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Postoperative PainMICSNCT06971432

Serratus Anterior Plane Block and Serratus Anterior Plane Block + Continuous Wound Infiltration With Catheter

A study testing Group SAPB and Group SAPB + LIA in people with Postoperative Pain and Minimal Invasive Cardiac Surgery, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A total of 46 patients scheduled to undergo elective coronary artery bypass surgery via a minimally invasive technique will be included in the study. In the preoperative period, patients will be randomly assigned into two groups using the sealed envelope method (SAPB / PECS II). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Group SAPB and Group SAPB + LIA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2024to 15 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

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

  • Women and men aged 18-75,
  • ASA I-II-III risk group,
  • Body mass index between 18-35,
  • who will undergo coronary artery bypass surgery with minimally invasive cardiac surgery method

Who cannot join

  • Those under 18 and over 75
  • Those with advanced comorbidities
  • Those with ASA score IV
  • Those with a history of bleeding diathesis and those using drugs that cause bleeding disorders
  • Patients with an infection in the area where the block will be performed
  • Patients who are allergic to the local anesthetic agent to be used
Show all 10Show fewer
  • Patients with a body mass index (BMI) under 18 and over 35 will be excluded from the study.
  • Withdrawal criteria:
  • Patients who want to leave the study group
  • Patients who develop surgical complications will be removed from the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Bilkent City Hospital

    Ankara, Çankaya, 06800

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Effectiveness of Serratus Anterior Plane Block and Serratus Anterior Plane Block + Continuous Wound Infiltration With Catheter on Postoperative Pain After Minimally Invasive Cardiac Surgery

A total of 46 patients scheduled to undergo elective coronary artery bypass surgery via a minimally invasive technique will be included in the study. In the preoperative period, patients will be randomly assigned into two groups using the sealed envelope method (SAPB / PECS II).

Upon arrival in the operating room, patients will undergo ECG and SpO₂ monitoring, followed by intra-arterial cannulation for continuous blood pressure monitoring. Anesthesia induction will be performed with 1 mg/kg lidocaine, 2-3 mg/kg propofol, 3 mcg/kg fentanyl, and 0.6 mg/kg rocuronium. Following endotracheal intubation, jugular vein cannulation will be performed.

Read more

Group 1:

Deep and superficial serratus anterior plane block (SAPB) will be performed at the level of the 5th rib. A total of 40 ml of 0.25% bupivacaine will be administered-20 ml into each compartment.

Group 2:

Deep and superficial serratus anterior plane block (SAPB) will be performed at the level of the 5th rib. A total of 40 ml of 0.25% bupivacaine will be administered-20 ml into each compartment.At the end of the surgical procedure, while the incision line is still open, a catheter will be placed in the subcutaneous tissue, at the most lateral part of the incision. A 0.20% bupivacaine solution will be prepared and at the end of the operation, a 10 ml bolus will be administered, followed by a 2 ml/hour infusion for 48 hours.

The following variables will be recorded: patient age, height, body weight, BMI, gender, type of analgesia administered, diagnosis, surgical procedure performed, any complications during or after the procedure, postoperative visual analogue scale (VAS) pain scores, additional postoperative analgesic use, patient satisfaction, postoperative nausea and vomiting, ICU length of stay, and total hospital length of stay.

All patients will routinely receive paracetamol 1 g four times daily. If the VAS score is 4 or higher, 100 mg of tramadol HCl will be administered.

Read the detailed description

SAPB :Using ultrasound guidance, the needle is advanced in-plane at approximately 45° toward the fifth rib. For the superficial SAPB, the local anesthetic is injected anteriorly to the serratus anterior in the plane created with the latissimus dorsi muscle. The thoracodorsal artery runs in this plane, and while care should be taken not to puncture this vessel, the spread of the injectate around the vessel confirms the appropriate injection plane. For the deep SAPB, the local anesthetic is injected anteriorly to the rib and deep to the serratus anterior.

Being tested
Group SAPB, Group SAPB + LIA
Keywords
minimal invasive cardiac 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.

  • Group SAPBProcedure or surgery

    Using ultrasound guidance, the needle is advanced in-plane at approximately 45° toward the fifth rib. For the superficial SAPB, the local anesthetic is injected anteriorly to the serratus anterior in the plane created with the latissimus dorsi muscle. The thoracodorsal artery runs in this plane, and while care should be taken not to puncture this vessel, the spread of the injectate around the vessel confirms the appropriate injection plane. For the deep SAPB, the local anesthetic is injected anteriorly to the rib and deep to the serratus anterior. Deep and superficial serratus anterior plane block (SAPB) will be performed at the level of the 5th rib. A total of 40 ml of 0.25% bupivacaine will be administered-20 ml into each compartment. All patients will routinely receive paracetamol 1 g four times daily. If the VAS score is 4 or higher, 100 mg of tramadol HCl will be administered.

  • Group SAPB + LIAProcedure or surgery

    SAPB is applied similarly to the other group.Deep and superficial serratus anterior plane block (SAPB) will be performed at the level of the 5th rib. A total of 40 ml of 0.25% bupivacaine will be administered-20 ml into each compartment.At the end of the surgical procedure, while the incision line is still open, a catheter will be placed in the subcutaneous tissue, at the most lateral part of the incision. A 0.20% bupivacaine solution will be prepared and at the end of the operation, a 10 ml bolus will be administered, followed by a 2 ml/hour infusion for 48 hours.

    All patients will routinely receive paracetamol 1 g four times daily. If the VAS score is 4 or higher, 100 mg of tramadol HCl will be administered.

Study groups in NCT06971432
Study groupRoleWhat they receive
Group SAPBExperimentalSAPB :Using ultrasound guidance, the needle is advanced in-plane at approximately 45° toward the fifth rib. For the superficial SAPB, the local anesthetic is injected anteriorly to the serratus anterior in the plane created with the latissimus dorsi muscle. The thoracodorsal artery runs in this plane, and while care should be taken not to puncture this vessel, the spread of the injectate around the vessel confirms the appropriate injection plane. For the deep SAPB, the local anesthetic is injected anteriorly to the rib and deep to the serratus anterior. Deep and superficial serratus anterior plane block (SAPB) will be performed at the level of the 5th rib. A total of 40 ml of 0.25% bupivacaine will be administered-20 ml into each compartment. All patients will routinely receive paracetamol 1 g four times daily. If the VAS score is 4 or higher, 100 mg of tramadol HCl will be administered.
Receives: Procedure: Group SAPB
Group SAPB + LIAExperimentalSAPB is applied similarly to the other group. Deep and superficial serratus anterior plane block (SAPB) will be performed at the level of the 5th rib. A total of 40 ml of 0.25% bupivacaine will be administered-20 ml into each compartment.At the end of the surgical procedure, while the incision line is still open, a catheter will be placed in the subcutaneous tissue, at the most lateral part of the incision. A 0.20% bupivacaine solution will be prepared and at the end of the operation, a 10 ml bolus will be administered, followed by a 2 ml/hour infusion for 48 hours. All patients will routinely receive paracetamol 1 g four times daily. If the VAS score is 4 or higher, 100 mg of tramadol HCl will be administered.
Receives: Procedure: Group SAPB + LIA

What is being measured

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

  1. Visual Analog Scale (VAS)

    The patient will be visited at postoperative hours 0, 3, 6, 12, and 24, and their pain will be assessed. The patient will be asked to provide a number from 0 to 10 to rate the intensity of their pain, and the response will be recorded. A score of 0 indicates no pain, and 10 indicates unbearable, severe pain. Measurements will be taken four times:

    T4: 6th hour postoperatively

    T5: 12th hour postoperatively

    T6: 24th hour postoperatively

    T7: 48th hour postoperatively

    Measured: 48 hours

Secondary outcomes (7)
  1. Heart Rate

    ECG monitoring was performed on the patient, and both rhythm and heart rate were observed. Heart rate was recorded as a numeric value per second. Measurements will be taken seven times:

    T1: Before induction

    T2: Within 5 minutes after the cardiopulmonary perfusion pump reaches full flow

    T3: Within 5 minutes after weaning from the cardiopulmonary perfusion pump

    T4: 6th hour postoperatively

    T5: 12th hour postoperatively

    T6: 24th hour postoperatively

    T7: 48th hour postoperatively

    Measured: 48 hours

  2. Mean Arterial Blood Pressure

    Intra-arterial cannulation and monitoring were established before induction. Mean arterial blood pressure was measured and recorded in mmHg. Measurements will be taken seven times:

    T1: Before induction

    T2: Within 5 minutes after the cardiopulmonary perfusion pump reaches full flow

    T3: Within 5 minutes after weaning from the cardiopulmonary perfusion pump

    T4: 6th hour postoperatively

    T5: 12th hour postoperatively

    T6: 24th hour postoperatively

    T7: 48th hour postoperatively

    Measured: 48 hours

  3. Oxygen Saturation

    Oxygen saturation was measured using a pulse oximeter on the second finger of the hand. It was recorded as a numeric value between 0 and 100. Measurements will be taken seven times:

    T1: Before induction

    T2: Within 5 minutes after the cardiopulmonary perfusion pump reaches full flow

    T3: Within 5 minutes after weaning from the cardiopulmonary perfusion pump

    T4: 6th hour postoperatively

    T5: 12th hour postoperatively

    T6: 24th hour postoperatively

    T7: 48th hour postoperatively

    Measured: 48 hours

  4. Additional Analgesics

    It will be assessed whether there is a need for additional analgesics within the first 24 hours. If additional analgesics are required, it will be recorded whether tramadol was administered. If it was, the number of times it was required and the dosage given will be noted. Assessments will be made at the following time points:

    T4: 6th hour postoperatively

    T5: 12th hour postoperatively

    T6: 24th hour postoperatively

    T7: 48th hour postoperatively

    Measured: 48 hours

  5. Nausea

    The patient will be interviewed and assessed for the frequency of opioid-related side effects during hospital visits. The patient will be visited at postoperative hours 6, 12, 24, and 48, and their nausea will be evaluated. The patient will be asked to rate the severity of their nausea on a scale from 0 to 10. A score of 0 indicates no nausea, while 10 indicates severe nausea.

    Measured: 48 hours

  6. Vomiting

    The patient will be interviewed and assessed for the frequency of opioid-related side effects during hospital visits. The patient will be visited at postoperative hours 6, 12, 24, and 48, and vomiting will be evaluated. If the patient has vomited, the number of episodes will be recorded. The total number of vomiting episodes within 48 hours will be documented.

    Measured: 48 hours

  7. Itching

    The patient will be interviewed and assessed for the frequency of opioid-related side effects during hospital visits. They will be evaluated at 6, 12, 24, and 48 hours postoperatively and asked whether they are experiencing pruritus. If present, the severity will be rated as mild, moderate, or severe.

    Measured: 48 hours

Timeline

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

  1. First posted14 May 2025
  2. Study start1 Apr 2024
  3. Primary completion1 Dec 2024
  4. Study completion15 Dec 2024

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
Among the patients planned to undergo elective minimally invasive coronary bypass surgery, those who met the inclusion criteria were divided into two groups using the sealed envelope method by a researcher who would not be involved in any other phase of the study. After intubation and central vein cannulation were performed during the intraoperative period, the block method selected for the patient was applied. Patient data were recorded during the perioperative period.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06971432
Sponsor's protocol ID
SAPB / SAPB + LİA
Acronym
MICS
Status last verified
May 2025
First submitted
4 May 2025
Last updated
15 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jannati M, Attar A. Analgesia and sedation post-coronary artery bypass graft surgery: a review of the literature. Ther Clin Risk Manag. 2019 Jun 20;15:773-781. doi: 10.2147/TCRM.S195267. eCollection 2019.

    PubMed 31417264
  • Ekinci M, Ciftci B, Golboyu BE, Demiraran Y, Bayrak Y, Tulgar S. A Randomized Trial to Compare Serratus Anterior Plane Block and Erector Spinae Plane Block for Pain Management Following Thoracoscopic Surgery. Pain Med. 2020 Jun 1;21(6):1248-1254. doi: 10.1093/pm/pnaa101.

    PubMed 32417925
  • Thompson C, French DG, Costache I. Pain management within an enhanced recovery program after thoracic surgery. J Thorac Dis. 2018 Nov;10(Suppl 32):S3773-S3780. doi: 10.21037/jtd.2018.09.112.

    PubMed 30505564
  • Berthoud V, Ellouze O, Nguyen M, Konstantinou M, Aho S, Malapert G, Girard C, Guinot PG, Bouchot O, Bouhemad B. Serratus anterior plane block for minimal invasive heart surgery. BMC Anesthesiol. 2018 Oct 20;18(1):144. doi: 10.1186/s12871-018-0614-5.

    PubMed 30340525
  • Saikat S, Shweta S, Somalia M, Dibyendu K, Sushan M. Comparative efficacy of serratus anterior plane block (SAPB) and fentanyl for postoperative pain management and stress response in patients undergoing minimally invasive cardiac surgery (MICS). Ann Card Anaesth. 2023 Jul-Sep;26(3):268-273. doi: 10.4103/aca.aca_91_22.

    PubMed 37470524

Questions about this trial

What is this clinical trial studying?

A study testing Group SAPB and Group SAPB + LIA in people with Postoperative Pain and Minimal Invasive Cardiac Surgery, run by Ankara City Hospital Bilkent 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 10 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: finished, as of the sponsor's last update on 15 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) (time frame: 48 hours). 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 NCT06971432, which also lists 5 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 15 May 2025.

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