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Completed

NCT Number: NCT06971432

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

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.

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.

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Key information

Conditions

Postoperative Pain Minimal Invasive Cardiac Surgery Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Group SAPB

Procedure

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 + LIA

Procedure

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.

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 48 hours

    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

Secondary outcomes

  1. Heart Rate

    Time frame: 48 hours

    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

  2. Mean Arterial Blood Pressure

    Time frame: 48 hours

    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

  3. Oxygen Saturation

    Time frame: 48 hours

    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

  4. Additional Analgesics

    Time frame: 48 hours

    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

  5. Nausea

    Time frame: 48 hours

    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.

  6. Vomiting

    Time frame: 48 hours

    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.

  7. Itching

    Time frame: 48 hours

    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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study 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

Acronym: MICS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 14, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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