Chronic Postoperative PainPINB-CPSPNCT07818512
Parasternal Intercostal Nerve Block and Chronic Pain After Cardiac Surgery
A study testing Ultrasound-Guided Parasternal Intercostal Nerve Block and Bupivacaine 0.25% in people with Chronic Postoperative Pain and Chronic Post-Sternotomy Pain, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital.
Trial summary
Chronic post-sternotomy pain is a common but under-recognised complication of cardiac surgery, reported in roughly 11 to 56 percent of patients and capable of persisting for years after the operation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Postoperative Pain, Chronic Post-Sternotomy Pain, CABG
- What is being tested?
- Ultrasound-Guided Parasternal Intercostal Nerve Block and Bupivacaine 0.25%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 28 Sep 2026to 25 Aug 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years
- Scheduled for elective cardiac surgery via median sternotomy
- Able to understand and use the Numeric Rating Scale for pain
- Willing to participate and able to provide written informed consent
Who cannot join
- Surgery planned by a minimally invasive or thoracoscopic approach
- Refusal to participate
- Known allergy to the local anaesthetics or analgesics to be used
- Chronic opioid use
- Coagulopathy
- Infection at the planned block site
Show all 9Show fewer
- Pregnancy or lactation
- Inability to communicate or to score pain reliably
- Psychiatric or neurological condition preventing reliable completion of the BPI-SF and NRS assessments
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Ultrasound-Guided Preemptive Parasternal Intercostal Nerve Block on the Incidence of Chronic Pain After Cardiac Surgery Via Sternotomy: A Prospective Randomized Controlled Trial
Chronic post-sternotomy pain is a common but under-recognised complication of cardiac surgery, reported in roughly 11 to 56 percent of patients and capable of persisting for years after the operation. Effective control of pain in the early postoperative period is thought to reduce the central sensitisation that drives the transition from acute to chronic pain.
This single-centre, prospective, randomised, patient- and assessor-blinded controlled trial investigates whether an ultrasound-guided bilateral parasternal intercostal nerve block, performed preemptively after induction of general anaesthesia and before surgical incision, reduces the incidence of chronic pain three months after cardiac surgery performed through a median sternotomy.
A total of 132 adults scheduled for elective cardiac surgery will be randomised in a 1:1 ratio to receive either the block plus the institution's standard multimodal analgesia protocol, or the standard protocol alone. The primary endpoint is the incidence of chronic post-sternotomy pain at three months, assessed with the Turkish version of the Brief Pain Inventory - Short Form. Secondary endpoints cover acute pain scores, opioid consumption, postoperative nausea and vomiting, and complications.
Read the detailed description
Design and setting. The trial will be conducted in the Department of Anesthesiology and Reanimation, University of Health Sciences Istanbul Bakirkoy Dr. Sadi Konuk Training and Research Hospital. Eligible patients will be identified at the preoperative anaesthesia assessment and written informed consent will be obtained.
Randomisation and blinding. Participants will be allocated 1:1 using sequentially numbered, opaque, sealed envelopes prepared in advance. Patients and the investigator performing postoperative assessments will be unaware of group assignment; the anaesthesiologist performing the block cannot be blinded.
Intervention. In the block group, after induction of general anaesthesia and before surgical incision, a bilateral parasternal intercostal nerve block will be performed in the supine position with a high-frequency linear ultrasound probe (6-15 MHz) and a 22 G, 80 mm echogenic block needle.
Anaesthetic and analgesic management, identical in both groups.
Assessments. Pain is scored with the Numeric Rating Scale at rest and on movement at 0, 3, 6, 12, 18 and 24 hours after extubation. Opioid consumption, postoperative nausea and vomiting and any complications are recorded. At three months patients are contacted by telephone and assessed with the Brief Pain Inventory - Short Form, validated in Turkish by Ataman and colleagues.
Sample size. The calculation is based on the primary endpoint. 66 participants per group will be enrolled, for a total of 132.
- Being tested
- Ultrasound-Guided Parasternal Intercostal Nerve Block, Bupivacaine 0.25%
- Keywords
- parasternal intercostal nerve block, PINB, chronic post-sternotomy pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Parasternal Intercostal Nerve BlockProcedure or surgery
Performed in the supine position after induction of general anaesthesia and before surgical incision, using a 6-15 MHz linear ultrasound probe and a 22 G, 80 mm echogenic block needle.
Bupivacaine 0.25%Drug
0.25 percent bupivacaine administered bilaterally as a single preemptive dose for the parasternal intercostal nerve block.
| Study group | Role | What they receive |
|---|---|---|
| PINB Group | Experimental | After induction of general anaesthesia and before surgical incision, participants receive an ultrasound-guided bilateral parasternal intercostal nerve block, in addition to the institutional standard perioperative analgesia protocol. Receives: Procedure: Ultrasound-Guided Parasternal Intercostal Nerve Block; Drug: Bupivacaine 0.25% |
| Control Group | No intervention | No regional block is performed. Participants receive only the institutional standard perioperative multimodal analgesia protocol, identical to that given to the block group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of chronic post-sternotomy pain at three months
Measured: 3 months after surgery
Incidence of chronic post-sternotomy pain at three months
Proportion of participants reporting pain in the sternotomy region three months after surgery, assessed by telephone with the Turkish Brief Pain Inventory - Short Form (BPI-SF). Chronic pain is defined as a reported pain score above 0 on the 0-10 numeric scale, at rest or on movement, persisting for more than three months after the operation.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start28 Sep 2026 (estimated)
- Primary completion25 Nov 2027 (estimated)
- Study completion25 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups in a 1:1 ratio: preemptive ultrasound-guided bilateral parasternal intercostal nerve block plus standard analgesia, versus standard analgesia alone.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İlayda Kalyoncu Karahan, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818512
- Sponsor's protocol ID
- 2026/310
- Other IDs
- 2026-18-08
- Acronym
- PINB-CPSP
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kleiman AM, Sanders DT, Nemergut EC, Huffmyer JL. Chronic Poststernotomy Pain: Incidence, Risk Factors, Treatment, Prevention, and the Anesthesiologist's Role. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):698-708. doi: 10.1097/AAP.0000000000000663.
PubMed 28937533
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound-Guided Preemptive Parasternal Intercostal Nerve Block on the Incidence of Chronic Pain After Cardiac Surgery Via Sternotomy: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07818512
- Acronym / sponsor ID
- PINB-CPSP / 2026/310
- Keywords
- parasternal intercostal nerve block, PINB, chronic post-sternotomy pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 28 Sep 2026 (estimated)
- Primary completion
- 25 Nov 2027 (estimated)
- Study completion
- 25 Aug 2028 (estimated)
- First posted
- 14 Sep 2026 (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.
Chronic post-sternotomy pain is a common but under-recognised complication of cardiac surgery, reported in roughly 11 to 56 percent of patients and capable of persisting for years after the operation. Effective control of pain in the early postoperative period is thought to reduce the central sensitisation that drives the transition from acute to chronic pain.
This single-centre, prospective, randomised, patient- and assessor-blinded controlled trial investigates whether an ultrasound-guided bilateral parasternal intercostal nerve block, performed preemptively after induction of general anaesthesia and before surgical incision, reduces the incidence of chronic pain three months after cardiac surgery performed through a median sternotomy.
A total of 132 adults scheduled for elective cardiac surgery will be randomised in a 1:1 ratio to receive either the block plus the institution's standard multimodal analgesia protocol, or the standard protocol alone. The primary endpoint is the incidence of chronic post-sternotomy pain at three months, assessed with the Turkish version of the Brief Pain Inventory - Short Form. Secondary endpoints cover acute pain scores, opioid consumption, postoperative nausea and vomiting, and complications.
Detailed description
Design and setting. The trial will be conducted in the Department of Anesthesiology and Reanimation, University of Health Sciences Istanbul Bakirkoy Dr. Sadi Konuk Training and Research Hospital. Eligible patients will be identified at the preoperative anaesthesia assessment and written informed consent will be obtained.
Randomisation and blinding. Participants will be allocated 1:1 using sequentially numbered, opaque, sealed envelopes prepared in advance. Patients and the investigator performing postoperative assessments will be unaware of group assignment; the anaesthesiologist performing the block cannot be blinded.
Intervention. In the block group, after induction of general anaesthesia and before surgical incision, a bilateral parasternal intercostal nerve block will be performed in the supine position with a high-frequency linear ultrasound probe (6-15 MHz) and a 22 G, 80 mm echogenic block needle.
Anaesthetic and analgesic management, identical in both groups.
Assessments. Pain is scored with the Numeric Rating Scale at rest and on movement at 0, 3, 6, 12, 18 and 24 hours after extubation. Opioid consumption, postoperative nausea and vomiting and any complications are recorded. At three months patients are contacted by telephone and assessed with the Brief Pain Inventory - Short Form, validated in Turkish by Ataman and colleagues.
Sample size. The calculation is based on the primary endpoint. 66 participants per group will be enrolled, for a total of 132.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel groups in a 1:1 ratio: preemptive ultrasound-guided bilateral parasternal intercostal nerve block plus standard analgesia, versus standard analgesia alone.
| Arm | Type | Receives |
|---|---|---|
| PINB Group | Experimental | Procedure: Ultrasound-Guided Parasternal Intercostal Nerve Block, Drug: Bupivacaine 0.25%After induction of general anaesthesia and before surgical incision, participants receive an ultrasound-guided bilateral parasternal intercostal nerve block, in addition to the institutional standard perioperative analgesia protocol. |
| Control Group | No intervention | –No regional block is performed. Participants receive only the institutional standard perioperative multimodal analgesia protocol, identical to that given to the block group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 75 years
Key exclusion criteria (9 listed)
- Surgery planned by a minimally invasive or thoracoscopic approach
- Refusal to participate
- Known allergy to the local anaesthetics or analgesics to be used
- Chronic opioid use
- Coagulopathy
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 |
|---|---|---|
| Ultrasound-Guided Parasternal Intercostal Nerve BlockPerformed in the supine position after induction of general anaesthesia and before surgical incision, using a 6-15 MHz linear ultrasound probe and a 22 G, 80 mm echogenic block needle. | Procedure or surgery | PINB Group |
| Bupivacaine 0.25%0.25 percent bupivacaine administered bilaterally as a single preemptive dose for the parasternal intercostal nerve block. | Drug | PINB Group |
Primary outcome
Incidence of chronic post-sternotomy pain at three months
Time frame: 3 months after surgery
Incidence of chronic post-sternotomy pain at three months
Time frame: 3 months after surgery
Proportion of participants reporting pain in the sternotomy region three months after surgery, assessed by telephone with the Turkish Brief Pain Inventory - Short Form (BPI-SF). Chronic pain is defined as a reported pain score above 0 on the 0-10 numeric scale, at rest or on movement, persisting for more than three months after the operation.
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 30 Sep 2026.
- Background: PubMed 28937533Kleiman AM, Sanders DT, Nemergut EC, Huffmyer JL. Chronic Poststernotomy Pain: Incidence, Risk Factors, Treatment, Prevention, and the Anesthesiologist's Role. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):698-708. doi: 10.1097/AAP.0000000000000663.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Parasternal Intercostal Nerve Block and Bupivacaine 0.25% in people with Chronic Postoperative Pain and Chronic Post-Sternotomy Pain, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital.
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 9 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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Ilayda Kalyoncu Karahan, MD (00905325105014, ilaydaakalyoncu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of chronic post-sternotomy pain at three months (time frame: 3 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07818512, which also lists 1 linked publication.
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 30 Sep 2026.