US-Guided SAPB Versus ESPB on Acute and Chronic Pain After VATS

Comparison of the Effects of Ultrasound-guided Serratus Anterior Plane Block and Erector Spinae Plane Block on Postoperative Acute and Chronic Pain for Patients Who Underwent Video-assisted Thoracoscopic Surgery.

Postoperative acute and chronic pain is frequently observed in patients undergoing video assisted thoracoscopic surgery (VATS). This prolongs the discharge time of patients and increases the frequency of postoperative pulmonary complications. Recently, alternative analgesic methods such as thoracic paravertebral block (TPVB), erector spinae plane block (ESPB), and serratus anterior plane block (SAPB) which are thought to have less side effects than thoracic epidural analgesia, have been used. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In addition, ESPB and SAPB application is increasing in patients undergoing VATS. In the literature, the number of cases performed with ESPB and SAPB and randomized controlled prospective studies with ESPB and SAPB are increasing. In this study, it is planned to compare the effects of US-guided SAPB and ESPB on postoperative acute and chronic pain in patients undergoing VATS.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Postoperative Pain; Acute Pain; Erector Spinae Plane Block; Serratus Anterior Plane Block; Video-Assisted Thoracoscopic Surgery
• Intervention / Treatment: Procedure: Serratus anterior plane block; Procedure: Erector spinae plane block

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

Contacts and Locations

• Study Contact: Name: Musa Zengin, MD; Phone Number: 903125677233; Email: musazengin@gmail.com
• Study Contact Backup: Name: Ali Alagoz, Assoc Prof; Phone Number: +903125677232; Email: mdalagoz@gmail.com

Study Locations

• Turkey
  • Ankara
    • Kecioren, Ankara, Turkey, 06000
      • Recruiting
      • Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
      • Contact: Musa Zengin, MD; Phone Number: +903125677233; Email: musazengin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 18 and 65 years
• American Society of Anesthesiologists physical status I-II-III
• Body mass index between 18-30 kg/m2
• Patients undergoing elective video assiste 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 Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Erector spinae plane block; After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T5 spinous process, 20 ml of 0.25% bupivacaine hydrochloride will be injected into the interfacial space below the erector spinae muscle, above the transverse process.	Procedure: Erector spinae plane block; Erector spinae plane block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the lateral decubitus position.; Other Names: Drug
Active Comparator: Serratus Anterior Plane Block; Following the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique beneath the serratus anterior muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine will be injected into the area.	Procedure: Serratus anterior plane block; Serratus anterior plane block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the lateral decubitus position.; Other Names: Drug

What is the study measuring?

Primary 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 1st, 2nd, 4th, 8th, 16th and 24th hours after surgery.	First 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic pain	Chronic pain findings will be evaluated in the 3rd month and 6th month after surgery by using visual analog from 0 (no pain) to 10 (worst pain). Neuropathic pain symptoms (Burning, stabbing, or electric shock-like pain; tingling, numbness, or a "pins and needles" feeling, hyperalgesia, allodynia and hypoesthesia) will also be asked to the participants in the 3rd month and 6th month after surgery.	3rd month and 6th month

Collaborators and Investigators

• Sponsor: Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
• Investigators: Principal Investigator: Musa Zengin, MD, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2021
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): July 15, 2024

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Pain; Erector spinae plane block; Acute Pain; Serratus anterior plane block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Acute Pain
• Other Study ID Numbers: E.Kurul-E1-21-2142

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