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CompletedNCT05083845Updated Jul 12, 2022

The Effect of Different Local Anesthetic Volumes on Postoperative Analgesia for Thoracotomy Patients With Erector Spinae Plane Block

An interventional study of Same blocks with different local anesthetic volume in Erector Spinae Plane Block, Local Anesthetic and Thoracotomy, sponsored by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-07-12.

Sponsored by Atatürk Chest Diseases and Chest Surgery Training and Research Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

It is widely accepted that thoracotomy causes severe acute pain. This increases the frequency of postoperative pulmonary complications and postoperative morbidity. Many analgesic methods have been proposed for thoracotomy pain, including thoracic epidural analgesia (TEA), thoracic paravertebral block (TPVB), intercostal nerve blocks (ICSB), erector spinae plane block (ESPB), serratus anterior plane block (SAPB). Among these methods, ultrasound-guided TPVB and ESPB are the most used methods. TPVB has left its place to newer techniques such as ESPB due to its proximity to the pleura and its deeper location. ESPB is more superficial, easy to access, and less likely to have complications. In addition, ESPB application is increasing in patients who underwent thoracotomy and VATS. There is no consensus on the dose of analgesia in these studies. There are studies on volumes between 10 ml and 40 ml in the literature. In this study, it was aimed to compare the volumes of 20 ml and 30 ml containing local anesthetic at the same concentration (0.25% bupivacaine) of ESPB block to be performed with USG in patients who underwent thoracotomy.

02

Conditions studied

  • Erector Spinae Plane Block
  • Local Anesthetic
  • Thoracotomy
  • Postoperative Analgesia
03

In context

Lead sponsor

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital is the lead sponsor of 28 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18 to 65 years old
  • ASA physical status I-II-III
  • BMI 18 to 30 kg/m2
  • Elective thoracotomy surgery

Exclusion criteria

Exclusion Criteria:

  • Patient refusing the procedure
  • Emergency surgery
  • History of chronic opioid or analgesic used
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Erector Spinae Plane Block with 20 ml %0.25 Bupivacaine

    Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine was injected into the area.

    Procedure: Same blocks with different local anesthetic volume

  • Active comparator
    Erector Spinae Plane Block with 30 ml %0.25 Bupivacaine

    Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 30 ml 0.25% bupivacaine was injected into the area.

    Procedure: Same blocks with different local anesthetic volume

Interventions

  • ProcedureSame blocks with different local anesthetic volume

    Erector spinae plane block with different local anesthetic volumes will be applied to the patients under real-time ultrasound guidance.

06

What researchers measure

Primary outcomes

  1. Pain Scores

    Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th, 24th and 48th hours after surgery.

    Time frame: 48 hours after surgery

Secondary outcomes

  1. Morphine Consumption

    Morphine consumption for 24 hours will be recorded

    Time frame: 24 hours after surgery

07

Study locations

1 site
  • Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
    Kecioren, Ankara 06000, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05083845
Lead sponsor
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Responsible party
Musa Zengin (Principal İnvestigator, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital) — Principal investigator
First posted
Oct 19, 2021
Start date
Aug 25, 2021
Primary completion
Jun 9, 2022
Completion
Jul 9, 2022
Last update
Jul 12, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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