AzTrials
AzTrials

Postoperative PainSPARE-CABGNCT07498946

Comparison of Paravertebral Block and Deep Parasternal Intercostal Plane Block in Cardiac Surgery

A study testing Thoracic paravertebral block (TPVB) and Bilateral Deep Parasternal Intercostal Plane Block in people with Postoperative Pain and Cardiac Surgery, run by Gaziantep City Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Median sternotomy is commonly used in cardiac surgery and is often associated with significant postoperative pain. Poor pain control after sternotomy may increase opioid use, delay mobilization, prolong extubation time, and contribute to respiratory complications and longer hospital stay. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Thoracic paravertebral block (TPVB) and Bilateral Deep Parasternal Intercostal Plane Block
Type of treatment
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
18 Apr 2026to 18 Apr 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

  • Age 18 to 65 years Scheduled for elective cardiac surgery via median sternotomy American Society of Anesthesiologists physical status II or III Planned to undergo surgery under general anesthesia Able to comply with postoperative pain assessment using the Visual Analog Scale Able to provide written informed consent

Who cannot join

  • Emergency cardiac surgery Cardiac surgery performed through an approach other than median sternotomy Redo sternotomy Local infection or skin disruption at the planned block site Known allergy or hypersensitivity to amide local anesthetics Clinically significant coagulopathy or antiplatelet/anticoagulant treatment preventing safe regional block according to institutional protocol Clinically unstable condition or high risk for pleural complications that would make the block unsafe Chronic opioid use or chronic pain syndrome Advanced musculoskeletal disease or deformity that may interfere with pain assessment Neurological or psychiatric disorder causing inability to comply with postoperative pain assessment Cognitive impairment preventing reliable pain assessment Clinically significant peripheral neuropathy or other neurosensory condition affecting pain perception Pregnancy or breastfeeding Severe pulmonary disease, including advanced chronic obstructive pulmonary disease or severe restrictive lung disease Anticipated inability to comply with the study protocol

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Burak Cemil BALIK, MD contact

05339545102

cburakbalik@hotmail.com

Turkey (Türkiye)1 site
  • Gaziantep Şehir Hastanesi

    Gaziantep, Sahinbey

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Ultrasound-Guided Thoracic Paravertebral Block and Bilateral Deep Parasternal Intercostal Plane Block in Adult Patients Undergoing Elective Cardiac Surgery Via Median Sternotomy: A Prospective Randomized Controlled Trial

Median sternotomy is commonly used in cardiac surgery and is often associated with significant postoperative pain. Poor pain control after sternotomy may increase opioid use, delay mobilization, prolong extubation time, and contribute to respiratory complications and longer hospital stay. Regional analgesia techniques may help improve pain management and reduce opioid requirements after surgery.

This study is a prospective, randomized, single-center clinical trial that will compare two ultrasound-guided regional analgesia techniques in adult patients undergoing elective cardiac surgery through median sternotomy: thoracic paravertebral block and bilateral deep parasternal intercostal plane block. A total of 80 patients will be randomly assigned in a 1:1 ratio to receive one of these two blocks in addition to standard general anesthesia and routine multimodal analgesia.

Read more

The main objective of the study is to compare the effects of these two techniques on total opioid consumption during the first 24 hours after surgery. Secondary outcomes include postoperative pain scores, need for additional analgesics, analgesia-related side effects such as nausea, vomiting, or respiratory depression, and extubation time. Pain will be assessed using a visual analog scale at predefined time points during the first 24 postoperative hours.

The study hypothesis is that there will be a clinically meaningful difference in postoperative analgesic effectiveness between thoracic paravertebral block and bilateral deep parasternal intercostal plane block in patients undergoing cardiac surgery via median sternotomy. The results of this study may help guide the selection of the most appropriate regional analgesia technique for pain control after sternotomy.

Read the detailed description

Median sternotomy remains the most commonly used surgical approach in adult cardiac surgery and is associated with substantial postoperative pain. Inadequate pain control after sternotomy may lead to increased opioid consumption, delayed mobilization, prolonged extubation time, respiratory complications, and extended intensive care unit or hospital stay. Despite the routine use of multimodal analgesia, postoperative pain after sternotomy continues to be a significant clinical problem.

Ultrasound-guided regional analgesia techniques have increasingly been used as part of multimodal pain management strategies in cardiac surgery. Thoracic paravertebral block is one of the established regional techniques that can provide effective hemithoracic analgesia. However, its use may be limited by technical difficulty, dependence on operator experience, and the potential risk of complications. In contrast, deep parasternal intercostal plane block is a more superficial fascial plane block that targets the anterior cutaneous branches of the intercostal nerves, which play an important role in sternotomy-related pain. Although both techniques have shown potential benefit in previous studies, direct comparative data between thoracic paravertebral block and deep parasternal intercostal plane block are limited.

This study is designed as a prospective, randomized, controlled, single-center clinical trial in adult patients undergoing elective cardiac surgery via median sternotomy. A total of 80 patients aged 18 to 65 years with American Society of Anesthesiologists physical status II-III will be enrolled. Eligible participants who provide written informed consent will be randomly assigned in a 1:1 ratio to one of two groups: the thoracic paravertebral block group or the bilateral deep parasternal intercostal plane block group. Randomization will be performed using a computer-generated sequence, and group assignments will be concealed in sealed, opaque, sequentially numbered envelopes.

All patients will undergo surgery under standard general anesthesia and routine perioperative monitoring according to institutional practice. In addition to standard anesthesia and multimodal analgesia, patients in one group will receive ultrasound-guided thoracic paravertebral block, while patients in the other group will receive ultrasound-guided bilateral deep parasternal intercostal plane block before surgery. All block procedures will be performed by an experienced anesthesiologist. Surgical procedures will be carried out by the same cardiovascular surgical team using the standard median sternotomy technique in order to reduce procedural variability.

The primary outcome measure is total opioid consumption during the first 24 hours after surgery. Secondary outcome measures include postoperative pain scores assessed with the Visual Analog Scale at 0, 2, 4, 6, 12, and 24 hours, additional analgesic requirements, analgesia-related adverse effects such as nausea, vomiting, or respiratory depression, and extubation time. Demographic and clinical variables including age, sex, body mass index, ASA class, diabetes mellitus, comorbidities, internal mammary artery preparation, and duration of surgery will also be recorded.

The hypothesis of the study is that there will be a significant difference in postoperative analgesic effectiveness between thoracic paravertebral block and bilateral deep parasternal intercostal plane block in adult patients undergoing cardiac surgery through median sternotomy. The findings are expected to contribute to the evidence base regarding the comparative effectiveness and clinical applicability of these two active regional analgesia techniques in post-sternotomy pain management.

Being tested
Thoracic paravertebral block (TPVB), Bilateral Deep Parasternal Intercostal Plane Block
Keywords
Postoperative Pain, Cardiac Surgery, Median Sternotomy, Thoracic Paravertebral Block, Deep Parasternal Intercostal Plane Block, Regional Analgesia, Ultrasound-Guided Nerve Block, Opioid Consumption, Visual Analog Scale
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thoracic paravertebral block (TPVB)Procedure or surgery

    Ultrasound-guided thoracic paravertebral block performed before elective cardiac surgery via median sternotomy, in addition to standard general anesthesia and routine multimodal analgesia.

  • Bilateral Deep Parasternal Intercostal Plane BlockProcedure or surgery

    Ultrasound-guided bilateral deep parasternal intercostal plane block performed before elective cardiac surgery via median sternotomy, in addition to standard general anesthesia and routine multimodal analgesia.

Study groups in NCT07498946
Study groupRoleWhat they receive
Thoracic Paravertebral Block GroupActive comparatorParticipants undergoing elective cardiac surgery via median sternotomy will receive ultrasound-guided thoracic paravertebral block before surgery in addition to standard general anesthesia and routine multimodal analgesia.
Receives: Procedure: Thoracic paravertebral block (TPVB)
Bilateral Deep Parasternal Intercostal Plane Block GroupActive comparatorParticipants undergoing elective cardiac surgery via median sternotomy will receive ultrasound-guided bilateral deep parasternal intercostal plane block before surgery in addition to standard general anesthesia and routine multimodal analgesia.
Receives: Procedure: Bilateral Deep Parasternal Intercostal Plane Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Opioid Consumption in the First 24 Hours After Surgery

    Total opioid consumption during the first 24 postoperative hours will be recorded and compared between the two groups.

    Measured: First 24 hours after surgery

Secondary outcomes (4)
  1. Postoperative Pain Scores Assessed by Visual Analog Scale

    Postoperative pain intensity will be assessed using the Visual Analog Scale at predefined postoperative time points and compared between groups.

    Measured: 0, 2, 4, 6, 12, and 24 hours after surgery

  2. Additional Analgesic Requirement

    The need for rescue or additional analgesic medication during the first 24 postoperative hours will be recorded and compared between groups.

    Measured: First 24 hours after surgery

  3. Analgesia-Related Adverse Effects

    Analgesia-related adverse effects, including nausea, vomiting, and respiratory depression, will be recorded and compared between groups.

    Measured: First 24 hours after surgery

  4. Extubation Time

    Time from the end of surgery to extubation will be recorded and compared between groups.

    Measured: During the postoperative period, up to 24 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start18 Apr 2026 (estimated)
  3. Primary completion18 Apr 2027 (estimated)
  4. Study completion18 Apr 2027 (estimated)

Resources

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
Participants will be randomized in a 1:1 ratio to 2 parallel groups receiving either thoracic paravertebral block or bilateral deep parasternal intercostal plane block.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07498946
Sponsor's protocol ID
371
Acronym
SPARE-CABG
Status last verified
Mar 2026
First submitted
23 Mar 2026
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make individual participant data available to other researchers. Due to patient privacy considerations and institutional data protection policies, individual-level data will not be shared outside the study team.

Publications

  • Li 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
  • Wong 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 38148266

Questions about this trial

What is this clinical trial studying?

A study testing Thoracic paravertebral block (TPVB) and Bilateral Deep Parasternal Intercostal Plane Block in people with Postoperative Pain and Cardiac Surgery, 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: opening soon, as of the sponsor's last update on 27 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 (05339545102, cburakbalik@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Opioid Consumption in the First 24 Hours After Surgery (time frame: First 24 hours after 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 NCT07498946, which also lists 2 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 27 Mar 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
SPARE-CABG Clinical Trial NCT07498946 | AzTrials