Postoperative PainNCT07716943
ASPB-PIPB Combination in Cardiac Surgery
A study testing Combined ASPB and PIPB and Anterior Serratus Plane Block in people with Postoperative Pain and Cardiac Surgery, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Cardiopulmonary bypass surgery is associated with significant postoperative pain, which may adversely affect respiratory function, delay mobilization, prolong hospital stay, and increase postoperative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Cardiac Surgery, Cardiopulmonary Bypass
- What is being tested?
- Combined ASPB and PIPB and Anterior Serratus Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 30 Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing open heart surgery via median sternotomy by the Cardiovascular Surgery Clinic
- Patients over 18 years of age
- ASA II-III patients
Who cannot join
- - Patients undergoing emergency or recurrent surgery
- Patients with left ventricular ejection fraction < 30
- Patients who died per-operatively
- Patients who do not provide informed consent
- Presence of chronic pain
- Presence of allergy to local anesthetics
Show all 11Show fewer
- Presence of infection in the area where the block will be performed
- Coagulopathy
- Pre-existing neurological deficit
- Mental retardation
- Anatomical deformity
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
Sisli etfal research and training hospital
Istanbul, 34371
MUSTAFA ALTINAY, 05333914422, m_altinay@yahoo.com
About this study
Official title: Effects of Combined Anterior Serratus Plane and Pectoral-Intercostal Plane Blocks on Perioperative Analgesia and Enhanced Recovery After Surgery in Cardiopulmonary Bypass Surgery
Cardiopulmonary bypass surgery is associated with significant postoperative pain, which may adversely affect respiratory function, delay mobilization, prolong hospital stay, and increase postoperative complications. Within Enhanced Recovery After Surgery (ERAS) protocols, multimodal analgesia and opioid-sparing strategies have become essential components of perioperative care. Ultrasound-guided fascial plane blocks, including the anterior serratus plane block (ASPB) and pectoral-intercostal plane block (PIPB), have emerged as effective and safe regional anesthesia techniques for cardiac surgery, targeting different sensory innervation of the thoracic wall. However, evidence regarding the combined use of these two blocks remains limited. This study aimed to evaluate whether the combination of ASPB and PIPB improves intraoperative and postoperative analgesia, reduces opioid consumption, and enhances postoperative recovery and ERAS outcomes compared with standard analgesic management in patients undergoing cardiopulmonary bypass surgery.
Read the detailed description
Cardiac surgery performed with cardiopulmonary bypass (CPB) is associated with substantial perioperative nociceptive stimulation originating from median sternotomy, chest tube placement, internal mammary artery harvesting, and extensive mediastinal tissue manipulation. Despite advances in surgical techniques and perioperative care, postoperative pain remains a major challenge following cardiac surgery. Inadequately controlled pain contributes to impaired respiratory mechanics, ineffective coughing, reduced pulmonary function, delayed mobilization, prolonged intensive care unit (ICU) and hospital stay, and an increased incidence of postoperative pulmonary complications. Furthermore, excessive perioperative opioid administration may lead to respiratory depression, postoperative nausea and vomiting, ileus, delirium, and delayed recovery, highlighting the need for effective opioid-sparing analgesic strategies.
Enhanced Recovery After Surgery (ERAS) protocols have increasingly been adopted in cardiac surgery with the aim of reducing perioperative stress, minimizing complications, and accelerating functional recovery. Contemporary ERAS guidelines emphasize multimodal analgesia as a cornerstone of perioperative management, integrating regional anesthesia techniques with non-opioid systemic analgesics to reduce opioid consumption while improving pain control. Ultrasound-guided fascial plane blocks have gained considerable popularity because they are technically straightforward, provide effective thoracic analgesia, and have a favorable safety profile compared with neuraxial techniques in anticoagulated cardiac surgical patients. Among these techniques, the anterior serratus plane block (ASPB) effectively anesthetizes the lateral thoracic wall by blocking the lateral cutaneous branches of the intercostal nerves, whereas the pectoral-intercostal plane block (PIPB) primarily targets the anterior cutaneous branches responsible for pain arising from median sternotomy. Given their complementary anatomical distributions, combining ASPB and PIPB may provide more comprehensive analgesic coverage of both the anterior and lateral thoracic walls.
Although both ASPB and PIPB have individually demonstrated promising analgesic efficacy in cardiac surgery, evidence regarding the combined use of these two fascial plane blocks remains limited. Whether the addition of ASPB to PIPB results in superior perioperative analgesia, reduced opioid requirements, improved postoperative recovery, and enhanced compliance with ERAS pathways has not yet been clearly established. Therefore, the present study aimed to compare the effects of combined anterior serratus plane block and pectoral-intercostal plane block with standard analgesic management on intraoperative opioid consumption, postoperative pain scores, postoperative analgesic requirements, recovery parameters, and ERAS-related outcomes in patients undergoing cardiopulmonary bypass surgery.
- Being tested
- Combined ASPB and PIPB, Anterior Serratus Plane Block
- Keywords
- Cardiopulmonary Bypass, Postoperative Pain, Regional Anesthesia, Enhanced Recovery After Surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined ASPB and PIPBProcedure or surgery
Ultrasound-guided bilateral anterior serratus plane block combined with bilateral pectoral-intercostal plane block performed after induction of general anesthesia and before surgical incision to provide perioperative multimodal analgesia in patients undergoing cardiopulmonary bypass surgery.
Anterior Serratus Plane BlockProcedure or surgery
Ultrasound-guided bilateral anterior serratus plane block performed after induction of general anesthesia and before surgical incision to provide perioperative analgesia in patients undergoing cardiopulmonary bypass surgery.
| Study group | Role | What they receive |
|---|---|---|
| GroupASPB + PIPB Group | Experimental | Patients in this group received ultrasound-guided bilateral anterior serratus plane block combined with bilateral pectoral-intercostal plane block after induction of general anesthesia and before surgical incision as part of the multimodal analgesia protocol. Receives: Procedure: Combined ASPB and PIPB |
| ASPB Group: | Active comparator | Patients assigned to the ASPB group underwent ultrasound-guided bilateral anterior serratus plane block following induction of general anesthesia and prior to skin incision. The block was incorporated into the perioperative multimodal analgesia protocol. Receives: Procedure: Anterior Serratus Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity
Postoperative pain intensity will be assessed at rest and during coughing using the Visual Analog Scale at extubation (0 hour) and at 4, 8, 12, and 24 hours after surgery. The Visual Analog Scale ranges from 0 to 10 cm, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
Measured: At extubation (0 hour) and at 4, 8, 12, and 24 hours after surgery.
Secondary outcomes (10)
Intraoperative fentanyl consumption
Total dose of fentanyl administered from the induction of anesthesia until the end of surgery. Fentanyl consumption will be recorded in micrograms.
Measured: From induction of anesthesia until the end of surgery.
Postoperative tramadol consumption
Cumulative dose of tramadol administered for rescue analgesia during the first 24 hours after surgery. Tramadol consumption will be recorded in milligrams.
Measured: During the first 24 hours after surgery.
Time to extubation
Time elapsed from the end of surgery until successful removal of the endotracheal tube. Time to extubation will be recorded in hours.
Measured: From the end of surgery until extubation, assessed up to 7 days after surgery.
Intensive care unit length of stay
Time elapsed from postoperative admission to the intensive care unit until discharge from the intensive care unit. Length of stay will be recorded in days.
Measured: From postoperative intensive care unit admission until intensive care unit discharge, assessed up to 30 days after surgery.
Hospital length of stay
Time elapsed from the date of surgery until discharge from the hospital. Hospital length of stay will be recorded in days.
Measured: From the date of surgery until hospital discharge, assessed up to 30 days after surgery.
Incidence of postoperative cardiac arrhythmias
Number of participants who develop a new postoperative cardiac arrhythmia documented by electrocardiography or continuous cardiac monitoring during the index hospitalization. Results will be reported as the number and percentage of participants with at least one cardiac arrhythmia.
Measured: From the end of surgery until hospital discharge, assessed up to 30 days after surgery.
Incidence of block-related complications
Number of participants who develop at least one complication related to the regional anesthesia procedure, including local anesthetic systemic toxicity, vascular puncture, hematoma, infection, pneumothorax, or nerve injury. Results will be reported as the number and percentage of participants with at least one block-related complication.
Measured: From block administration until hospital discharge, assessed up to 30 days after surgery.
Incidence of postoperative surgical complications
Number of participants who develop at least one postoperative surgical complication during the index hospitalization. Results will be reported as the number and percentage of participants with at least one surgical complication.
Measured: From the end of surgery until hospital discharge, assessed up to 30 days after surgery.
Time to thoracic drain removal
Time elapsed from the end of surgery until removal of all thoracic drains. Time to thoracic drain removal will be recorded in hours.
Measured: From the end of surgery until removal of all thoracic drains, assessed up to 30 days after surgery.
Time to urinary catheter removal
Time elapsed from the end of surgery until removal of the urinary catheter. Time to urinary catheter removal will be recorded in hours.
Measured: From the end of surgery until urinary catheter removal, assessed up to 30 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Kılınc, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- LEYLA KILINC, Study chair, şişli etfal eğitim araştırma hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716943
- Sponsor's protocol ID
- 1025
- Status last verified
- Jul 2026
- First submitted
- 28 Jun 2026
- Last updated
- 21 Jul 2026
- 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 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Anterior Serratus Plane and Pectoral-Intercostal Plane Blocks on Perioperative Analgesia and Enhanced Recovery After Surgery in Cardiopulmonary Bypass Surgery
- ClinicalTrials.gov ID
- NCT07716943
- Acronym / sponsor ID
- 1025
- Keywords
- Cardiopulmonary Bypass, Postoperative Pain, Regional Anesthesia, Enhanced Recovery After Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 21 Jul 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.
Cardiopulmonary bypass surgery is associated with significant postoperative pain, which may adversely affect respiratory function, delay mobilization, prolong hospital stay, and increase postoperative complications. Within Enhanced Recovery After Surgery (ERAS) protocols, multimodal analgesia and opioid-sparing strategies have become essential components of perioperative care. Ultrasound-guided fascial plane blocks, including the anterior serratus plane block (ASPB) and pectoral-intercostal plane block (PIPB), have emerged as effective and safe regional anesthesia techniques for cardiac surgery, targeting different sensory innervation of the thoracic wall. However, evidence regarding the combined use of these two blocks remains limited. This study aimed to evaluate whether the combination of ASPB and PIPB improves intraoperative and postoperative analgesia, reduces opioid consumption, and enhances postoperative recovery and ERAS outcomes compared with standard analgesic management in patients undergoing cardiopulmonary bypass surgery.
Detailed description
Cardiac surgery performed with cardiopulmonary bypass (CPB) is associated with substantial perioperative nociceptive stimulation originating from median sternotomy, chest tube placement, internal mammary artery harvesting, and extensive mediastinal tissue manipulation. Despite advances in surgical techniques and perioperative care, postoperative pain remains a major challenge following cardiac surgery. Inadequately controlled pain contributes to impaired respiratory mechanics, ineffective coughing, reduced pulmonary function, delayed mobilization, prolonged intensive care unit (ICU) and hospital stay, and an increased incidence of postoperative pulmonary complications. Furthermore, excessive perioperative opioid administration may lead to respiratory depression, postoperative nausea and vomiting, ileus, delirium, and delayed recovery, highlighting the need for effective opioid-sparing analgesic strategies.
Enhanced Recovery After Surgery (ERAS) protocols have increasingly been adopted in cardiac surgery with the aim of reducing perioperative stress, minimizing complications, and accelerating functional recovery. Contemporary ERAS guidelines emphasize multimodal analgesia as a cornerstone of perioperative management, integrating regional anesthesia techniques with non-opioid systemic analgesics to reduce opioid consumption while improving pain control. Ultrasound-guided fascial plane blocks have gained considerable popularity because they are technically straightforward, provide effective thoracic analgesia, and have a favorable safety profile compared with neuraxial techniques in anticoagulated cardiac surgical patients. Among these techniques, the anterior serratus plane block (ASPB) effectively anesthetizes the lateral thoracic wall by blocking the lateral cutaneous branches of the intercostal nerves, whereas the pectoral-intercostal plane block (PIPB) primarily targets the anterior cutaneous branches responsible for pain arising from median sternotomy. Given their complementary anatomical distributions, combining ASPB and PIPB may provide more comprehensive analgesic coverage of both the anterior and lateral thoracic walls.
Although both ASPB and PIPB have individually demonstrated promising analgesic efficacy in cardiac surgery, evidence regarding the combined use of these two fascial plane blocks remains limited. Whether the addition of ASPB to PIPB results in superior perioperative analgesia, reduced opioid requirements, improved postoperative recovery, and enhanced compliance with ERAS pathways has not yet been clearly established. Therefore, the present study aimed to compare the effects of combined anterior serratus plane block and pectoral-intercostal plane block with standard analgesic management on intraoperative opioid consumption, postoperative pain scores, postoperative analgesic requirements, recovery parameters, and ERAS-related outcomes in patients undergoing cardiopulmonary bypass surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GroupASPB + PIPB Group | Experimental | Procedure: Combined ASPB and PIPBPatients in this group received ultrasound-guided bilateral anterior serratus plane block combined with bilateral pectoral-intercostal plane block after induction of general anesthesia and before surgical incision as part of the multimodal analgesia protocol. |
| ASPB Group: | Active comparator | Procedure: Anterior Serratus Plane BlockPatients assigned to the ASPB group underwent ultrasound-guided bilateral anterior serratus plane block following induction of general anesthesia and prior to skin incision. The block was incorporated into the perioperative multimodal analgesia protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing open heart surgery via median sternotomy by the Cardiovascular Surgery Clinic
- Patients over 18 years of age
- ASA II-III patients
Key exclusion criteria (11 listed)
- - Patients undergoing emergency or recurrent surgery
- Patients with left ventricular ejection fraction < 30
- Patients who died per-operatively
- Patients who do not provide informed consent
- Presence of chronic pain
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 |
|---|---|---|
| Combined ASPB and PIPBUltrasound-guided bilateral anterior serratus plane block combined with bilateral pectoral-intercostal plane block performed after induction of general anesthesia and before surgical incision to provide perioperative multimodal analgesia in patients undergoing cardiopulmonary bypass surgery. | Procedure or surgery | GroupASPB + PIPB Group |
| Anterior Serratus Plane BlockUltrasound-guided bilateral anterior serratus plane block performed after induction of general anesthesia and before surgical incision to provide perioperative analgesia in patients undergoing cardiopulmonary bypass surgery. | Procedure or surgery | ASPB Group: |
Primary outcome
Postoperative pain intensity
Time frame: At extubation (0 hour) and at 4, 8, 12, and 24 hours after surgery.
Postoperative pain intensity will be assessed at rest and during coughing using the Visual Analog Scale at extubation (0 hour) and at 4, 8, 12, and 24 hours after surgery. The Visual Analog Scale ranges from 0 to 10 cm, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
10 secondary outcomes
Intraoperative fentanyl consumption
Time frame: From induction of anesthesia until the end of surgery.
Postoperative tramadol consumption
Time frame: During the first 24 hours after surgery.
Time to extubation
Time frame: From the end of surgery until extubation, assessed up to 7 days after surgery.
Intensive care unit length of stay
Time frame: From postoperative intensive care unit admission until intensive care unit discharge, assessed up to 30 days after surgery.
Hospital length of stay
Time frame: From the date of surgery until hospital discharge, assessed up to 30 days after surgery.
Incidence of postoperative cardiac arrhythmias
Time frame: From the end of surgery until hospital discharge, assessed up to 30 days after surgery.
Incidence of block-related complications
Time frame: From block administration until hospital discharge, assessed up to 30 days after surgery.
Incidence of postoperative surgical complications
Time frame: From the end of surgery until hospital discharge, assessed up to 30 days after surgery.
Time to thoracic drain removal
Time frame: From the end of surgery until removal of all thoracic drains, assessed up to 30 days after surgery.
Time to urinary catheter removal
Time frame: From the end of surgery until urinary catheter removal, assessed up to 30 days after surgery.
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 21 Jul 2026.
- 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.
LEYLA KILINC study chair
şişli etfal eğitim araştırma hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined ASPB and PIPB and Anterior Serratus Plane Block in people with Postoperative Pain and Cardiac Surgery, run by Sisli Hamidiye Etfal Training and Research 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 3 inclusion and 11 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 21 Jul 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 MUSTAFA ALTINAY (05333914422, m_altinay@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity (time frame: At extubation (0 hour) and at 4, 8, 12, and 24 hours after surgery.). 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 21 Jul 2026.