Comparison of Interpectoral+Serratus Anterior Block With Erector Spinae Block in Minimally Invasive Cardiac Surgery

NCT05743231 | Completed DMC

• 1 other identifier: 2022.212.11.13
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Adequate pain management after minimally invasive cardiac surgery is essential for early ambulation and patient satisfaction. However, an incision similar to thoracotomy surgery is made by entering between the ribs, and a severely painful postoperative period is experienced as the intercostal nerves are cut. Invasive cardiac surgery is necessary surgery that can take steps to improve the quality of life and functional status of patients without sternotomy. However, patients may experience intense pain in the immediate postoperative period, which can lead to inactivity, increased risk of complications, and greater consumption of opioids, resulting in adverse effects and prolonged hospital stays. Pain management is challenging due to a large number of dermatomes covered. Interpectoral plane block + serratus anterior plane block, defined in 2012, has been used in many studies before as part of multimodal analgesia in minimally invasive cardiac surgery. Erector spinae block was also described in 2018 with positive results, which has been used in both sternotomies (open heart surgery) and minimally invasive procedures. Minimally invasive cardiac surgery can be excruciating in the postoperative period, just like thoracotomy surgeries. What is aimed in this study is to compare two previously known regional anesthesia techniques in this study.

Conditions

Postoperative Pain

Keywords

pain management; regional anesthesia; minimally invasive cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale (NRS) Pain Score at 24 Hours

  A numerical ratio scale (NRS) requires the patient to rate pain on a defined scale. ifor example,0-10 where 0 is no pain and 10 is the worst pain imaginable.

  24 hours after surgery, following extubation

Secondary Outcomes (5)

• opioid consumption

  up to 48 hours

• recovery criteria

  up to 48 hours

• intraoperative

  up to 48 hours

• CPOT score until extubation

  up to extubation time.

• NRS at 6, 12, and 48 hours

  From surgery to 6 hours, 12 hours, and 48 hours postoperatively

Study Arms (2)

interpectoral area block + serratus anterior area block group (IPSA)

ACTIVE COMPARATOR

Interpectoral plane block + serratus anterior plane block will be performed randomly on the participants.

Procedure: interpectoral area block + serratus anterior area block group

erector spinae group (ES)

ACTIVE COMPARATOR

Erector spinae block will be performed randomly on the participants

Procedure: interpectoral area block + serratus anterior area block group

Interventions

interpectoral area block + serratus anterior area block group PROCEDURE

The interpectoral and serratus anterior area blocks will be applied immediately after general anesthesia is given to the participants under ultrasound guidance. 30 ml of 0.25% bupivacaine will be used for two blocks.

Also known as: IPSA

erector spinae group (ES); interpectoral area block + serratus anterior area block group (IPSA)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who will undergo cardiac surgery for the first time
• ASA I-III (American Society of Anesthesiology classification) patients between the ages of 18-75
• Patients with an average bleeding profile
• Patients who gave written consent to participate in the study
• Patients without local anesthetic allergy and a history
• Patients who have the intellectual level to use the patient-controlled analgesia device

You may not qualify if:

• Patients who have undergone open heart surgery before undergoing valve replacement and revision
• Patients who did not agree to participate in the study
• Patients with cancer primarily
• Patients with local anesthetic allergy and a history
• Patients who do not have the intellectual level to use a patient-controlled analgesia device
• Patients with abnormal bleeding profile
• Patients who were re-operated due to any surgical complication (bleeding, etc.) within the 24th hour after the operation

Sponsors & Collaborators

• Namik Kemal University: lead

Study Sites (1)

Namık Kemal University

Tekirdağ, Süleymanpaşa, 59100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants will be randomly divided into two groups. The physician who will collect data in the cardiac surgery intensive care unit and cardiac surgery clinic will not know which group the participant is in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 24, 2023
• Study Start: November 29, 2022
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)