other open-heart surgeries.
Who cannot join
- 1. Emergency surgery 2. Anticipated combined major aortic vascular surgery 3. Already admitted to the ICU or on a ventilator before surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, Taiwan, 407
Yi-Ting Chang, MD, (+886)4-23592525 ext. 4101, taco@vghtc.gov.tw
Yi-Ting Chang, (+886)4-23592525 ext. 4101, taco@vghtc.gov.tw
About this study
Official title: Comparison of Erector Spiane Plan Block (ESPB) Versus Pecto-intercostal Fascial Block(PIFB) for Analgesia and Respiratory Function Recovery in Cardiac Surgery: a Randomized Control Trial
This clinical trial compares analgesia efficiency and recovery outcomes between two different fascial plane block techniques (ESPB vs.PIFB) in cardiac surgery patients participant population/health conditions].
The main questions it aims to answer are:
- Does ESPB provide superior analgesia than PIFB
- Do patients who receive ESPB have better recovery outcomes
Read the detailed description
Regional nerve blocks, including Pecto-intercostal block (PIFB) and Erector spinae plane block (ESPB), can provide a certain level of analgesia for thoracic and cardiac surgeries. This study focuses on patients undergoing their first conventional sternotomy for cardiac surgery. They are randomly assigned to receive either PIFB or ESPB for pain relief. Comparisons are made between the two groups for postoperative 48-hour analgesic medication requirements, static and dynamic postoperative pain scores, improvements in postoperative respiratory function, quality of life index (QoL15), and other clinically relevant prognostic indicators.
- Conditions
- Analgesia
- Being tested
- Erector spinae plane block (ESPB), Pecto-intercostal fascial plane blok (PIFB)
- Keywords
- Erector spinae plane block, Pecto-intercostal plane block, Cardiac surgery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane block (ESPB)Procedure or surgery
Bilateral ESP: 0.5% ropivacaine 0.3 ml per kg (ideal body weight) each side, 30 min before skin excision. After surgery, use pump to deliver an intermittent automatic bolus of 0.3 ml per kg 0.16% ropivacaine every 4 hours each side.
Pecto-intercostal fascial plane blok (PIFB)Procedure or surgery
Bilateral PIFB: 0.5% ropivacaine 0.3 ml per kg (ideal body weight) each side, 30 min before skin excision. After surgery, use pump to deliver an intermittent automatic bolus of 0.3 ml per kg 0.16% ropivacaine every 4 hours each side.
| Study group | Role | What they receive |
|---|---|---|
| Group E | Experimental | Patients who receive erector spinae plane block(ESPB) before cardiac surgery Receives: Procedure: Erector spinae plane block (ESPB) |
| Group P | Active comparator | Patients who receive Pecto-intercostal plane block(PIFB) before cardiac surgery Receives: Procedure: Pecto-intercostal fascial plane blok (PIFB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
48hr opioid consumption
The primary outcome of this study was the total oral morphine equivalent (OME) dose received within 48 hours after surgery. OME was calculated using a conversion toolkit within our hospital's electronic medical record system, which standardizes opioid analgesic doses to oral morphine equivalents according to established guidelines
Measured: Day 2
Secondary outcomes (12)
Postoperative static pain scores-Day 1
Pain score reported by patients when resting
Measured: Day 1
Postoperative static pain scores-Day 2
Pain score reported by patients when resting
Measured: Day 2
Postoperative dynamic pain scores-Day 1
Pain score reported by patients when mobilizing or deep coughing
Measured: Day 1
Postoperative dynamic pain scores-Day 2
Pain score reported by patients when mobilizing or deep coughing
Measured: Day 2
postoperative incentive spirometry volume (ml)-Day 1
daily volume of incentive spirometry
Measured: Day 1
postoperative incentive spirometry volume (ml)-Day 2
daily volume of incentive spirometry
Measured: Day 2
postoperative incentive spirometry volume (ml)-Day 3
daily volume of incentive spirometry
Measured: Day 3
QoL15 (POD3)
quality of life questionnaire (QoL15) at postoperative day 3
Measured: Day 3
Serum cytokine (IL-6, IL-8, IL-10) - baseline
Baseline serum inflammatory cytokine, collected from the arterial line and the central venous line after induction of general anesthesia
Measured: During surgery (at the time the induction phase was completed, patients were under general anesthesia, and both arterial line and central venous line were in place)
Serum cytokine (IL-6, IL-8, IL-10)- aortic declamp
Serum inflammatory cytokines were collected after the aorta was declamped from both the arterial and central venous lines.
Measured: Within 10 min after the aortic declamping
Serum cytokine (IL-6, IL-8, IL-10)- 6hrs after aortic decalmped
Serum inflammatory cytokines were collected 6 hours after the aorta was declamped from both the arterial and central venous lines.
Measured: 6 hours after the aorta was declamped
Serum cytokine (IL-6, IL-8, IL-10)-24 hrs after surgery
Serum levels of inflammatory cytokines were collected 24 hours after surgery from both the arterial and central venous lines.
Measured: 24 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start8 Nov 2024
- 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 AnalgesiaStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Ting Chang, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322810
- Sponsor's protocol ID
- ESP vs. PIFB
- Status last verified
- Feb 2026
- First submitted
- 10 Mar 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Erector Spiane Plan Block (ESPB) Versus Pecto-intercostal Fascial Block(PIFB) for Analgesia and Respiratory Function Recovery in Cardiac Surgery: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06322810
- Acronym / sponsor ID
- ESP vs. PIFB
- Conditions
- Analgesia
- Keywords
- Erector spinae plane block, Pecto-intercostal plane block, Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Mar 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.
This clinical trial compares analgesia efficiency and recovery outcomes between two different fascial plane block techniques (ESPB vs.PIFB) in cardiac surgery patients participant population/health conditions].
The main questions it aims to answer are:
- Does ESPB provide superior analgesia than PIFB
- Do patients who receive ESPB have better recovery outcomes
Detailed description
Regional nerve blocks, including Pecto-intercostal block (PIFB) and Erector spinae plane block (ESPB), can provide a certain level of analgesia for thoracic and cardiac surgeries. This study focuses on patients undergoing their first conventional sternotomy for cardiac surgery. They are randomly assigned to receive either PIFB or ESPB for pain relief. Comparisons are made between the two groups for postoperative 48-hour analgesic medication requirements, static and dynamic postoperative pain scores, improvements in postoperative respiratory function, quality of life index (QoL15), and other clinically relevant prognostic indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group E | Experimental | Procedure: Erector spinae plane block (ESPB)Patients who receive erector spinae plane block(ESPB) before cardiac surgery |
| Group P | Active comparator | Procedure: Pecto-intercostal fascial plane blok (PIFB)Patients who receive Pecto-intercostal plane block(PIFB) before cardiac surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults patients, elective and first-time cardiac surgery patients undergoing traditional sternotomy. Procedures include coronary artery bypass surgery, valve repair or replacement surgery, atrial and ventricular septal defect repair surgery, and other open-heart surgeries.
Key exclusion criteria (1 listed)
- 1. Emergency surgery 2. Anticipated combined major aortic vascular surgery 3. Already admitted to the ICU or on a ventilator before 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 |
|---|---|---|
| Erector spinae plane block (ESPB)Bilateral ESP: 0.5% ropivacaine 0.3 ml per kg (ideal body weight) each side, 30 min before skin excision. After surgery, use pump to deliver an intermittent automatic bolus of 0.3 ml per kg 0.16% ropivacaine every 4 hours each side. | Procedure or surgery | Group E |
| Pecto-intercostal fascial plane blok (PIFB)Bilateral PIFB: 0.5% ropivacaine 0.3 ml per kg (ideal body weight) each side, 30 min before skin excision. After surgery, use pump to deliver an intermittent automatic bolus of 0.3 ml per kg 0.16% ropivacaine every 4 hours each side. | Procedure or surgery | Group P |
Primary outcome
48hr opioid consumption
Time frame: Day 2
The primary outcome of this study was the total oral morphine equivalent (OME) dose received within 48 hours after surgery. OME was calculated using a conversion toolkit within our hospital's electronic medical record system, which standardizes opioid analgesic doses to oral morphine equivalents according to established guidelines
12 secondary outcomes
Postoperative static pain scores-Day 1
Time frame: Day 1
Postoperative static pain scores-Day 2
Time frame: Day 2
Postoperative dynamic pain scores-Day 1
Time frame: Day 1
Postoperative dynamic pain scores-Day 2
Time frame: Day 2
postoperative incentive spirometry volume (ml)-Day 1
Time frame: Day 1
postoperative incentive spirometry volume (ml)-Day 2
Time frame: Day 2
postoperative incentive spirometry volume (ml)-Day 3
Time frame: Day 3
QoL15 (POD3)
Time frame: Day 3
Serum cytokine (IL-6, IL-8, IL-10) - baseline
Time frame: During surgery (at the time the induction phase was completed, patients were under general anesthesia, and both arterial line and central venous line were in place)
Serum cytokine (IL-6, IL-8, IL-10)- aortic declamp
Time frame: Within 10 min after the aortic declamping
Serum cytokine (IL-6, IL-8, IL-10)- 6hrs after aortic decalmped
Time frame: 6 hours after the aorta was declamped
Serum cytokine (IL-6, IL-8, IL-10)-24 hrs after surgery
Time frame: 24 hours after the surgery
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 24 Feb 2026.
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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 Erector spinae plane block (ESPB) and Pecto-intercostal fascial plane blok (PIFB) in people with Analgesia, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 1 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 24 Feb 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 Taiwan. 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 Yi-Ting Chang, Dr. ((+886)4-23592525 ext. 4101, taco@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
48hr opioid consumption (time frame: Day 2). 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 24 Feb 2026.