Serratus Anterior Plane Block and Serratus Anterior Plane Block + Continuous Wound Infiltration With Catheter
- Conditions
- Postoperative PainMinimal Invasive Cardiac Surgery
- Registration Number
- NCT06971432
- Lead Sponsor
- Ankara City Hospital Bilkent
- Brief 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).
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Visual Analog Scale (VAS) 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 Outcome Measures
Name Time Method Heart Rate 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 postoperativelyMean Arterial Blood Pressure 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 postoperativelyOxygen Saturation 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 postoperativelyVomiting 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.
Itching 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.
Additional Analgesics 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 postoperativelyNausea 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.
Trial Locations
- Locations (1)
Ankara Bilkent City Hospital
🇹🇷Ankara, Çankaya, Turkey