Clinical trial NCT06971432: Serratus Anterior Plane Block and Serratus Anterior Plane Block + Continuous Wound Infiltration With Catheter
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Minimal Invasive Cardiac Surgery
Keywords: minimal invasive cardiac surgery
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 48 hours
Secondary outcomes:
measure: Heart Rate
timeFrame: 48 hours
measure: Mean Arterial Blood Pressure
timeFrame: 48 hours
measure: Oxygen Saturation
timeFrame: 48 hours
measure: Additional Analgesics
timeFrame: 48 hours
measure: Nausea
timeFrame: 48 hours
measure: Vomiting
timeFrame: 48 hours
measure: Itching
timeFrame: 48 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
state: Çankaya
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.