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

NCT06971432 | Completed

• 1 other identifier: SAPB / SAPB + LİA
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Minimal Invasive Cardiac Surgery

Keywords

minimal invasive cardiac surgery

Outcome Measures

Primary Outcomes (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

  48 hours

Secondary Outcomes (7)

• Heart Rate

  48 hours

• Mean Arterial Blood Pressure

  48 hours

• Oxygen Saturation

  48 hours

• Additional Analgesics

  48 hours

• Nausea

  48 hours

Study Arms (2)

Group SAPB

EXPERIMENTAL

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. 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.

Procedure: Group SAPB

Group SAPB + LIA

EXPERIMENTAL

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.

Procedure: Group SAPB + LIA

Interventions

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

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.

Group SAPB + LIA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 31417264 RESULT

• 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.

  PMID: 32417925 RESULT

• 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.

  PMID: 30505564 RESULT

• 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.

  PMID: 30340525 RESULT

• 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.

  PMID: 37470524 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Model Details: 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.

Study Record Dates

• First Submitted: May 4, 2025
• First Posted: May 14, 2025
• Study Start: April 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 15, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)