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Completed

NCT Number: NCT05427955

Efficacy of Bi-level ESPB Application in Patients Undergoing VATS

Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block and erector spina plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In recent years, the frequency of application of plane blocks as a component of multimodal analgesia has been increased. ESPB is one of them. Although there are publications showing that single-level ESPB applied from the T5 vertebra level spreads in the craniocaudal T3-L2 range, there are also publications stating that the spread is more limited. This study, it was aimed to compare the efficacy of bi-level ESPB application and one-level ESPB application for postoperative analgesia in patients undergoing VATS.

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Key information

Conditions

Pain, Postoperative Erector Spinae Plane Block Multimodal Analgesia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Thoracic Surgery, Video-Assisted

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Atatürk Chest Diseases and Thoracic Surgery Training and Research Hospital, Keçiören, Ankara, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 80 years
  • American Society of Anesthesiologists physical status I-II-III
  • Body mass index between 18-40 kg/m2
  • Patients undergoing elective video-assisted thoracoscopic surgery

Exclusion criteria

  • Patient refusing the procedure
  • History of chronic analgesic or opioid therapy
  • History of local anesthetic allergy
  • Infection in the intervention area
  • Emergency surgery

Treatment and study plan

One-level Erector Spinae Plane Block

Procedure

One-level Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, and when the patient is placed in the lateral decubitus position. In applications, 30 ml of 0.25% bupivacaine will be injected at the T5 level.

Bi-level Erector Spinae Plane Block

Procedure

Bi-level Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, and when the patient is placed in the lateral decubitus position. In applications, 15 ml of 0.25% bupivacaine at T4 level and 15 ml of 0.25% bupivacaine at T6 level will be injected.

Primary outcomes

  1. Pain scores

    Time frame: 1st hour after surgery

    Pain will be assessed at the first-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

  2. Pain scores

    Time frame: 2nd-hour after surgery.

    Pain will be assessed at the 2nd-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

  3. Pain scores

    Time frame: 4th-hour after surgery.

    Pain will be assessed at the 4th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

  4. Pain scores

    Time frame: 12th-hour after surgery.

    Pain will be assessed at the 12th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

  5. Pain scores

    Time frame: 24th-hour after surgery.

    Pain will be assessed at the 24th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

  6. Pain scores

    Time frame: 48th-hour after surgery.

    Pain will be assessed at the 48th-hour rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).

Secondary outcomes

  1. Morphine Consumption

    Time frame: 24 hours after surgery

    Postoperative intravenous morphine infusion therapy will be administered with the patient-controlled analgesia (PCA) method. Thanks to PCA, how much morphine the patient needs will be followed in mg.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Comparison of the Efficiency of Bi-Level ESPB and Single-Level ESPB for Postoperative Analgesia in Patients Undergoing VATS

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jun 22, 2022
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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