SternotomyERACS-ESP-SPIPNCT07304635
Comparison of the Postoperative Analgesic Effectiveness of Erector Spinae Plane Block Versus Its Combination With Superficial Parasternal Intercostal Plane Block Within the ERACS Program
A study testing Procedure: Erector Spinae Plane (ESP) Block and Erector Spinae Plane (ESP) Block + Superficial Parasternal Intercostal Plane (SPIP) Block in people with Sternotomy and Postoperative Delirium, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, double-blind, parallel-group clinical trial within the Enhanced Recovery After Cardiac Surgery (ERACS) program compares postoperative analgesic effectiveness of bilateral erector spinae plane (ESP) block versus ESP combined with superficial parasternal intercostal plane (SPIP) block in… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sternotomy, Postoperative Delirium, Postoperative Pain Management
- What is being tested?
- Procedure: Erector Spinae Plane (ESP) Block and Erector Spinae Plane (ESP) Block + Superficial Parasternal Intercostal Plane (SPIP) Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2024to 30 Jul 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective cardiac surgery via median sternotomy under the ERACS protocol
- Age between 18 and 80 years
- ASA physical status II-III
- Body Mass Index (BMI) between 18 and 35 kg/m²
- No cognitive impairment (able to cooperate and follow commands)
- No history of chronic pain or regular analgesic use
- Provided written informed consent after detailed explanation of the study
Who cannot join
- Age < 18 years or > 80 years
- ASA physical status ≥ IV
- Emergency surgery
- Pregnant or breastfeeding women
- Redo coronary artery bypass surgery
- Pre-existing cognitive disorder or psychiatric illness affecting pain or delirium evaluation
Show all 10Show fewer
- Infection or skin lesion at the injection site
- Known allergy or hypersensitivity to local anesthetics (bupivacaine or amide type)
- Chronic pain or opioid use prior to surgery
- Unwillingness to participate or withdrawal of consent at any stage
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Medicine
Ankara, 06230
About this study
Official title: Comparison of Postoperative Analgesic Effectiveness of Erector Spinae Plane Block and Combined With Superficial Parasternal Intercostal Plane Block Within the Enhanced Recovery After Cardiac Surgery (ERACS) Program: A Prospective, Randomized, Double-Blind Study
This prospective, randomized, double-blind, parallel-group clinical trial within the Enhanced Recovery After Cardiac Surgery (ERACS) program compares postoperative analgesic effectiveness of bilateral erector spinae plane (ESP) block versus ESP combined with superficial parasternal intercostal plane (SPIP) block in adult patients undergoing elective cardiac surgery via median sternotomy.
Read the detailed description
Rationale: Effective multimodal, opioid-sparing analgesia is crucial in cardiac surgery to enhance recovery and reduce pulmonary and cognitive complications. Neuraxial techniques (e.g., epidural) carry increased hematoma risk under anticoagulation; hence, fascial plane blocks like ESP and SPIP are safer alternatives.
Methodology: Randomized (ResearchRandomizer.org), 1:1 allocation, opaque sealed envelopes. ESP and SPIP performed under ultrasound guidance at standardized doses and locations.
Blinding: Patients and postoperative evaluators are blinded; block-performing anesthesiologist unblinded but uninvolved in assessment.
Follow-up: 0-72 hours after extubation with predefined time points for VAS, RASS, and Nu-DESC evaluations.
- Being tested
- Procedure: Erector Spinae Plane (ESP) Block, Erector Spinae Plane (ESP) Block + Superficial Parasternal Intercostal Plane (SPIP) Block
- Keywords
- sternotomy, post-sternotomy pain, postoperative pain, postoperative delirium, erector spinae plane blocks, superficial parasternal intercostal plane blocks
- Medical subject headings
- Emergence Delirium, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: Erector Spinae Plane (ESP) BlockProcedure or surgery
A bilateral ultrasound-guided erector spinae plane block will be performed at the T4-T5 vertebral level after induction of general anesthesia.
Using an 80 mm peripheral nerve block needle and an in-plane approach, 30 mL of 0.25% bupivacaine per side will be injected into the fascial plane deep to the erector spinae muscle.
The spread of the local anesthetic will be visualized in real time in a craniocaudal direction.
This technique provides multidermatomal somatic and visceral analgesia (approximately T2-T9).
Erector Spinae Plane (ESP) Block + Superficial Parasternal Intercostal Plane (SPIP) BlockProcedure or surgery
After induction of general anesthesia, patients will receive:
Bilateral ESP block with 20 mL of 0.25% bupivacaine per side, performed as described above at the T5 level, and
Bilateral SPIP block performed at the 4th-5th intercostal spaces, approximately 2-3 cm lateral to the midline, using a linear ultrasound probe.
For the SPIP block, after confirming needle placement with hydrodissection (1-3 mL saline) and negative aspiration, 10 mL of 0.25% bupivacaine per side will be injected between the pectoralis major and external intercostal muscles.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Erector Spinae Plane Block (Group E) | Experimental | After induction of general anesthesia, patients will receive a bilateral ultrasound-guided erector spinae plane block at the T4--T5 vertebral level.
A total of 30 mL of 0.25% bupivacaine per side (prepared as 10 mL saline + 10 mL 0.5% bupivacaine per syringe) will be injected into the deep fascial plane beneath the erector spinae muscle using an 80 mm block needle under aseptic conditions.
The spread of the local anesthetic will be observed in a craniocaudal direction in real time. The procedure will be repeated bilaterally.
All patients will subsequently receive standardized postoperative analgesia with paracetamol 1 g IV every 6 hours; if VAS > 4, tramadol 50 mg IV will be given as rescue analgesia. Receives: Procedure: Procedure: Erector Spinae Plane (ESP) Block |
| Erector Spinae Plane Block + Superficial Parasternal Intercostal Plane Block (Group EP) | Active comparator | Following induction of general anesthesia, patients will receive a bilateral ESP block (same technique as in Group E) with 20 mL of 0.25% bupivacaine per side.
Afterward, a bilateral superficial parasternal intercostal plane block (SPIP) will be performed in the 4th-5th intercostal spaces, approximately 2-3 cm lateral to the midline, using a linear ultrasound probe and 80 mm block needle.
After confirming negative aspiration and hydrodissection with 1-3 mL saline, 10 mL of 0.25% bupivacaine per side will be injected into the interfacial plane.
The total local anesthetic volume for both blocks combined will be 60 mL, kept below the toxic threshold.
Standard postoperative analgesia will be identical to Group E (paracetamol 1 g IV every 6 hours, and tramadol 50 mg IV if VAS > 4). Receives: Procedure: Erector Spinae Plane (ESP) Block + Superficial Parasternal Intercostal Plane (SPIP) Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS (resting)
Average of VAS scores at 0, 1, 6, 12, 24, 48, and 72 hours after extubation (t=0). Lower scores indicate better analgesia.
Pain was assessed using the 0-10 Visual Analog Scale (VAS).
Pain severity was classified as follows:
0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. Rescue analgesia was administered when VAS score was > 4.
Measured: Up to 72 hours post-extubation
Secondary outcomes (5)
VAS (movement)
Mean VAS scores during movement at all time points
Measured: 0-72 hours
Total rescue tramadol use (mg)
Cumulative IV tramadol dose
Measured: 0-72 hours
Time to first rescue analgesic (min)
Time between extubation and first rescue tramadol
Measured: 0-72 hours
Delirium incidence (Nu-DESC ≥ 2)
Nursing Delirium Screening Scale (Nu-DESC) score ≥ 2 Delirium was assessed using the Nursing Delirium Screening Scale (NU-DESC). NU-DESC consists of five items, each scored from 0 to 2 (total score: 0-10). A total NU-DESC score ≥ 2 was considered positive for delirium.
Items:
Disorientation Inappropriate behavior Inappropriate communication Illusions / hallucinations Psychomotor retardation
Measured: 12, 24, 48, 72 hours
RASS score profile
Richmond Agitation-Sedation Scale distribution Sedation level was assessed using the Richmond Agitation-Sedation Scale (RASS).
RASS scores were classified as:
- 4 = combative,
- 3 = very agitated,
- 2 = agitated,
- 1 = restless, 0 = alert and calm,
- 1 = drowsy,
- 2 = light sedation,
- 3 = moderate sedation,
- 4 = deep sedation,
- 5 = unarousable.
Measured: 0, 12, 24, 48, 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start30 Aug 2024
- Primary completion27 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SternotomyStudies of the same condition, open and under way.
- More trials run by Ankara 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 study is designed as a prospective, randomized, double-blind, parallel-group clinical trial conducted within the Enhanced Recovery After Cardiac Surgery (ERACS) program. A total of 42 adult patients undergoing elective cardiac surgery via median sternotomy will be randomized in a 1:1 ratio into two groups using a computer-generated randomization sequence and sealed opaque envelopes. Group E: Bilateral erector spinae plane (ESP) block Group EP: Bilateral ESP block combined with superficial parasternal intercostal plane (SPIP) block Both interventions will be performed under ultrasound guidance after induction of general anesthesia. Postoperative assessments-including VAS pain scores, sedation (RASS), and delirium screening (Nu-DESC)-will be recorded at standardized time points up to 72 hours after extubation. The study aims to compare postoperative analgesic effectiveness and the impact of pain control on postoperative delirium.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FATMA CANDAN YEREBAKAN, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304635
- Sponsor's protocol ID
- ERACSDEL001
- Acronym
- ERACS-ESP-SPIP
- Status last verified
- Oct 2025
- First submitted
- 12 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Effectiveness of Erector Spinae Plane Block and Combined With Superficial Parasternal Intercostal Plane Block Within the Enhanced Recovery After Cardiac Surgery (ERACS) Program: A Prospective, Randomized, Double-Blind Study
- ClinicalTrials.gov ID
- NCT07304635
- Acronym / sponsor ID
- ERACS-ESP-SPIP / ERACSDEL001
- Keywords
- sternotomy, post-sternotomy pain, postoperative pain, postoperative delirium, erector spinae plane blocks, superficial parasternal intercostal plane blocks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 27 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 26 Dec 2025 (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 prospective, randomized, double-blind, parallel-group clinical trial within the Enhanced Recovery After Cardiac Surgery (ERACS) program compares postoperative analgesic effectiveness of bilateral erector spinae plane (ESP) block versus ESP combined with superficial parasternal intercostal plane (SPIP) block in adult patients undergoing elective cardiac surgery via median sternotomy.
Detailed description
Rationale: Effective multimodal, opioid-sparing analgesia is crucial in cardiac surgery to enhance recovery and reduce pulmonary and cognitive complications. Neuraxial techniques (e.g., epidural) carry increased hematoma risk under anticoagulation; hence, fascial plane blocks like ESP and SPIP are safer alternatives.
Methodology: Randomized (ResearchRandomizer.org), 1:1 allocation, opaque sealed envelopes. ESP and SPIP performed under ultrasound guidance at standardized doses and locations.
Blinding: Patients and postoperative evaluators are blinded; block-performing anesthesiologist unblinded but uninvolved in assessment.
Follow-up: 0-72 hours after extubation with predefined time points for VAS, RASS, and Nu-DESC evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study is designed as a prospective, randomized, double-blind, parallel-group clinical trial conducted within the Enhanced Recovery After Cardiac Surgery (ERACS) program. A total of 42 adult patients undergoing elective cardiac surgery via median sternotomy will be randomized in a 1:1 ratio into two groups using a computer-generated randomization sequence and sealed opaque envelopes. Group E: Bilateral erector spinae plane (ESP) block Group EP: Bilateral ESP block combined with superficial parasternal intercostal plane (SPIP) block Both interventions will be performed under ultrasound guidance after induction of general anesthesia. Postoperative assessments-including VAS pain scores, sedation (RASS), and delirium screening (Nu-DESC)-will be recorded at standardized time points up to 72 hours after extubation. The study aims to compare postoperative analgesic effectiveness and the impact of pain control on postoperative delirium.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Erector Spinae Plane Block (Group E) | Experimental | Procedure: Procedure: Erector Spinae Plane (ESP) BlockAfter induction of general anesthesia, patients will receive a bilateral ultrasound-guided erector spinae plane block at the T4--T5 vertebral level. A total of 30 mL of 0.25% bupivacaine per side (prepared as 10 mL saline + 10 mL 0.5% bupivacaine per syringe) will be injected into the deep fascial plane beneath the erector spinae muscle using an 80 mm block needle under aseptic conditions. The spread of the local anesthetic will be observed in a craniocaudal direction in real time. The procedure will be repeated bilaterally. All patients will subsequently receive standardized postoperative analgesia with paracetamol 1 g IV every 6 hours; if VAS > 4, tramadol 50 mg IV will be given as rescue analgesia. |
| Erector Spinae Plane Block + Superficial Parasternal Intercostal Plane Block (Group EP) | Active comparator | Procedure: Erector Spinae Plane (ESP) Block + Superficial Parasternal Intercostal Plane (SPIP) BlockFollowing induction of general anesthesia, patients will receive a bilateral ESP block (same technique as in Group E) with 20 mL of 0.25% bupivacaine per side. Afterward, a bilateral superficial parasternal intercostal plane block (SPIP) will be performed in the 4th-5th intercostal spaces, approximately 2-3 cm lateral to the midline, using a linear ultrasound probe and 80 mm block needle. After confirming negative aspiration and hydrodissection with 1-3 mL saline, 10 mL of 0.25% bupivacaine per side will be injected into the interfacial plane. The total local anesthetic volume for both blocks combined will be 60 mL, kept below the toxic threshold. Standard postoperative analgesia will be identical to Group E (paracetamol 1 g IV every 6 hours, and tramadol 50 mg IV if VAS > 4). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients scheduled for elective cardiac surgery via median sternotomy under the ERACS protocol
- Age between 18 and 80 years
- ASA physical status II-III
- Body Mass Index (BMI) between 18 and 35 kg/m²
- No cognitive impairment (able to cooperate and follow commands)
Key exclusion criteria (10 listed)
- Age < 18 years or > 80 years
- ASA physical status ≥ IV
- Emergency surgery
- Pregnant or breastfeeding women
- Redo coronary artery bypass 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 |
|---|---|---|
| Procedure: Erector Spinae Plane (ESP) BlockA bilateral ultrasound-guided erector spinae plane block will be performed at the T4-T5 vertebral level after induction of general anesthesia. Using an 80 mm peripheral nerve block needle and an in-plane approach, 30 mL of 0.25% bupivacaine per side will be injected into the fascial plane deep to the erector spinae muscle. The spread of the local anesthetic will be visualized in real time in a craniocaudal direction. This technique provides multidermatomal somatic and visceral analgesia (approximately T2-T9). | Procedure or surgery | Arm 1: Erector Spinae Plane Block (Group E) |
| Erector Spinae Plane (ESP) Block + Superficial Parasternal Intercostal Plane (SPIP) BlockAfter induction of general anesthesia, patients will receive: Bilateral ESP block with 20 mL of 0.25% bupivacaine per side, performed as described above at the T5 level, and Bilateral SPIP block performed at the 4th-5th intercostal spaces, approximately 2-3 cm lateral to the midline, using a linear ultrasound probe. For the SPIP block, after confirming needle placement with hydrodissection (1-3 mL saline) and negative aspiration, 10 mL of 0.25% bupivacaine per side will be injected between the pectoralis major and external intercostal muscles. | Procedure or surgery | Erector Spinae Plane Block + Superficial Parasternal Intercostal Plane Block (Group EP) |
Primary outcome
VAS (resting)
Time frame: Up to 72 hours post-extubation
Average of VAS scores at 0, 1, 6, 12, 24, 48, and 72 hours after extubation (t=0). Lower scores indicate better analgesia. Pain was assessed using the 0-10 Visual Analog Scale (VAS). Pain severity was classified as follows: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain. Rescue analgesia was administered when VAS score was > 4.
5 secondary outcomes
VAS (movement)
Time frame: 0-72 hours
Total rescue tramadol use (mg)
Time frame: 0-72 hours
Time to first rescue analgesic (min)
Time frame: 0-72 hours
Delirium incidence (Nu-DESC ≥ 2)
Time frame: 12, 24, 48, 72 hours
RASS score profile
Time frame: 0, 12, 24, 48, 72 hours
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 31 Dec 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: Erector Spinae Plane (ESP) Block and Erector Spinae Plane (ESP) Block + Superficial Parasternal Intercostal Plane (SPIP) Block in people with Sternotomy and Postoperative Delirium, run by Ankara University at 1 site in Turkey (Türkiye).
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 7 inclusion and 10 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 31 Dec 2025. 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 Turkey (Türkiye). 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?
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?
VAS (resting) (time frame: Up to 72 hours post-extubation). 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 31 Dec 2025.