The Effect of ESPB on Intraoperative Hemodynamics in VATS

The Effect of Erector Spinae Plane Block on Intraoperative Hemodynamics in Video-Assisted Thoracoscopic Surgery

Video-assisted thoracic surgery (VATS) is frequently applied in thoracic surgery operations. VATS has become the standard procedure in minor and major lung surgeries. In recent years, regional anesthesia techniques have also been frequently applied to patients for pain relief. Thoracic paravertebral block (TPVB), erector spinae plane block (ESPB), and serratus anterior plane block (SAPB) are also among the regional anesthesia techniques frequently used in thoracic surgery.

General anesthesia (GA) is the main method of anesthesia for thoracic surgery. However, GA can only inhibit the projection system of the cortical limbic system or hypothalamic cortex. GA cannot completely block the transmission of peripheral noxious stimulus to the central nervous system and cannot effectively inhibit the intraoperative stress response. With the addition of peripheral blocks such as TPVB, ESPB, and SAPB, more stable hemodynamics is expected by providing preemptive analgesia in patients. As a result of all these; In this study, we aimed to compare the intraoperative hemodynamic changes of patients who underwent preoperative ESPB in patients who will undergo VATS resection under GA with those who underwent postoperative ESPB.

Study Overview

• Status: Completed
• Conditions: Erector Spinae Plane Block; Heart Rate; Mean Arterial Pressure; Video-Assisted Thoracoscopic Surgery
• Intervention / Treatment: Procedure: Preoperative Erector spinae plane block; Procedure: Postperative Erector spinae plane block

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara
    • Keçiören, Ankara, Turkey, 06290
      • Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
    • Çankaya, Ankara, Turkey, 06290
      • Ankara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• Advanced cancer
• History of chronic analgesic therapy
• History of local anesthetic allergy
• Infection in the intervention area
• Patients with bleeding disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Preoperative Erector Spinae Plane Block; In the preoperative period, under general anesthesia, 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 into the interfacial space below the erector spinae muscle, above the transverse process.	Procedure: Preoperative Erector spinae plane block; 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.
ACTIVE_COMPARATOR: Postperative Erector Spinae Plane Block; In the postoperative period, under general anesthesia, 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 into the interfacial space below the erector spinae muscle, above the transverse process.	Procedure: Postperative Erector spinae plane block; Erector spinae plane block will be performed unilaterally, under US guidance, after the surgical operation, under general anesthesia, and when the patient is placed in the lateral decubitus position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean arterial pressure	Mean arterial pressure values will be recorded before anesthesia, before surgical incision, after surgical incision at 5th, 30th, 60th, 90th, 120th minutes, and after general anesthesia.	Perioperative period
Heart rate	Heart rate values will be recorded before anesthesia, before surgical incision, after surgical incision at 5th, 30th, 60th, 90th, 120th minutes, and after general anesthesia.	Perioperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 the 1st, 2nd, 4th, 12th, and 24th hours after surgery.	First 24 hours after surgery

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 11, 2022
• Primary Completion (ACTUAL): September 12, 2022
• Study Completion (ACTUAL): October 12, 2022

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (ACTUAL): April 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: E.Kurul-E1-22-2536

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No