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NCT Number: NCT06672848

Comparison of the Effects of Erector Spinae Area (ESP) Block and Thoracic Paravertebral Block (TPVB) on Acute Pain, Postoperative Persistent Pain and Neuropathic Pain in Video-Assisted Thoracoscopic Surgery

VATS is a minimally invasive approach that allows the introduction of a video camera and surgical instruments into the thoracic cavity through small incisions made in the chest wall. The first thoracoscopy was performed by Jacobeus in 1910, and a cystoscope was used in this procedure. Over the years, with the development of surgical techniques and technology, the procedures performed using VATS have diversified. Today, it is used for the diagnosis of pleural diseases and effusions, the staging of lung cancer, lung lobectomies, and the determination of parenchymal diseases.

Respiratory therapy and pain management after extubation are important issues in postoperative care. Adequate postoperative pain control is necessary for a good respiratory effort. The use of intravenous opioids has become the standard in pain management for years. Opioids administered to adequately control pain can cause sedation and respiratory depression. Due to the large number of opioid-related side effects, alternative pain relief methods are being sought. Erector spinae area (ESP) block and thoracic paravertebral block (TPVB) have recently been described for the treatment of pain after thoracic surgery. Although these blocks have been shown to be effective in the treatment of pain after thoracotomy when compared with systemically administered opioids, they have not been compared in terms of the quality of recovery and postoperative pain after minimally invasive thoracic surgery.

The aim of this clinical trial is to compare the effects of Erector Spinae Area (ESP) Block and Thoracic Paravertebral Block (TPVB) on postoperative acute pain in patients scheduled for VATS surgery. The effects of the 2 blocks on postoperative chronic pain and neuropathic pain will also be compared.

Participants:

Their pain status will be recorded for 24 hours after spinal surgery When they come for a follow-up visit 3 months after surgery, 2 tests will be performed to check their pain status.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Elective VATS surgery performed
ASA I-III
18-75 years old

Exclusion criteria

1. Refusal at enrollment 2. Request for withdrawal from the study 3. Inability to give informed consent 4. Emergency surgery 5. Bleeding diathesis 6. Presence of contraindications to the LA agents used in this study 7. Use of chronic opioids 8. Psychiatric disorders 9. Presence of infection at the injection site

Treatment and study plan

Numeretic rating scale (NRS)

Diagnostic Test

NRS is a pain intensity determination system based on the person being asked to describe their pain on a scale of 0 (none), 10 (unbearable pain) and a point between.

Brief Pain Inventory (BPI)

Diagnostic Test

BPI is a chronic pain intensity determination system based on the person being asked to describe their pain on a scale of 0 (none), 10 (unbearable pain) and a point between.

The S-LANSS Pain Score

Diagnostic Test

The Leeds assessment of neuropathic symptoms and signs (LANSS) Pain Scale is based on analysis of sensory description and bedside examination of sensory dysfunction, and provides immediate information in clinical settings. It was developed in two populations of chronic pain patients.

Primary outcomes

acute postoperative pain

Time frame: Patients' pain levels and NRS scores will be recorded in the preoperative period and at the 1st, 6th, 12th, 24th and 48th hours postoperatively.

NRS is a pain intensity determination system based on the person being asked to describe their pain on a scale of 0 (none), 10 (unbearable pain) and a point between

Secondary outcomes

chronic persistent pain and neuropatic pain

Time frame: At the 3rd postoperative month, chronic persistent pain will be evaluated with BPI and neuropathic pain will be evaluated with the S-LANSS scoring system.

BPI Scoring Patients are asked to rate their current symptoms, their average experiences of pain, and the minimum and maximum intensities of their symptoms on scales that range from 0 to 10. A total pain severity score can be found by averag- ing these items or a single item can be treated as the primary outcome measure. A score relating to impact on daily life can be calculated by averag- ing scores on each of the seven items, which also use scales from 0 to 10. Higher scores indicate greater severity and more interference.

Study contacts

Contact information is provided by the study sponsor or research team.

Sinem Prof Dr Sarı

CONTACT

[email protected]

90 256 220 2108

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Nov 4, 2024
Registry last updated: Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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