The Effect of ESPB on Intraoperative Hemodynamics in VATS

NCT ID: NCT05334628

Last Updated: 2022-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-11
• Study Completion Date: 2022-10-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Preoperative Erector spinae plane block

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Postperative Erector spinae plane block

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Nilgün Zengin

Principal İnvestigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nilgün Zengin, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Locations

Ankara City Hospital

Çankaya, Ankara, Turkey (Türkiye)

Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital

Keçiören, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E.Kurul-E1-22-2536

Identifier Type: -

Identifier Source: org_study_id