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

NCT05160961 | Unknown

• 1 other identifier: E.Kurul-E1-21-2142
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Video-Assisted Thoracoscopic Surgery; Serratus Anterior Plane Block; Erector Spinae Plane Block; Acute Pain; Chronic Pain

Keywords

Serratus anterior plane block; Erector spinae plane block; Acute Pain; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Chronic pain

  3rd month and 6th month

Study Arms (2)

Serratus Anterior Plane Block

ACTIVE COMPARATOR

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

Erector spinae plane block

ACTIVE COMPARATOR

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

Interventions

Serratus anterior plane block PROCEDURE

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.

Also known as: Drug

Serratus Anterior Plane Block

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, when the patient is placed in the lateral decubitus position.

Also known as: Drug

Erector spinae plane block

Eligibility Criteria

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

You may qualify if:

• 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

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

• Atatürk Chest Diseases and Chest Surgery Training and Research Hospital: lead

Study Sites (1)

Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital

Keçiören, Ankara, 06000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Chronic Pain

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Musa Zengin, MD

  Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Musa Zengin, MD

CONTACT

903125677233; musazengin@gmail.com

Ali Alagoz, Assoc Prof

CONTACT

+903125677232; mdalagoz@gmail.com

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: December 3, 2021
• First Posted: December 16, 2021
• Study Start: December 3, 2021
• Primary Completion: June 15, 2024
• Study Completion: July 15, 2024
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)