Postoperative PainNCT07315308
Preoperative Deep Parasternal Intercostal Plane Block and Intraoperative Opioid Use in Cardiac Surgery
A study testing Deep Parasternal Intercostal Plane Block and Standard Multimodal Analgesia in people with Postoperative Pain and Sternotomy, run by Gaziantep City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Median sternotomy is commonly used in cardiac surgery and is associated with significant intraoperative and postoperative pain, often requiring substantial opioid administration. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Sternotomy, Opioid Consumption
- What is being tested?
- Deep Parasternal Intercostal Plane Block and Standard Multimodal Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2026to 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years Scheduled to undergo elective cardiac surgery via median sternotomy Planned general anesthesia Able to provide written informed consent
Who cannot join
- Known allergy or contraindication to local anesthetics Coagulation disorders or ongoing anticoagulant therapy that contraindicates regional anesthesia Infection at or near the planned injection site Pre-existing chronic pain conditions requiring long-term opioid use Severe cognitive impairment or inability to communicate pain intensity Emergency surgery Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziantep Sehir Hastanesi
Gaziantep, Sahinbey
About this study
Official title: Preoperative Ultrasound-Guided Deep Parasternal Intercostal Plane Block Reduces Intraoperative Opioid Consumption in Adults Undergoing Cardiac Surgery Via Median Sternotomy
Median sternotomy is commonly used in cardiac surgery and is associated with significant intraoperative and postoperative pain, often requiring substantial opioid administration. High opioid use during cardiac surgery may contribute to adverse effects such as respiratory depression, delayed extubation, postoperative nausea and vomiting, and prolonged intensive care unit stay. Therefore, effective opioid-sparing strategies are an important component of modern perioperative care.
The deep parasternal intercostal plane (DPIP) block is a regional anesthesia technique that targets the anterior cutaneous branches of the intercostal nerves, which are responsible for transmitting pain from the sternum and adjacent tissues. When performed under ultrasound guidance, this block allows precise local anesthetic deposition while minimizing the risk of pleural or vascular injury.
Read more
The purpose of this randomized controlled study is to evaluate whether a preoperative ultrasound-guided DPIP block reduces intraoperative opioid consumption in adult patients undergoing elective cardiac surgery via median sternotomy. Patients will be randomly assigned to receive either a bilateral DPIP block in addition to standard general anesthesia or standard general anesthesia alone.
The primary outcome of the study is total intraoperative opioid consumption. Secondary outcomes include time to extubation, postoperative opioid consumption within the first 24 hours, postoperative pain scores, and the incidence of opioid-related adverse effects. The results of this study may help define the role of the DPIP block as part of a multimodal, opioid-sparing analgesic strategy in cardiac surgery.
Read the detailed description
Adequate pain control during and after cardiac surgery via median sternotomy remains challenging despite advances in perioperative care. Opioids continue to be the mainstay of analgesia; however, excessive intraoperative opioid administration has been associated with delayed extubation, respiratory complications, postoperative nausea and vomiting, and prolonged intensive care unit stay. As part of enhanced recovery protocols, regional anesthesia techniques that provide effective opioid-sparing analgesia are increasingly emphasized.
The deep parasternal intercostal plane (DPIP) block is a relatively novel ultrasound-guided regional anesthesia technique that targets the anterior cutaneous branches of the intercostal nerves within the fascial plane between the internal intercostal and transversus thoracis muscles. Compared with more proximal neuraxial or paravertebral techniques, the DPIP block offers a more localized and anatomically specific approach to sternotomy-related pain while potentially reducing the risk of serious complications.
In this prospective, randomized controlled trial, adult patients scheduled for elective cardiac surgery via median sternotomy will be allocated to one of two parallel groups. Patients in the intervention group will receive a bilateral ultrasound-guided DPIP block performed preoperatively after induction of general anesthesia, in addition to standardized general anesthesia management. Patients in the control group will receive standardized general anesthesia alone, without a regional block. Perioperative anesthetic management, including opioid administration, will follow institutional protocols and will be guided by routine clinical parameters.
The primary objective of the study is to assess the effect of the preoperative DPIP block on total intraoperative opioid consumption. Secondary objectives include evaluation of early recovery parameters such as time to extubation, postoperative opioid requirements within the first 24 hours, postoperative pain intensity, and the occurrence of opioid-related adverse events. Safety outcomes related to the block procedure will also be recorded.
This study is designed to provide clinically relevant data on the role of the DPIP block as part of a multimodal analgesic strategy in cardiac surgery. By focusing on intraoperative opioid consumption and early recovery outcomes, the trial aims to clarify whether preoperative application of this targeted regional technique can contribute to improved perioperative management and opioid-sparing anesthesia in patients undergoing median sternotomy.
- Being tested
- Deep Parasternal Intercostal Plane Block, Standard Multimodal Analgesia
- Keywords
- Deep parasternal intercostal plane block, Parasternal block, Ultrasound-guided regional anesthesia, Sternotomy analgesia, Cardiac surgery pain management, Opioid-sparing analgesia, Multimodal analgesia, Anterior chest wall block, Regional anesthesia in cardiac surgery, Intraoperative Pain, Intraoperative Opioid Consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Parasternal Intercostal Plane BlockProcedure or surgery
Bilateral ultrasound-guided deep parasternal intercostal plane block performed after induction of general anesthesia, with injection of local anesthetic into the fascial plane between the internal intercostal and transversus thoracis muscles for postoperative analgesia.
Standard Multimodal AnalgesiaOther
Standard postoperative multimodal analgesia administered according to institutional cardiac anesthesia protocols, without any regional anesthesia technique.
| Study group | Role | What they receive |
|---|---|---|
| Deep Parasternal Intercostal Plane Block Group | Experimental | Participants in this arm will receive a bilateral ultrasound-guided deep parasternal intercostal plane block following induction of general anesthesia, in addition to standard multimodal perioperative analgesia. The block will be performed in the parasternal region under real-time ultrasound guidance by injection of local anesthetic into the fascial plane between the internal intercostal and transversus thoracis muscles. Receives: Procedure: Deep Parasternal Intercostal Plane Block |
| Standard Analgesia (Control) Group | Active comparator | Participants in this arm will receive standard multimodal perioperative analgesia according to institutional cardiac anesthesia protocols. No regional anesthesia techniques, including parasternal plane blocks, will be performed. Receives: Procedure: Deep Parasternal Intercostal Plane Block; Other: Standard Multimodal Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Intraoperative Opioid Consumption
Total amount of opioids administered intraoperatively, expressed as intravenous fentanyl equivalents (µg), adjusted for body weight (µg/kg), recorded from anesthesia records.
Measured: From induction of general anesthesia until completion of surgery
Secondary outcomes (5)
Intraoperative Hemodynamic Stability
Incidence of intraoperative hemodynamic instability, defined as the need for additional opioid administration or vasoactive support in response to surgical stimulation, recorded from anesthesia records.
Measured: During surgery
Time to Extubation
Time elapsed between the end of surgery and successful tracheal extubation, recorded in minutes.
Measured: From completion of surgery to successful tracheal extubation in the intensive care unit
Postoperative Opioid Consumption
Cumulative amount of opioids administered during the first 24 postoperative hours, expressed as intravenous morphine equivalents (mg), obtained from medical records.
Measured: First 24 hours postoperatively
Time to First Rescue Analgesia
Time elapsed from arrival in the intensive care unit to the administration of the first rescue analgesic medication.
Measured: Up to 24 hours postoperatively
Block-Related Complications
Incidence of complications related to the parasternal intercostal plane block, including but not limited to pneumothorax, vascular puncture, local anesthetic systemic toxicity, and infection.
Measured: Intraoperative period and first 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start12 Feb 2026
- 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.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The intervention group will receive a preoperative bilateral ultrasound-guided deep parasternal intercostal plane block in addition to standardized multimodal analgesia, while the control group will receive standardized multimodal analgesia alone. All participants will undergo elective cardiac surgery via median sternotomy under general anesthesia. Outcomes will be assessed intraoperatively and during the first 24 hours postoperatively.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziantep City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Cemil Balık, Gaziantep City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315308
- Sponsor's protocol ID
- 390
- Status last verified
- Mar 2026
- First submitted
- 18 Dec 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared, as the study is a single-center clinical trial and data sharing was not included in the original study protocol or approved by the institutional ethics committee. De-identified aggregate data will be reported in scientific publications.
Publications
Medeiros HJS, Rodrigue ACLF, Mueller A, Korn E, Sabouri AS. Analgesic efficacy of parasternal intercostal plane block for midline sternotomy in adult cardiac surgery: A systematic review and meta-analysis of randomized controlled trials. J Biol Methods. 2024 Nov 14;12(1):e99010033. doi: 10.14440/jbm.2024.0070. eCollection 2025.
PubMed 40200942Wong HMK, Chen PY, Tang GCC, Chiu SLC, Mok LYH, Au SSW, Wong RHL. Deep Parasternal Intercostal Plane Block for Intraoperative Pain Control in Cardiac Surgical Patients for Sternotomy: A Prospective Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2024 Mar;38(3):683-690. doi: 10.1053/j.jvca.2023.11.038. Epub 2023 Nov 30.
PubMed 38148266Li Q, Liao Y, Wang X, Zhan M, Xiao L, Chen Y. Efficacy of bilateral catheter superficial parasternal intercostal plane blocks using programmed intermittent bolus for opioid-sparing postoperative analgesia in cardiac surgery with sternotomy: A randomized, double-blind, placebo-controlled trial. J Clin Anesth. 2024 Aug;95:111430. doi: 10.1016/j.jclinane.2024.111430. Epub 2024 Mar 26.
PubMed 38537393
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Ultrasound-Guided Deep Parasternal Intercostal Plane Block Reduces Intraoperative Opioid Consumption in Adults Undergoing Cardiac Surgery Via Median Sternotomy
- ClinicalTrials.gov ID
- NCT07315308
- Acronym / sponsor ID
- 390
- Keywords
- Deep parasternal intercostal plane block, Parasternal block, Ultrasound-guided regional anesthesia, Sternotomy analgesia, Cardiac surgery pain management, Opioid-sparing analgesia, Multimodal analgesia, Anterior chest wall block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Gaziantep City HospitalUniversity, hospital or other
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 2 Jan 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.
Median sternotomy is commonly used in cardiac surgery and is associated with significant intraoperative and postoperative pain, often requiring substantial opioid administration. High opioid use during cardiac surgery may contribute to adverse effects such as respiratory depression, delayed extubation, postoperative nausea and vomiting, and prolonged intensive care unit stay. Therefore, effective opioid-sparing strategies are an important component of modern perioperative care.
The deep parasternal intercostal plane (DPIP) block is a regional anesthesia technique that targets the anterior cutaneous branches of the intercostal nerves, which are responsible for transmitting pain from the sternum and adjacent tissues. When performed under ultrasound guidance, this block allows precise local anesthetic deposition while minimizing the risk of pleural or vascular injury.
The purpose of this randomized controlled study is to evaluate whether a preoperative ultrasound-guided DPIP block reduces intraoperative opioid consumption in adult patients undergoing elective cardiac surgery via median sternotomy. Patients will be randomly assigned to receive either a bilateral DPIP block in addition to standard general anesthesia or standard general anesthesia alone.
The primary outcome of the study is total intraoperative opioid consumption. Secondary outcomes include time to extubation, postoperative opioid consumption within the first 24 hours, postoperative pain scores, and the incidence of opioid-related adverse effects. The results of this study may help define the role of the DPIP block as part of a multimodal, opioid-sparing analgesic strategy in cardiac surgery.
Detailed description
Adequate pain control during and after cardiac surgery via median sternotomy remains challenging despite advances in perioperative care. Opioids continue to be the mainstay of analgesia; however, excessive intraoperative opioid administration has been associated with delayed extubation, respiratory complications, postoperative nausea and vomiting, and prolonged intensive care unit stay. As part of enhanced recovery protocols, regional anesthesia techniques that provide effective opioid-sparing analgesia are increasingly emphasized.
The deep parasternal intercostal plane (DPIP) block is a relatively novel ultrasound-guided regional anesthesia technique that targets the anterior cutaneous branches of the intercostal nerves within the fascial plane between the internal intercostal and transversus thoracis muscles. Compared with more proximal neuraxial or paravertebral techniques, the DPIP block offers a more localized and anatomically specific approach to sternotomy-related pain while potentially reducing the risk of serious complications.
In this prospective, randomized controlled trial, adult patients scheduled for elective cardiac surgery via median sternotomy will be allocated to one of two parallel groups. Patients in the intervention group will receive a bilateral ultrasound-guided DPIP block performed preoperatively after induction of general anesthesia, in addition to standardized general anesthesia management. Patients in the control group will receive standardized general anesthesia alone, without a regional block. Perioperative anesthetic management, including opioid administration, will follow institutional protocols and will be guided by routine clinical parameters.
The primary objective of the study is to assess the effect of the preoperative DPIP block on total intraoperative opioid consumption. Secondary objectives include evaluation of early recovery parameters such as time to extubation, postoperative opioid requirements within the first 24 hours, postoperative pain intensity, and the occurrence of opioid-related adverse events. Safety outcomes related to the block procedure will also be recorded.
This study is designed to provide clinically relevant data on the role of the DPIP block as part of a multimodal analgesic strategy in cardiac surgery. By focusing on intraoperative opioid consumption and early recovery outcomes, the trial aims to clarify whether preoperative application of this targeted regional technique can contribute to improved perioperative management and opioid-sparing anesthesia in patients undergoing median sternotomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The intervention group will receive a preoperative bilateral ultrasound-guided deep parasternal intercostal plane block in addition to standardized multimodal analgesia, while the control group will receive standardized multimodal analgesia alone. All participants will undergo elective cardiac surgery via median sternotomy under general anesthesia. Outcomes will be assessed intraoperatively and during the first 24 hours postoperatively.
| Arm | Type | Receives |
|---|---|---|
| Deep Parasternal Intercostal Plane Block Group | Experimental | Procedure: Deep Parasternal Intercostal Plane BlockParticipants in this arm will receive a bilateral ultrasound-guided deep parasternal intercostal plane block following induction of general anesthesia, in addition to standard multimodal perioperative analgesia. The block will be performed in the parasternal region under real-time ultrasound guidance by injection of local anesthetic into the fascial plane between the internal intercostal and transversus thoracis muscles. |
| Standard Analgesia (Control) Group | Active comparator | Procedure: Deep Parasternal Intercostal Plane Block, Other: Standard Multimodal AnalgesiaParticipants in this arm will receive standard multimodal perioperative analgesia according to institutional cardiac anesthesia protocols. No regional anesthesia techniques, including parasternal plane blocks, will be performed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18 to 65 years Scheduled to undergo elective cardiac surgery via median sternotomy Planned general anesthesia Able to provide written informed consent
Key exclusion criteria (1 listed)
- Known allergy or contraindication to local anesthetics Coagulation disorders or ongoing anticoagulant therapy that contraindicates regional anesthesia Infection at or near the planned injection site Pre-existing chronic pain conditions requiring long-term opioid use Severe cognitive impairment or inability to communicate pain intensity Emergency surgery Refusal or inability to provide informed consent
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 |
|---|---|---|
| Deep Parasternal Intercostal Plane BlockBilateral ultrasound-guided deep parasternal intercostal plane block performed after induction of general anesthesia, with injection of local anesthetic into the fascial plane between the internal intercostal and transversus thoracis muscles for postoperative analgesia. | Procedure or surgery | Deep Parasternal Intercostal Plane Block Group, Standard Analgesia (Control) Group |
| Standard Multimodal AnalgesiaStandard postoperative multimodal analgesia administered according to institutional cardiac anesthesia protocols, without any regional anesthesia technique. | Other | Standard Analgesia (Control) Group |
Primary outcome
Total Intraoperative Opioid Consumption
Time frame: From induction of general anesthesia until completion of surgery
Total amount of opioids administered intraoperatively, expressed as intravenous fentanyl equivalents (µg), adjusted for body weight (µg/kg), recorded from anesthesia records.
5 secondary outcomes
Intraoperative Hemodynamic Stability
Time frame: During surgery
Time to Extubation
Time frame: From completion of surgery to successful tracheal extubation in the intensive care unit
Postoperative Opioid Consumption
Time frame: First 24 hours postoperatively
Time to First Rescue Analgesia
Time frame: Up to 24 hours postoperatively
Block-Related Complications
Time frame: Intraoperative period and first 24 postoperative hours
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 4 Mar 2026.
- Background: PubMed 40200942Medeiros HJS, Rodrigue ACLF, Mueller A, Korn E, Sabouri AS. Analgesic efficacy of parasternal intercostal plane block for midline sternotomy in adult cardiac surgery: A systematic review and meta-analysis of randomized controlled trials. J Biol Methods. 2024 Nov 14;12(1):e99010033. doi: 10.14440/jbm.2024.0070. eCollection 2025.
- Background: PubMed 38148266Wong HMK, Chen PY, Tang GCC, Chiu SLC, Mok LYH, Au SSW, Wong RHL. Deep Parasternal Intercostal Plane Block for Intraoperative Pain Control in Cardiac Surgical Patients for Sternotomy: A Prospective Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2024 Mar;38(3):683-690. doi: 10.1053/j.jvca.2023.11.038. Epub 2023 Nov 30.
- Background: PubMed 38537393Li Q, Liao Y, Wang X, Zhan M, Xiao L, Chen Y. Efficacy of bilateral catheter superficial parasternal intercostal plane blocks using programmed intermittent bolus for opioid-sparing postoperative analgesia in cardiac surgery with sternotomy: A randomized, double-blind, placebo-controlled trial. J Clin Anesth. 2024 Aug;95:111430. doi: 10.1016/j.jclinane.2024.111430. Epub 2024 Mar 26.
- Individual participant dataSharing planned: No. Individual participant data will not be shared, as the study is a single-center clinical trial and data sharing was not included in the original study protocol or approved by the institutional ethics committee. De-identified aggregate data will be reported in scientific publications.
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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 Deep Parasternal Intercostal Plane Block and Standard Multimodal Analgesia in people with Postoperative Pain and Sternotomy, run by Gaziantep City Hospital 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 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 4 Mar 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 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?
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 Burak Cemil BALIK, MD (905339545102, cburakbalik@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Intraoperative Opioid Consumption (time frame: From induction of general anesthesia until completion of surgery). 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 NCT07315308, which also lists 3 linked publications.
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 4 Mar 2026.