Continue ESPB & Continue ESPB Combined With SAPB for Thoracotomy

December 15, 2025 updated by: Mursel Ekinci, Bursa City Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group EPSB (Continue Erector Spinae Plane Block)
Following induction of anesthesia, ESPB will be performed with 30 ml of 0.25% bupivacaine (Marcaine®) and a catheter will be placed before the start of surgery. 15 ml of 0.125% bupivacaine solution will be administered through the ESPB catheter at 12-hour intervals following the end of surgery. All participants will be attached to a patient-controlled analgesia (PCA) device prepared with 5 mg/ml tramadol (Contramal®) as soon as they are admitted to the recovery room. PCA will be non-infusion, with a lockout period of 20 minutes and a bolus dose of 10 mg. In the postoperative period, 1 g paracetamol (Parol®) will be administered intravenously every 8 hours, 75 mg diclofenac (Dikloron®) intramuscularly if NRS≥4 and 0.5 mg/kg meperidine (Aldolan®) intravenously if NRS≥4 is still present after 2 hours.
Drug: Active 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
Other Names:
  • Postoperative analgesia management
Active Comparator: Group ESPB+SAPB (Continue Erector Spinae Plane Block + Serratus Anterior Plane Block)
Following induction of anesthesia, ESPB with 30 ml of 0.25% bupivacaine (Marcaine®) will be performed and the catheter will be placed before the surgery starts. After the end of surgery, SAPB with 30 ml of 0.25% bupivacaine will be performed before extubation. Following the end of the surgery, 15 ml of 0.125% bupivacaine solution will be administered through the ESPB catheter at 12-hour intervals. All participants will be attached to a patient-controlled analgesia device prepared with 5 mg/ml tramadol (Contramal®) as soon as they are admitted to the recovery room. There will be no infusion in PCA, 20 minutes lock time, 10 mg bolus dose. In the postoperative period, 1 g paracetamol (Parol®) will be administered intravenously every 8 hours, 75 mg intramuscular diclofenac (Dikloron®) if NRS≥ 4 and 0.5 mg/kg meperidine (Aldolan®) intravenously if NRS≥ 4 is still present after 2 hours.
Drug: Active 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.
Other Names:
  • Postoperative analgesia management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain scores
Time Frame: at the first 72 hours period postoperatively

Pain 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
at the first 72 hours period postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: Postoperative between 0-4, 4-8, 8-24, 24-48 and 48-72. hours intervals
Total 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.
Postoperative between 0-4, 4-8, 8-24, 24-48 and 48-72. hours intervals
Requirement for rescue analgesics
Time Frame: Postoperative 72 hours

The 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.
Postoperative 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bursa City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2024

Primary Completion (Actual)

February 10, 2025

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

November 11, 2024

First Submitted That Met QC Criteria

November 11, 2024

First Posted (Actual)

November 12, 2024

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Bursa City Hospital 10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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