The Effect of ESPB on Intraoperative Hemodynamics in VATS

NCT05334628 | Completed

• 1 other identifier: E.Kurul-E1-22-2536
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Video-Assisted Thoracoscopic Surgery; Erector Spinae Plane Block; Mean Arterial Pressure; Heart Rate

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Pain scores

  First 24 hours after surgery

Study Arms (2)

Preoperative Erector Spinae Plane Block

ACTIVE COMPARATOR

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

Postperative Erector Spinae Plane Block

ACTIVE COMPARATOR

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

Interventions

Preoperative Erector spinae plane block PROCEDURE

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.

Preoperative Erector Spinae Plane Block

Postperative Erector spinae plane block PROCEDURE

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.

Postperative Erector Spinae Plane Block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (2)

Ankara City Hospital

Çankaya, Ankara, 06290, Turkey (Türkiye)

Location

Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital

Keçiören, Ankara, 06290, Turkey (Türkiye)

Location

Study Officials

• Nilgün Zengin, MD

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 19, 2022
• Study Start: April 11, 2022
• Primary Completion: September 12, 2022
• Study Completion: October 12, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)