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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Diagnostic test: Numeretic rating scale (NRS); Diagnostic test: Brief Pain Inventory (BPI); Diagnostic test: The S-LANSS Pain Score

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sinem Prof Dr Sarı; Phone Number: 90 256 220 2108; Email: sarisinem@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: esp block; After anesthesia and surgical procedures, an ESP block will be applied under ultrasonography guidance from the midline 3 cm lateral from the T5 level. After cleaning the area with povidone-iodine before the block, the T5 transverse protrusion will be determined using a linear ultrasound probe. Local anesthetic will be applied between the transverse process and the erector spinae muscle with the help of an insulated needle designed for peripheral block procedures. The location of the needle will be confirmed by hydrodissection with physiological saline without local anesthesia. Once the location of the needle is confirmed, a mixture of 20 ml of 0.25% bupivacaine will be applied.	Diagnostic test: Numeretic rating scale (NRS); 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.; Diagnostic test: Brief Pain Inventory (BPI); 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.; Diagnostic test: The S-LANSS Pain Score; 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.
Other: paravertebral block; Following anesthesia and the surgical procedure, the needle will be advanced at an angle of 30-40° under ultrasonography guidance in the paramedian sagittal plane, lateral to the T5 spinos process, and entered into the location of the superior costotransverse ligament. The location of the serum and needle will be confirmed by hydrodissection without local anesthesia. Once the location of the needle is confirmed, a mixture of 20 ml of 0.25% bupivacaine will be applied.	Diagnostic test: Numeretic rating scale (NRS); 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.; Diagnostic test: Brief Pain Inventory (BPI); 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.; Diagnostic test: The S-LANSS Pain Score; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acute postoperative pain	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	Patients' pain levels and NRS scores will be recorded in the preoperative period and at the 1st, 6th, 12th, 24th and 48th hours postoperatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chronic persistent pain and neuropatic pain	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.	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.

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University

Publications and helpful links

General Publications

• Fu Z, Zhang Y, Zhou Y, Li Z, Wang K, Li H, Jiang W, Liu Z, Cao X. A comparison of paravertebral block, erector spinae plane block and the combination of erector spinae plane block and paravertebral block for post-operative analgesia after video-assisted thoracoscopic surgery: A randomised controlled trial. J Minim Access Surg. 2022 Apr-Jun;18(2):241-247. doi: 10.4103/jmas.JMAS_277_20.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Estimated): November 4, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: November 1, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: postoperative pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pain, Postoperative; Acute Pain; Neuralgia
• Other Study ID Numbers: E-53043469-050.04-613082

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No