Efficacy of Bi-level ESPB Application in Patients Undergoing VATS

Overview

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.

Full Title of Study: “Comparison of the Efficiency of Bi-Level ESPB and Single-Level ESPB for Postoperative Analgesia in Patients Undergoing VATS”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: October 20, 2022

Interventions

  • Procedure: One-level Erector Spinae Plane Block
    • 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.
  • Procedure: Bi-level Erector Spinae Plane Block
    • 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.

Arms, Groups and Cohorts

  • Active Comparator: One-level Erector Spinae Plane Block
    • After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T5 spinous process, 30 ml of 0.25% bupivacaine hydrochloride will be injected cauda-cranially into the interfacial space below the erector spinae muscle, above the transverse process.
  • Active Comparator: Bi-level Erector Spinae Plane Block
    • After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T4 spinous process, 15 ml of 0.25% bupivacaine hydrochloride will be injected cauda-cranially into the interfacial space below the erector spinae muscle, above the transverse process. Next, the needle will be withdrawn till subcutaneously and the linear US probe will be placed 2-3 cm lateral to the T6 spinous process. Finally, 15 ml of 0.25% bupivacaine hydrochloride will be injected cranio-caudally into the interfacial space below the erector spinae muscle, above the transverse process.

Clinical Trial Outcome Measures

Primary Measures

  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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 Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ankara City Hospital Bilkent
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nilgün Zengin, Principal İnvestigator – Ankara City Hospital Bilkent
  • Overall Contact(s)
    • Nilgün Zengin, MD, +905063370548, nilbavullu@gmail.com

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