Pain, PostoperativeNCT06968065
Comparison of Ultrasound-Guided Serratus Combination Plane Blocks and Local Wound Infiltration for Postoperative Analgesia Management in Minimally Invasive Cardiac Surgery (MICS)
A study testing Ultrasound-guided serratus anterior plane block and serratus-intercostal interfascial plane block with bupivacaine and Local wound infiltration with bupivacaine in people with Pain, Postoperative and Heart Surgery, run by İstanbul Yeni Yüzyıl Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
This randomized, prospective, single-blinded study aims to compare the efficacy of ultrasound-guided serratus anterior plane (SAP) block combined with serratus-intercostal interfascial plane (SIP) block versus local wound infiltration (LWI) for postoperative analgesia in patients undergoing minimally invasive cardiac… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Postoperative, Heart Surgery, Analgesia
- What is being tested?
- Ultrasound-guided serratus anterior plane block and serratus-intercostal interfascial plane block with bupivacaine and Local wound infiltration with bupivacaine
- 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
- 17 Oct 2024to Jun 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Undergoing MICS with left-sided 4th-5th intercostal incision
- ASA I-III
- Informed consent provided
Who cannot join
- Coagulopathy or on anticoagulants
- Allergy to local anesthetics or opioids
- Local infection at block site
- Pregnancy or lactation
- Bilateral thoracic incisions
- Refusal to participate
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
Kolan International Hospital
Istanbul
Ali Şefik Köprülü, MD, +905322677226, askoprulu@yahoo.com
About this study
This randomized, prospective, single-blinded study aims to compare the efficacy of ultrasound-guided serratus anterior plane (SAP) block combined with serratus-intercostal interfascial plane (SIP) block versus local wound infiltration (LWI) for postoperative analgesia in patients undergoing minimally invasive cardiac surgery (MICS). The primary outcome is total perioperative and postoperative opioid consumption. Secondary outcomes include postoperative pain scores (NRS), opioid-related side effects, block-related complications, and ICU stay duration.
Read the detailed description
Minimally invasive cardiac surgery (MICS) has gained popularity due to reduced surgical trauma and faster recovery. However, postoperative pain management remains a challenge. This study evaluates the analgesic effectiveness of combining two interfascial plane blocks-SAP and SIP-under ultrasound guidance, compared to traditional local wound infiltration. A total of 60 patients scheduled for MICS with cardiopulmonary bypass will be randomized into two groups (SAP+SIP vs LWI). Pain scores, opioid usage, and complications will be recorded at predetermined intervals up to 72 hours postoperatively.
- Conditions
- Pain, Postoperative, Heart Surgery, Analgesia
- Being tested
- Ultrasound-guided serratus anterior plane block and serratus-intercostal interfascial plane block with bupivacaine, Local wound infiltration with bupivacaine
- Keywords
- Pain, Postoperative, Heart Surgery, Minimally Invasive, Analgesia, Bupivacaine, Opioid-Related Disorders
- Medical subject headings
- Pain, Postoperative, Agnosia, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided serratus anterior plane block and serratus-intercostal interfascial plane block with bupivacaineProcedure or surgery
Participants will receive an ultrasound-guided serratus anterior plane (SAP) block using 30 mL of 0.25% bupivacaine combined with a serratus-intercostal interfascial plane (SIP) block using 10 mL of 0.25% bupivacaine. Both blocks will be administered after surgery but before emergence from anesthesia. This combination targets multiple interfascial planes to enhance postoperative analgesia in patients undergoing minimally invasive cardiac surgery (MICS).
Local wound infiltration with bupivacaineProcedure or surgery
Participants will receive local wound infiltration with 40 mL of 0.25% bupivacaine applied to the surgical and drain sites following surgery. This approach represents a standard method for managing postoperative pain in MICS patients and serves as the active comparator.
| Study group | Role | What they receive |
|---|---|---|
| SAP + SIP Block Group | Experimental | Participants in this arm will receive a combination of ultrasound-guided serratus anterior plane (SAP) block and serratus-intercostal interfascial plane (SIP) block. The SAP block will be performed using 30 mL of 0.25% bupivacaine, and the SIP block will use 10 mL of 0.25% bupivacaine. Both blocks will be administered after surgery but before emergence from anesthesia. Receives: Procedure: Ultrasound-guided serratus anterior plane block and serratus-intercostal interfascial plane block with bupivacaine |
| Local Wound Infiltration Group | Active comparator | Participants in this arm will receive local wound infiltration (LWI) consisting of 40 mL of 0.25% bupivacaine. The infiltration will be applied to the surgical and drain sites after surgery. Receives: Procedure: Local wound infiltration with bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
o Total opioid consumption (mcg of fentanyl and mg of tramadol) in the first 48 hours postoperatively.
The cumulative perioperative and postoperative opioid consumption measured in micrograms of fentanyl and milligrams of tramadol administered during the first 48 hours after surgery.
Measured: 48 hours
Secondary outcomes (1)
NRS pain scores (static and dynamic) at 0, 2, 4, 8, 16, 24, 48, and 72 hours postoperatively.
Pain intensity will be assessed using the Numeric Rating Scale (NRS) at rest and during movement at predefined postoperative time points (0, 2, 4, 8, 16, 24, 48, and 72 hours).
Measured: 0 to 72 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start17 Oct 2024
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- İstanbul Yeni Yüzyıl Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968065
- Sponsor's protocol ID
- 2024101338
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 13 May 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 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-Guided Serratus Combination Plane Blocks and Local Wound Infiltration for Postoperative Analgesia Management in Minimally Invasive Cardiac Surgery (MICS)
- ClinicalTrials.gov ID
- NCT06968065
- Acronym / sponsor ID
- 2024101338
- Conditions
- Pain, Postoperative, Heart Surgery, Analgesia
- Keywords
- Pain, Postoperative, Heart Surgery, Minimally Invasive, Analgesia, Bupivacaine, Opioid-Related Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- İstanbul Yeni Yüzyıl ÜniversitesiUniversity, hospital or other
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 13 May 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.
This randomized, prospective, single-blinded study aims to compare the efficacy of ultrasound-guided serratus anterior plane (SAP) block combined with serratus-intercostal interfascial plane (SIP) block versus local wound infiltration (LWI) for postoperative analgesia in patients undergoing minimally invasive cardiac surgery (MICS). The primary outcome is total perioperative and postoperative opioid consumption. Secondary outcomes include postoperative pain scores (NRS), opioid-related side effects, block-related complications, and ICU stay duration.
Detailed description
Minimally invasive cardiac surgery (MICS) has gained popularity due to reduced surgical trauma and faster recovery. However, postoperative pain management remains a challenge. This study evaluates the analgesic effectiveness of combining two interfascial plane blocks-SAP and SIP-under ultrasound guidance, compared to traditional local wound infiltration. A total of 60 patients scheduled for MICS with cardiopulmonary bypass will be randomized into two groups (SAP+SIP vs LWI). Pain scores, opioid usage, and complications will be recorded at predetermined intervals up to 72 hours postoperatively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAP + SIP Block Group | Experimental | Procedure: Ultrasound-guided serratus anterior plane block and serratus-intercostal interfascial plane block with bupivacaineParticipants in this arm will receive a combination of ultrasound-guided serratus anterior plane (SAP) block and serratus-intercostal interfascial plane (SIP) block. The SAP block will be performed using 30 mL of 0.25% bupivacaine, and the SIP block will use 10 mL of 0.25% bupivacaine. Both blocks will be administered after surgery but before emergence from anesthesia. |
| Local Wound Infiltration Group | Active comparator | Procedure: Local wound infiltration with bupivacaineParticipants in this arm will receive local wound infiltration (LWI) consisting of 40 mL of 0.25% bupivacaine. The infiltration will be applied to the surgical and drain sites after surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75 years
- Undergoing MICS with left-sided 4th-5th intercostal incision
- ASA I-III
- Informed consent provided
Key exclusion criteria (6 listed)
- Coagulopathy or on anticoagulants
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 |
|---|---|---|
| Ultrasound-guided serratus anterior plane block and serratus-intercostal interfascial plane block with bupivacaineParticipants will receive an ultrasound-guided serratus anterior plane (SAP) block using 30 mL of 0.25% bupivacaine combined with a serratus-intercostal interfascial plane (SIP) block using 10 mL of 0.25% bupivacaine. Both blocks will be administered after surgery but before emergence from anesthesia. This combination targets multiple interfascial planes to enhance postoperative analgesia in patients undergoing minimally invasive cardiac surgery (MICS). | Procedure or surgery | SAP + SIP Block Group |
| Local wound infiltration with bupivacaineParticipants will receive local wound infiltration with 40 mL of 0.25% bupivacaine applied to the surgical and drain sites following surgery. This approach represents a standard method for managing postoperative pain in MICS patients and serves as the active comparator. | Procedure or surgery | Local Wound Infiltration Group |
Primary outcome
o Total opioid consumption (mcg of fentanyl and mg of tramadol) in the first 48 hours postoperatively.
Time frame: 48 hours
The cumulative perioperative and postoperative opioid consumption measured in micrograms of fentanyl and milligrams of tramadol administered during the first 48 hours after surgery.
1 secondary outcome
NRS pain scores (static and dynamic) at 0, 2, 4, 8, 16, 24, 48, and 72 hours postoperatively.
Time frame: 0 to 72 hours postoperatively.
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 13 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided serratus anterior plane block and serratus-intercostal interfascial plane block with bupivacaine and Local wound infiltration with bupivacaine in people with Pain, Postoperative and Heart Surgery, run by İstanbul Yeni Yüzyıl Üniversitesi 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 4 inclusion and 6 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 13 May 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 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 Selcuk Alver, MD (+905435424234, alverselcuk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
o Total opioid consumption (mcg of fentanyl and mg of tramadol) in the first 48 hours postoperatively. (time frame: 48 hours). 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 13 May 2025.