Clinical trial NCT05743231: Comparison of Interpectoral+Serratus Anterior Block With Erector Spinae Block in Minimally Invasive Cardiac Surgery
Official title: Comparison of Interpectoral Area Block+Serratus Anterior Area Block With Erector Spinae Block in Minimally Invasive Cardiac Surgery, Effect on Postoperative Pain and Recovery; Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: pain management
regional anesthesia
minimally invasive cardiac surgery
Lead sponsor: Namik Kemal University
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Minimally 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.

The interpectoral plane block + serratus anterior plane block seems to cover the thoracic dermatomes. It has been the subject of many studies in the same surgical group. Minimally invasive cardiac surgery can be excruciating in the postoperative period, just like thoracotomy surgeries. What is aimed of this study is to compare it with erector spinae block in this study. Additional anesthetic techniques, such as peripheral nerve blocks, are part of the multimodal analgesic strategy and are often used to manage acute pain better. Inadequate treatment can lead to persistent pain conditions. Although numerous nerve blocks exist for this purpose, some may fail because they do not cover the thoracic dermatomes or their entire innervation. The central hypothesis of this study hypothesis, interpectoral plane block + serratus anterior plane block, defined in 2012, has been used in many previous studies as part of multimodal analgesia in minimally invasive cardiac surgery. Erector spinae block was also described in 2018 with positive results that have been used in both sternotomies (open heart surgery) and minimally invasive procedures. In this randomized clinical trial, the study aims to compare the efficacy of previously known field blocks as part of multimodal analgesia in minimally invasive cardiac surgery. As presented in the literature, these techniques have been routinely performed so much that review articles have been written. Targeted in this study, preliminary results will be postoperative pain scores. At Namık Kemal University anesthesia clinic, It is regularly used as part of multimodal analgesia and resident training. Traditional intravenous analgesia methods cause many undesirable side effects depending on the type of opioid used, and they are insufficient compared to regional anesthesia methods.

The main aim of this study is to investigate the effectiveness of these two methods, routinely used in thoracic surgery.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Numerical Rating Scale (NRS) Pain Score at 24 Hours
timeFrame: 24 hours after surgery, following extubation
Secondary outcomes:
measure: opioid consumption
timeFrame: up to 48 hours
measure: recovery criteria
timeFrame: up to 48 hours
measure: intraoperative
timeFrame: up to 48 hours
measure: CPOT score until extubation
timeFrame: up to extubation time.
measure: NRS at 6, 12, and 48 hours
timeFrame: From surgery to 6 hours, 12 hours, and 48 hours postoperatively
Other outcomes:
Locations:
city: Tekirdağ
country: Turkey
facility: Namık Kemal University
state: Süleymanpaşa
Study officials:
References: