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Post-thoracotomy PainNCT06685445

Continue ESPB & Continue ESPB Combined With SAPB for Thoracotomy

A study testing Active Comparator: Continue Erector Spinae Plane Block and Active Comparator: Continue Erector Spinae Plane Block + Serratus Anterior Plane Block in people with Post-thoracotomy Pain, run by Bursa City Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Post-thoracotomy Pain
What is being tested?
Active Comparator: Continue Erector Spinae Plane Block and Active Comparator: Continue Erector Spinae Plane Block + Serratus Anterior Plane Block
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
18 Oct 2024to 1 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bursa City Hospital

    Bursa, 16000

Other trials in Turkey (Türkiye)

About this study

Official title: 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

Read the 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.

Being tested
Active Comparator: Continue Erector Spinae Plane Block, Active Comparator: Continue Erector Spinae Plane Block + Serratus Anterior Plane Block
Keywords
Thoracotomy, Postoperative Analgesia, Continous Erector Spinae Block, Serratus Anterior Block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active Comparator: Continue Erector Spinae Plane BlockDrug

    Also called Postoperative analgesia management

    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

  • Active Comparator: Continue Erector Spinae Plane Block + Serratus Anterior Plane BlockDrug

    Also called Postoperative analgesia management

    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.

Study groups in NCT06685445
Study groupRoleWhat they receive
Group EPSB (Continue Erector Spinae Plane Block)Active comparatorFollowing 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.
Receives: Drug: Active Comparator: Continue Erector Spinae Plane Block
Group ESPB+SAPB (Continue Erector Spinae Plane Block + Serratus Anterior Plane Block)Active comparatorFollowing 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.
Receives: Drug: Active Comparator: Continue Erector Spinae Plane Block + Serratus Anterior Plane Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative pain scores

    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

    Measured: at the first 72 hours period postoperatively

Secondary outcomes (2)
  1. Opioid consumption

    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.

    Measured: Postoperative between 0-4, 4-8, 8-24, 24-48 and 48-72. hours intervals

  2. Requirement for rescue analgesics

    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.

    Measured: Postoperative 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start18 Oct 2024
  3. Primary completion10 Feb 2025
  4. Study completion1 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06685445
Sponsor's protocol ID
Bursa City Hospital 10
Status last verified
Dec 2025
First submitted
11 Nov 2024
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Deng B, Qian K, Zhou JH, Tan QY, Wang RW. Optimization of Chest Tube Management to Expedite Rehabilitation of Lung Cancer Patients After Video-Assisted Thoracic Surgery: A Meta-Analysis and Systematic Review. World J Surg. 2017 Aug;41(8):2039-2045. doi: 10.1007/s00268-017-3975-x.

    PubMed 28289835
  • Nagahiro I, Andou A, Aoe M, Sano Y, Date H, Shimizu N. Pulmonary function, postoperative pain, and serum cytokine level after lobectomy: a comparison of VATS and conventional procedure. Ann Thorac Surg. 2001 Aug;72(2):362-5. doi: 10.1016/s0003-4975(01)02804-1.

    PubMed 11515867
  • Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.

    PubMed 23923989
  • Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

    PubMed 27501016
  • Savage C, McQuitty C, Wang D, Zwischenberger JB. Postthoracotomy pain management. Chest Surg Clin N Am. 2002 May;12(2):251-63. doi: 10.1016/s1052-3359(02)00011-x.

    PubMed 12122825
  • 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.

    PubMed 35799555

Questions about this trial

What is this clinical trial studying?

A study testing Active Comparator: Continue Erector Spinae Plane Block and Active Comparator: Continue Erector Spinae Plane Block + Serratus Anterior Plane Block in people with Post-thoracotomy Pain, run by Bursa City Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain scores (time frame: at the first 72 hours period postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06685445, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

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