Clinical trial NCT06685445: Continue ESPB & Continue ESPB Combined With SAPB for Thoracotomy
Official title: Continue Erector Spinae Plane Block Versus Continue Erector Spinae Block Combined With Serratus Anterior Plane Block in Patients Undergoing Thoracotomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-thoracotomy Pain
Keywords: Thoracotomy
Postoperative Analgesia
Continous Erector Spinae Block
Serratus Anterior Block
Lead sponsor: Bursa City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-11-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two models for this study. Continous Erector Spinae Block (Group ESPB) group, and Serratus Anterior Plane Block + Continous Erector Spinae Block (Group ESPB+SAPB) group
Primary purpose: TREATMENT

Brief summary: Patients who have undergone thoracotomy experience severe pain in the postoperative period. This pain leads to many complications.

Erector spinae plane block (ESPB) and Serratus anterior plane block (SAPB) are alternative methods to thoracic epidural block (TEB) that provide analgesia in thoracic pain. The application of both blocks and the nerves they affect are different.

The aim of this study is to compare the analgesic efficacy of the combination of ESPB and SAP against ESPB in patients who have undergone thoracotomy

Detailed description: Thoracotomy is one of the most painful surgical operations known. Pain after thoracotomy significantly affects pulmonary function. Factors that cause this pain include cutting and stretching of the ribs, rupture or stretching of the fibrous attachments of the ribs to the vertebral body anteriorly and to the sternal cartilage posteriorly, and cutting of the chest wall muscles. Complications caused by pain include inability to cough due to decreased respiratory movements and inability to expel bronchial secretions, atelectasis, pneumonia, bronchitis, hypoxemia, respiratory failure and prolonged mechanical ventilation.

Effective relief of postoperative pain in patients undergoing thoracic surgery accelerates recovery and reduces the rate of postoperative complications. Thus, the negative effects of postoperative pain can be prevented and early mobilization and shortening of hospital stay can be achieved. Currently, multimodal approaches are used for postoperative analgesia.

Regional anesthesia modalities are often combined with paracetamol, nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids. Ultrasonography (USG)-guided nerve blocks are less invasive and easier to administer than thoracic epidural analgesia and paravertebral blocks for thoracic surgery analgesia. They can be used alone or as part of multimodal analgesia. Pectoral nerve block (PECS), erector spina block (ESPB), transversus abdominis plan (TAP) block and serratus anterior plan block (SAPB), which can also be applied in operations related to the chest wall, are some of them.

SAPB, which can provide analgesia between the second thoracic vertebra (T2) and ninth thoracic vertebra (T9) levels, is one of the plan blocks that can be applied with USG. It has been reported that the application of local anesthetic drugs to the area between the serratus anterior muscle and intercostal muscle in the T2-T9 dermatomes can block the cutaneous branches of the intercostal muscles. It has been found that approximately 12 hours of sensory block can be obtained with SAPB, which can be used in operations related to the chest wall other than thoracic surgery.

Erector spina plan block is a popular fascial plan block in recent years and has been reported to provide effective analgesia in thoracic pain. It has been successfully used in the treatment of pain after both thoracic and abdominal surgery and in the management of chronic thoracic pain. ESPB has the ability to provide analgesia to both anterior and posterior hemithorax, which is particularly effective in pain management after extensive thoracic surgery or trauma (anterior, posterior and lateral chest wall).

Thoracic epidural analgesia is considered the gold standard in the treatment of postoperative pain in thoracic surgery. Considering the invasiveness of TEA, complication rates and application difficulties, alternative methods are needed. At this point, USG-guided ESPB is preferred as an alternative to TEA. However, the fact that ESPB applied after thoracic surgery is insufficient to relieve pain, especially in the chest drain region, raises questions. The main aim of our study is to investigate the hypothesis that the combination of ESPB and SAPB provides more effective analgesic efficacy compared to ESPB alone by relieving pain in the chest drain area in addition to chest wall analgesia after thoracic surgery.

Eligibility criteria: Inclusion Criteria:

* Patients with ASA classification I-III
* Aged 18-80 years
* Who will be scheduled for thoracotomy

Exclusion Criteria:

* Those with psychiatric-neurological diseases that may affect pain perception
* Regular users of antipsychotics, antidepressants
* Allergic to any of the drugs specified in the protocol
* Presence of contraindications to regional anesthesia (infection at the site of the block, bleeding diathesis, etc.)

Primary outcomes:
measure: Postoperative pain scores
timeFrame: at the first 72 hours period postoperatively
Secondary outcomes:
measure: Opioid consumption
timeFrame: Postoperative between 0-4, 4-8, 8-24, 24-48 and 48-72. hours intervals
measure: Requirement for rescue analgesics
timeFrame: Postoperative 72 hours
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa City Hospital
Study officials:
References:
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citation: Toscano A, Capuano P, Costamagna A, Canavosio FG, Ferrero D, Alessandrini EM, Giunta M, Rinaldi M, Brazzi L. Is continuous Erector Spinae Plane Block (ESPB) better than continuous Serratus Anterior Plane Block (SAPB) for mitral valve surgery via mini-thoracotomy? Results from a prospective observational study. Ann Card Anaesth. 2022 Jul-Sep;25(3):286-292. doi: 10.4103/aca.aca_69_21.