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Continue ESPB & Continue ESPB Combined With SAPB for Thoracotomy

Continue Erector Spinae Plane Block Versus Continue Erector Spinae Block Combined With Serratus Anterior Plane Block in Patients Undergoing Thoracotomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06685445
Enrollment
60
Registered
2024-11-12
Start date
2024-10-18
Completion date
2025-03-01
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-thoracotomy Pain

Keywords

Thoracotomy, Postoperative Analgesia, Continous Erector Spinae Block, Serratus Anterior Block

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.

Interventions

DRUGActive Comparator: Continue Erector Spinae Plane Block

For the block, the ultrasound (USG)probe will be placed longitudinally 2-3 cm lateral to the transverse process of the T4-5 vertebra. The erector spinae muscle will be visualized above the hyperechoic transverse process. Using in plane technique, the block needle will be advanced in the cranio-caudal direction and 5 ml of saline will be injected under the erector spinae muscle to confirm the block site. After the block site is confirmed, 30 ml of 0.25% bupivacaine (Marcain 0.5%® AstraZeneca, England) will be administered. The block catheter (Perifix® Braun, Germany) will then be inserted to block area

DRUGActive Comparator: Continue Erector Spinae Plane Block + Serratus Anterior Plane Block

For ESPB, USG probe will be placed longitudinally 2-3 cm lateral to the transverse process of the T4-5 vertebra. The erector spinae muscle will be visualized above the hyperechoic transverse process. Using in plane technique, the block needle will be advanced in the cranio-caudal direction and 5 ml of saline will be injected under the erector spinae muscle to confirm the block site and 30 ml of 0.25% bupivacaine (Marcain®) will be administered. The block catheter (Perifix®) will be inserted. For SAPB, the USG probe will be placed parasagittal to the mid-axillary line at the 5th-6th rib level and the anechoic shadow of the costa together with the latissumus dorsi and serratus anterior muscles will be visualized. Then using in plane technique, the block needle will be advanced in the cranio-caudal direction and 5 ml of saline will be injected under the serratus anterior muscle and the block site will be confirmed and 30 ml of 0.25% bupivacaine will be administered.

Sponsors

Bursa City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The patient and the outcomes assessor who performs postoperative pain evaluation will not know the group

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain scoresat the first 72 hours period postoperativelyPain scores (Numerical rating scale) (0-meaning no pain to 10-meaning worst pain imaginable) during postoperative 72 hours period. Active NRS (when moving, coughing,) Passive NRS (Inactivity) Active and passive NRS scores of both groups of participants will be questioned at 1, 2, 4, 6, 12, 24, 48 and 72. hours. NRS scores between both groups will be compared

Secondary

MeasureTime frameDescription
Opioid consumptionPostoperative between 0-4, 4-8, 8-24, 24-48 and 48-72. hours intervalsTotal concentration of tramadol (mg) consumption of the participants in both groups will be evaluated by PCA at 0-4, 4-8, 8-24, 24-48 and 48-72. hours postoperatively and comparison between the groups will be made.
Requirement for rescue analgesicsPostoperative 72 hoursThe need for rescue analgesia will be recorded at the first 72 hours period postoperatively Both groups of participants will be checked for the requirement of diclofenac as a rescue analgesic until the 72nd postoperative hour. Both groups of participants will be checked for the requirement of meperidine as a rescue analgesic until the 72nd postoperative hour.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026