Postoperative PainNCT07175298
Efficacy of Serratus Posterior Superior Intercostal Plane Block on Post-operative Pain in Cardiac Surgery.
A study testing conventional opioid-based technique and SPSIPB Group in people with Postoperative Pain and Cardiac Surgery, run by Alexandria University at 1 site in Egypt.
Trial summary
Cardiac surgery, particularly procedures involving median sternotomy, is associated with significant postoperative pain. Acute postoperative pain is severe in cardiac patients undergoing sternotomy, and pain intensity is more severe than expected. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain, Cardiac Surgery
- What is being tested?
- conventional opioid-based technique and SPSIPB Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2025to Mar 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged 18 to 60
- both sexes
- who are scheduled to have fast-tracking elective on-pump cardiac surgery through a median sternotomy,
- American Society of Anesthesiologists Physical status II-III,
- Ability to understand and provide informed consent
Who cannot join
- patients who refused to participate in the study,
- who had Cognitive impairment or mental disorders,
- Ages <18 and >60 years,
- BMI <18 and >35,
- patients with puncture site infection,
- patients who documented allergy to local anesthetic drugs,
- patients used to take chronic pain medications, patients who made previous sternotomy or chest surgery
- patients with a history of substance abuse.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of medicine ,Alexandria university
Alexandria, Alexandria Governorate, 21521
Hesham ELgoweini, Prof.Dr., 00201287740750, ethics.comm@alexmed.edu.eg
Islam LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE, Dr
About this study
Official title: Efficacy of Serratus Posterior Superior Intercostal Plane Block on Post-operative Pain Management in Patients Undergoing Adult Cardiac Surgery. A Randomized Controlled Trial
Cardiac surgery, particularly procedures involving median sternotomy, is associated with significant postoperative pain. Acute postoperative pain is severe in cardiac patients undergoing sternotomy, and pain intensity is more severe than expected. Poorly controlled pain after surgery can lead to myocardial ischemia and pulmonary infections.Regional anesthesia techniques offer a promising alternative or adjunct to systemic opioids, providing targeted pain relief with fewer systemic side effects. The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) is a novel regional anesthesia technique that involves injecting local anesthetic into the fascial plane between the serratus posterior superior muscle and the intercostal muscles
Read the detailed description
Cardiac surgery, particularly procedures involving median sternotomy, is associated with significant postoperative pain. Acute postoperative pain is severe in cardiac patients undergoing sternotomy, and pain intensity is more severe than expected. Poorly controlled pain after surgery can lead to myocardial ischemia and pulmonary infections.
Effective pain management is crucial for patient recovery, reducing complications, and facilitating early mobilization. Opioids are commonly used for postoperative analgesia but are associated with numerous side effects, including respiratory depression, nausea, vomiting, constipation, and prolonged hospitalization.
Regional anesthesia techniques offer a promising alternative or adjunct to systemic opioids, providing targeted pain relief with fewer systemic side effects. The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) is a novel regional anesthesia technique that involves injecting local anesthetic into the fascial plane between the serratus posterior superior muscle and the intercostal muscles. This block will provide analgesia to the anterolateral and posterior chest wall, covering dermatomes relevant to cardiac surgery.
Preliminary case reports and small studies suggest its efficacy in thoracic and cardiac surgeries, demonstrating effective pain control and reduced opioid consumption. However, a randomized controlled trial is necessary to definitively determine the efficacy and safety of SPSIPB as part of multimodal analgesia in adult cardiac surgery.
Fascial plane blocks in regional anesthesia have gained importance in recent years. It involves injection into a tissue plane to provide analgesia and is an alternative to neuraxial and paravertebral techniques. It is often safer and is associated with less cardiorespiratory instability or complications compared to epidural analgesia.
The primary objective of the study is to examine the effect of adding preemptive SPSIPB to general anesthesia in adult cardiac surgery through sternotomy on the postoperative opioid consumption. The secondary objectives will include time to extubation, the intensity of postoperative pain, time to 1st rescue analgesia, patient satisfaction, and any possible side effects of the study drugs and technique.
- Conditions
- Postoperative Pain, Cardiac Surgery
- Being tested
- conventional opioid-based technique, SPSIPB Group
- Keywords
- The Serratus Posterior Superior Intercostal Plane 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.
conventional opioid-based techniqueProcedure or surgery
Control Group: Participants will receive general anaesthesia with a conventional opioid-based technique
SPSIPB GroupProcedure or surgery
SPSIPB Group: Participants will receive an ultrasound-guided Serratus posterior superior intercostal plane block with 30 ml 0.25% bupivacaine per side pre-incision and general anaesthesia with opioid based fentanyl
| Study group | Role | What they receive |
|---|---|---|
| Control Group: PCS fentanyl based | Active comparator | Control Group: Participants will receive general anaesthesia with a conventional opioid-based technique(fentanyl) Receives: Procedure: conventional opioid-based technique |
| The Serratus Posterior Superior Intercostal Plane Block group | Experimental | SPSIPB Group: Participants will receive an ultrasound-guided Serratus posterior superior intercostal plane block with 30 ml 0.25% bupivacaine per side pre-incision and general anaesthesia with opioid based fentanyl Receives: Procedure: SPSIPB Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total postoperative fentanyl consumption
will be measured as the total amount of fentanyl (in micrograms) consumed via PCA
Measured: the first 24 and 48 hours post-extubation.
Secondary outcomes (6)
Time to extubation
duration (minutes) between ICU admission and endotracheal extubation.
Measured: post operative 6 hour
Time to first rescue analgesia
Time from extubation to the first request for PCA bolus.
Measured: 48hour post operatively
Postoperative pain intensity
Assessed using the Critical-Care Pain Observation Tool (CPOT) during intubation and the Numerical Rating Scale (NRS), at 6, 12, 18,24, 36, and 48 hours post-extubation. The CPOT ranges from 0 to 8, and the NRS ranges from 0 (no pain) to 10 (worst possible pain).
Measured: 6, 12, 18,24, 36, and 48 hours post-extubation.
Patient satisfaction
Assessed using a 5-point Likert scale ( 1-Very dissatisfied 2-Dissatisfied 3-Neutral 4-Satisfied 5-Very satisfied)
Measured: at 24 hours post-extubation
Length of stay
total hospital stay (days).
Measured: post operative 5 days
Incidence of adverse
- Related to local anesthesia toxicity (neurologic or cardiovascular events).
- Related to block procedure (hematoma and pneumothorax, nerve injury).
- Related to opioid administration (postoperative nausea and vomiting, dizziness, and pruritus, respiratory depression (respiratory rate < 10breaths/min or SpO2 < 90% on room air)).
Measured: 28hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionMar 2026 (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.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Elbardan, Alexandria University
- Investigators
- Islam LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE, Dr, Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175298
- Sponsor's protocol ID
- 0307518
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 16 Sep 2025
- 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 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Serratus Posterior Superior Intercostal Plane Block on Post-operative Pain Management in Patients Undergoing Adult Cardiac Surgery. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07175298
- Acronym / sponsor ID
- 0307518
- Conditions
- Postoperative Pain, Cardiac Surgery
- Keywords
- The Serratus Posterior Superior Intercostal Plane Block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 16 Sep 2025 (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.
Cardiac surgery, particularly procedures involving median sternotomy, is associated with significant postoperative pain. Acute postoperative pain is severe in cardiac patients undergoing sternotomy, and pain intensity is more severe than expected. Poorly controlled pain after surgery can lead to myocardial ischemia and pulmonary infections.Regional anesthesia techniques offer a promising alternative or adjunct to systemic opioids, providing targeted pain relief with fewer systemic side effects. The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) is a novel regional anesthesia technique that involves injecting local anesthetic into the fascial plane between the serratus posterior superior muscle and the intercostal muscles
Detailed description
Cardiac surgery, particularly procedures involving median sternotomy, is associated with significant postoperative pain. Acute postoperative pain is severe in cardiac patients undergoing sternotomy, and pain intensity is more severe than expected. Poorly controlled pain after surgery can lead to myocardial ischemia and pulmonary infections.
Effective pain management is crucial for patient recovery, reducing complications, and facilitating early mobilization. Opioids are commonly used for postoperative analgesia but are associated with numerous side effects, including respiratory depression, nausea, vomiting, constipation, and prolonged hospitalization.
Regional anesthesia techniques offer a promising alternative or adjunct to systemic opioids, providing targeted pain relief with fewer systemic side effects. The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) is a novel regional anesthesia technique that involves injecting local anesthetic into the fascial plane between the serratus posterior superior muscle and the intercostal muscles. This block will provide analgesia to the anterolateral and posterior chest wall, covering dermatomes relevant to cardiac surgery.
Preliminary case reports and small studies suggest its efficacy in thoracic and cardiac surgeries, demonstrating effective pain control and reduced opioid consumption. However, a randomized controlled trial is necessary to definitively determine the efficacy and safety of SPSIPB as part of multimodal analgesia in adult cardiac surgery.
Fascial plane blocks in regional anesthesia have gained importance in recent years. It involves injection into a tissue plane to provide analgesia and is an alternative to neuraxial and paravertebral techniques. It is often safer and is associated with less cardiorespiratory instability or complications compared to epidural analgesia.
The primary objective of the study is to examine the effect of adding preemptive SPSIPB to general anesthesia in adult cardiac surgery through sternotomy on the postoperative opioid consumption. The secondary objectives will include time to extubation, the intensity of postoperative pain, time to 1st rescue analgesia, patient satisfaction, and any possible side effects of the study drugs and technique.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group: PCS fentanyl based | Active comparator | Procedure: conventional opioid-based techniqueControl Group: Participants will receive general anaesthesia with a conventional opioid-based technique(fentanyl) |
| The Serratus Posterior Superior Intercostal Plane Block group | Experimental | Procedure: SPSIPB GroupSPSIPB Group: Participants will receive an ultrasound-guided Serratus posterior superior intercostal plane block with 30 ml 0.25% bupivacaine per side pre-incision and general anaesthesia with opioid based fentanyl |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- aged 18 to 60
- both sexes
- who are scheduled to have fast-tracking elective on-pump cardiac surgery through a median sternotomy,
- American Society of Anesthesiologists Physical status II-III,
- Ability to understand and provide informed consent
Key exclusion criteria (8 listed)
- patients who refused to participate in the study,
- who had Cognitive impairment or mental disorders,
- Ages <18 and >60 years,
- BMI <18 and >35,
- patients with puncture site infection,
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 |
|---|---|---|
| conventional opioid-based techniqueControl Group: Participants will receive general anaesthesia with a conventional opioid-based technique | Procedure or surgery | Control Group: PCS fentanyl based |
| SPSIPB GroupSPSIPB Group: Participants will receive an ultrasound-guided Serratus posterior superior intercostal plane block with 30 ml 0.25% bupivacaine per side pre-incision and general anaesthesia with opioid based fentanyl | Procedure or surgery | The Serratus Posterior Superior Intercostal Plane Block group |
Primary outcome
Total postoperative fentanyl consumption
Time frame: the first 24 and 48 hours post-extubation.
will be measured as the total amount of fentanyl (in micrograms) consumed via PCA
6 secondary outcomes
Time to extubation
Time frame: post operative 6 hour
Time to first rescue analgesia
Time frame: 48hour post operatively
Postoperative pain intensity
Time frame: 6, 12, 18,24, 36, and 48 hours post-extubation.
Patient satisfaction
Time frame: at 24 hours post-extubation
Length of stay
Time frame: post operative 5 days
Incidence of adverse
Time frame: 28hour postoperative
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 16 Sep 2025.
- 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.
Islam LECTURER OF ANESTHESIA AND SURGICAL INTENSIVE CARE, Dr principal investigator
University of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional opioid-based technique and SPSIPB Group in people with Postoperative Pain and Cardiac Surgery, run by Alexandria University at 1 site in Egypt.
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 5 inclusion and 8 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 16 Sep 2025. 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 Egypt. 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 ISLAM ELBARDAN, MD (00201112278083, Islam.elbardan@Alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total postoperative fentanyl consumption (time frame: the first 24 and 48 hours post-extubation.). 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 16 Sep 2025.