Postoperative PainNCT07916558
Impact of Parasternal and Rectointercostal Blocks on Extubation Time
An observational study of Postoperative Pain and Extubation Time, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
"Postoperative pain constitutes a major recovery challenge in patients undergoing open-heart surgery with median sternotomy and chest tube insertion (subxiphoid/intercostal). This study aimed to evaluate the effect of parasternal and rectointercostal block administration-performed to achieve pain control and reduce… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain, Extubation Time
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Oct 2026to 10 Nov 2026
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: "Patients who underwent open-heart surgery in our clinic during the period of 2024-2025
Who may be able to join
- Patients undergoing elective CABG or valve surgery
- Patients with median sternotomy and chest tube/drain placement
- Patients with complete anesthesia and intensive care unit follow-up records
Who cannot join
- Patients undergoing emergency surgery or reoperation
- Patients who could not be extubated for more than 24 hours
- Patients with missing medical record or follow-up data
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
Samsun City Hospital
Samsun
mehmet gökhan taflan, 05352114070, drmehmettaflan@gmail.com
About this study
Official title: "The Effect of Ultrasound-Guided Parasternal and Rectointercostal Block Application on Postoperative Extubation Timing in Open Heart Surgery: A 2-Year Retrospective Cohort Study"
"Postoperative pain constitutes a major recovery challenge in patients undergoing open-heart surgery with median sternotomy and chest tube insertion (subxiphoid/intercostal). This study aimed to evaluate the effect of parasternal and rectointercostal block administration-performed to achieve pain control and reduce the postoperative analgesic burden-on patient postoperative recovery and extubation time."
Read the detailed description
"Median sternotomy performed in open-heart surgery causes severe anterior chest wall pain in the postoperative period. This pain leads to inadequate inspiration, suppression of the cough reflex, atelectasis, and increased pulmonary complications. On the other hand, traditionally used high-dose opioid-based analgesia regimens delay the extubation process by causing respiratory depression, nausea, sedation, and impaired intestinal motility.
In current cardiac anesthesia practice, the primary goal is to reduce opioid consumption through multimodal analgesia approaches, enable early extubation (fast-track cardiac anesthesia), and shorten the duration of intensive care unit stay.
Median sternotomy performed in open-heart surgery causes severe anterior chest wall pain in the postoperative period. This pain leads to inadequate inspiration, suppression of the cough reflex, atelectasis, and an increase in pulmonary complications. On the other hand, traditionally used high-dose opioid-based analgesia regimens delay the extubation process by causing respiratory depression, nausea, sedation, and gastrointestinal motility disorders.
In current cardiac anesthesia practice, the primary goal is to reduce opioid consumption through multimodal analgesia approaches, enable early extubation (fast-track cardiac anesthesia), and shorten the length of stay in the intensive care unit.
Parasternal block (parasternal intercostal block or pectoral/parasternal fascial plane blocks) targets the anterior cutaneous branches of T2-T6 spinal nerves, providing potent analgesia around the sternum and internal mammary area. Studies in the literature demonstrate that bilateral parasternal block performed under ultrasonography (USG) guidance significantly controls somatic pain related to sternotomy incision.
Rectointercostal fascial plane block blocks the anterior and lateral cutaneous branches of T6-T9 intercostal nerves. It provides somatic analgesia in the epigastric region, subxiphoid incision lines, and the lower border of the anterior abdominal/chest wall. It specifically blocks the sharp pain at the subxiphoid chest tube (drain) insertion sites-which are not covered by the parasternal block applied for median sternotomy in open-heart surgery-and the discomfort during tube removal.
Opioid Sparing and Pulmonary Functions: Randomized controlled trials have reported that blocks administered intraoperatively or at the end of surgery reduce total postoperative 24-hour opioid (fentanyl, morphine, tramadol) consumption by 30% to 50%. Decreased opioid requirement improves the recovery quality of patients by minimizing systemic side effects.
Extubation Time: Optimization of analgesia ensures the maintenance of patient chest wall compliance and tidal volume. Literature shows that patients receiving blocks reach weaning criteria faster once normothermia and hemodynamic stability are achieved, and their mean extubation times are significantly shorter compared to control groups.
Although prospective studies exist in the literature, retrospective cohort analyses investigating the impact of clinical routine practice on extubation times and reflecting real-world data are needed.
For this purpose, patients who underwent open-heart surgery in our clinic during a 2-year period (2024-2025) will be screened to investigate the effect of block applications on extubation times.
"Patients' age, sex, BMI, presence of comorbidities, ejection fraction, duration of surgery, cardiopulmonary bypass time, cross-clamp time, extubation time, administration of rescue analgesia, Visual Analog Scale (VAS) score at extubation, EuroSCORE II, and length of intensive care unit (ICU) stay will be recorded.
The primary endpoint was determined as meeting the weaning criteria and achieving successful extubation.
The secondary endpoint was determined as discharge from the intensive care unit
- Conditions
- Postoperative Pain, Extubation Time
- Keywords
- open heart surgery, extubation time, thoracic nerve block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NERVE BLOCK GROUP | "Patients who underwent ultrasound-guided parasternal and rectointercostal block for postoperative analgesia. | |
| Standard Analgesia Group | "Patients followed up with routine postoperative analgesics without receiving any nerve block." |
What is being measured
The primary outcome is the main question the study is designed to answer.
POSTOPERATİVE EXTUBATİON TİME
The primary result measure is the extubation period recorded as the time from the patient's arrival at the intensive care unit to successful extubation.
Measured: Within the first 24-48 hours postoperatively
Secondary outcomes (2)
Visual Analog Scale (VAS) Pain Score at 30 Minutes Post-Extubation
"Assessment of postoperative pain intensity using the Visual Analog Scale (ranging from 0 to 10) 30 minutes following tracheal extubation
Measured: postoperative 30th minute
Visual Analog Scale (VAS) Pain Score at 2 Hours Post-Extubation
Assessment of postoperative pain intensity using the Visual Analog Scale (ranging from 0 to 10) 2 hours following tracheal extubation.
Measured: postoperative 2nd hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start26 Oct 2026 (estimated)
- Primary completion2 Nov 2026 (estimated)
- Study completion10 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökçe Özgen, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916558
- Sponsor's protocol ID
- GOKAEK 2026/20/7
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kelava M, Alfirevic A, Bustamante S, Hargrave J, Marciniak D. Regional Anesthesia in Cardiac Surgery: An Overview of Fascial Plane Chest Wall Blocks. Anesth Analg. 2020 Jul;131(1):127-135. doi: 10.1213/ANE.0000000000004682.
PubMed 32032103Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Alver S, Sakul BU, Ansen G, Pence KB, Alici HA. Recto-intercostal fascial plane block: Another novel fascial plane block. J Clin Anesth. 2023 Oct;89:111163. doi: 10.1016/j.jclinane.2023.111163. Epub 2023 Jun 7. No abstract available.
PubMed 37295124Pascarella G, Costa F, Nonnis G, Strumia A, Sarubbi D, Schiavoni L, Di Pumpo A, Mortini L, Grande S, Attanasio A, Gadotti G, De Cassai A, Mattei A, Nenna A, Chello M, Cataldo R, Agro FE, Carassiti M. Ultrasound Guided Parasternal Block for Perioperative Analgesia in Cardiac Surgery: A Prospective Study. J Clin Med. 2023 Mar 6;12(5):2060. doi: 10.3390/jcm12052060.
PubMed 36902846Huang Y, Hong M, Mao Q, Liang D, Liu G, Huang M, Zhong H, Lu Y, Zhong Y, Chen Y. Impact of liposomal bupivacaine parasternal block combined with rectus sheath block on postoperative pain in patients undergoing sternotomy for cardiac surgery: a randomized controlled trial. BMC Anesthesiol. 2026 Jun 17;26(1):533. doi: 10.1186/s12871-026-03903-y.
PubMed 42304225
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effect of Ultrasound-Guided Parasternal and Rectointercostal Block Application on Postoperative Extubation Timing in Open Heart Surgery: A 2-Year Retrospective Cohort Study"
- ClinicalTrials.gov ID
- NCT07916558
- Acronym / sponsor ID
- GOKAEK 2026/20/7
- Conditions
- Postoperative Pain, Extubation Time
- Keywords
- open heart surgery, extubation time, thoracic nerve block
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 26 Oct 2026 (estimated)
- Primary completion
- 2 Nov 2026 (estimated)
- Study completion
- 10 Nov 2026 (estimated)
- First posted
- 4 Nov 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.
"Postoperative pain constitutes a major recovery challenge in patients undergoing open-heart surgery with median sternotomy and chest tube insertion (subxiphoid/intercostal). This study aimed to evaluate the effect of parasternal and rectointercostal block administration-performed to achieve pain control and reduce the postoperative analgesic burden-on patient postoperative recovery and extubation time."
Detailed description
"Median sternotomy performed in open-heart surgery causes severe anterior chest wall pain in the postoperative period. This pain leads to inadequate inspiration, suppression of the cough reflex, atelectasis, and increased pulmonary complications. On the other hand, traditionally used high-dose opioid-based analgesia regimens delay the extubation process by causing respiratory depression, nausea, sedation, and impaired intestinal motility.
In current cardiac anesthesia practice, the primary goal is to reduce opioid consumption through multimodal analgesia approaches, enable early extubation (fast-track cardiac anesthesia), and shorten the duration of intensive care unit stay.
Median sternotomy performed in open-heart surgery causes severe anterior chest wall pain in the postoperative period. This pain leads to inadequate inspiration, suppression of the cough reflex, atelectasis, and an increase in pulmonary complications. On the other hand, traditionally used high-dose opioid-based analgesia regimens delay the extubation process by causing respiratory depression, nausea, sedation, and gastrointestinal motility disorders.
In current cardiac anesthesia practice, the primary goal is to reduce opioid consumption through multimodal analgesia approaches, enable early extubation (fast-track cardiac anesthesia), and shorten the length of stay in the intensive care unit.
Parasternal block (parasternal intercostal block or pectoral/parasternal fascial plane blocks) targets the anterior cutaneous branches of T2-T6 spinal nerves, providing potent analgesia around the sternum and internal mammary area. Studies in the literature demonstrate that bilateral parasternal block performed under ultrasonography (USG) guidance significantly controls somatic pain related to sternotomy incision.
Rectointercostal fascial plane block blocks the anterior and lateral cutaneous branches of T6-T9 intercostal nerves. It provides somatic analgesia in the epigastric region, subxiphoid incision lines, and the lower border of the anterior abdominal/chest wall. It specifically blocks the sharp pain at the subxiphoid chest tube (drain) insertion sites-which are not covered by the parasternal block applied for median sternotomy in open-heart surgery-and the discomfort during tube removal.
Opioid Sparing and Pulmonary Functions: Randomized controlled trials have reported that blocks administered intraoperatively or at the end of surgery reduce total postoperative 24-hour opioid (fentanyl, morphine, tramadol) consumption by 30% to 50%. Decreased opioid requirement improves the recovery quality of patients by minimizing systemic side effects.
Extubation Time: Optimization of analgesia ensures the maintenance of patient chest wall compliance and tidal volume. Literature shows that patients receiving blocks reach weaning criteria faster once normothermia and hemodynamic stability are achieved, and their mean extubation times are significantly shorter compared to control groups.
Although prospective studies exist in the literature, retrospective cohort analyses investigating the impact of clinical routine practice on extubation times and reflecting real-world data are needed.
For this purpose, patients who underwent open-heart surgery in our clinic during a 2-year period (2024-2025) will be screened to investigate the effect of block applications on extubation times.
"Patients' age, sex, BMI, presence of comorbidities, ejection fraction, duration of surgery, cardiopulmonary bypass time, cross-clamp time, extubation time, administration of rescue analgesia, Visual Analog Scale (VAS) score at extubation, EuroSCORE II, and length of intensive care unit (ICU) stay will be recorded.
The primary endpoint was determined as meeting the weaning criteria and achieving successful extubation.
The secondary endpoint was determined as discharge from the intensive care unit
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NERVE BLOCK GROUP | – | –"Patients who underwent ultrasound-guided parasternal and rectointercostal block for postoperative analgesia. |
| Standard Analgesia Group | – | –"Patients followed up with routine postoperative analgesics without receiving any nerve block." |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- "Patients who underwent open-heart surgery in our clinic during the period of 2024-2025
Key inclusion criteria (3 listed)
- Patients undergoing elective CABG or valve surgery
- Patients with median sternotomy and chest tube/drain placement
- Patients with complete anesthesia and intensive care unit follow-up records
Key exclusion criteria (3 listed)
- Patients undergoing emergency surgery or reoperation
- Patients who could not be extubated for more than 24 hours
- Patients with missing medical record or follow-up data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
POSTOPERATİVE EXTUBATİON TİME
Time frame: Within the first 24-48 hours postoperatively
The primary result measure is the extubation period recorded as the time from the patient's arrival at the intensive care unit to successful extubation.
2 secondary outcomes
Visual Analog Scale (VAS) Pain Score at 30 Minutes Post-Extubation
Time frame: postoperative 30th minute
Visual Analog Scale (VAS) Pain Score at 2 Hours Post-Extubation
Time frame: postoperative 2nd hour
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 Nov 2026.
- Background: PubMed 32032103Kelava M, Alfirevic A, Bustamante S, Hargrave J, Marciniak D. Regional Anesthesia in Cardiac Surgery: An Overview of Fascial Plane Chest Wall Blocks. Anesth Analg. 2020 Jul;131(1):127-135. doi: 10.1213/ANE.0000000000004682.
- Background: PubMed 37295124Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Alver S, Sakul BU, Ansen G, Pence KB, Alici HA. Recto-intercostal fascial plane block: Another novel fascial plane block. J Clin Anesth. 2023 Oct;89:111163. doi: 10.1016/j.jclinane.2023.111163. Epub 2023 Jun 7. No abstract available.
- Background: PubMed 36902846Pascarella G, Costa F, Nonnis G, Strumia A, Sarubbi D, Schiavoni L, Di Pumpo A, Mortini L, Grande S, Attanasio A, Gadotti G, De Cassai A, Mattei A, Nenna A, Chello M, Cataldo R, Agro FE, Carassiti M. Ultrasound Guided Parasternal Block for Perioperative Analgesia in Cardiac Surgery: A Prospective Study. J Clin Med. 2023 Mar 6;12(5):2060. doi: 10.3390/jcm12052060.
- Background: PubMed 42304225Huang Y, Hong M, Mao Q, Liang D, Liu G, Huang M, Zhong H, Lu Y, Zhong Y, Chen Y. Impact of liposomal bupivacaine parasternal block combined with rectus sheath block on postoperative pain in patients undergoing sternotomy for cardiac surgery: a randomized controlled trial. BMC Anesthesiol. 2026 Jun 17;26(1):533. doi: 10.1186/s12871-026-03903-y.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Postoperative Pain and Extubation Time, run by Samsun 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 3 inclusion and 3 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 4 Nov 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 GÖKÇE ÜLTAN ÖZGEN (05067750245, gokceozgen55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POSTOPERATİVE EXTUBATİON TİME (time frame: Within the first 24-48 hours postoperatively). 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 NCT07916558, which also lists 4 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 Nov 2026.