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

NCT ID: NCT06672848

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2026-05-01

Brief Summary

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: OTHER

Numeretic rating scale (NRS)

Intervention Type: 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)

Intervention Type: 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

Intervention Type: 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.

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.

Group Type: OTHER

Numeretic rating scale (NRS)

Intervention Type: 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)

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aydin Adnan Menderes University

OTHER

Sponsor Role: lead

Responsible Party

SINEM SARI

MD, Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Sinem Prof Dr Sarı

Role: CONTACT

sarisinem@yahoo.com

90 256 220 2108

References

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.

Reference Type: RESULT

PMID: 33885016 (View on PubMed)

Other Identifiers

E-53043469-050.04-613082

Identifier Type: -

Identifier Source: org_study_id