Impact of Thoracic Epidural Versus Serratus Anterior Plane Block Versus Erector Spinae Plane Block on Incidence of PTPS

National Cancer Institute, Egypt

Status: Not yet enrolling

Conditions: Erector Spinae Plane Block; Post-thoracotomy Pain Syndrome; Serratus Anterior Plane Block

Treatments: Procedure: Thoracic epidural infusion; Device: Serratus Anterior Plane Block; Device: Erector Spinae Plane Block

Study type: Interventional

Funder types: Other

Identifiers

NCT05409144

AP2202-30106

Details and patient eligibility

About

The aim of this study is to evaluate the impact of Ultrasound-guided Erector Spinae plane block compared to Ultrasound-guided serratus anterior plane block on the emergence of post-thoracotomy pain syndrome in patients undergoing lobectomy for lung cancer.

Full description

Lung cancer has the highest incidence of all malignancies worldwide and accounts for approximately 13% of all cancer cases. Lung cancer is still the most common cause of cancer-related deaths, and lung resection surgeries could be the main therapeutic option. Hence, the number of thoracotomy procedures is progressively increasing as is the incidence of post-thoracotomy pain. In addition to amputation and mastectomy, thoracotomy is considered the main etiology of severe and long-term acute and chronic post-surgical pain syndromes (CPSPs). The prevalence of post-thoracotomy pain syndrome (PTPS) is widely variable (30%-50%) and may range from 11% to 80%, according to other studies.

The International Association for the Study of Pain (IASP) has defined post-thoracotomy pain syndrome as "pain that recurs or persists along the thoracotomy scar at least 2 months after the procedure". In addition, post-thoracotomy pain syndrome is mostly described with neuropathic manifestations along the thoracotomy scar and in the mammary, inframammary, ipsilateral scapular and interscapular areas.

The ultrasound-guided erector spinae plane (ESP) block is a novel technique for thoracic analgesia that promises to be a relatively simple and safe alternative to more complex and invasive techniques of neural blockade.

Enrollment: 111 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age (18-65) Years
• Physical status American Society of Anesthesiologists Classification II, III
• Patients undergoing lobectomy through lateral thoracotomy
• Body mass index (BMI): (20-40) kg/m2

Exclusion criteria

• Patient refusal.
• Age <18 years or >65 years
• Body mass index (BMI) <20 kg/m2 and >40 kg/m2
• Known sensitivity or contraindication to drugs used in the study
• Contraindication to regional anesthesia e.g. local infection at site of introduction, pre-existing peripheral neuropathies and coagulopathy.
• Pregnancy.
• Physical status American Society of Anesthesiologists Classification IV
• patients on chronic analgesic therapy (daily morphine ≥30 mg or equivalent dose of other opioids or tramadol or any medication for neuropathic pain)
• patients with a history of drug abuse
• patients with neuropsychiatric diseases; patients with a history of chronic pain syndromes that may enhance sensitivity to pain, for example, fibromyalgia
• patients with a history of thoracic surgery through lateral thoracotomy; and patients with recurrent chest malignancies within 3 months.
• All patients who developed severe intra- or post-operative bleeding or required postoperative mechanical ventilation were also excluded from the study.
• Thoracic spine disorders or deformity.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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111 participants in 3 patient groups

Thoracic epidural infusion group

Experimental group

Description:

Patients will receive thoracic epidural preoperative

Treatment:

Procedure: Thoracic epidural infusion

Erector Spinae Plane Block group

Experimental group

Description:

Patients will receive Ultrasound-guided Erector Spinae Plane Block preoperative with an injection of 30 ml levobupivacaine 0.25% and insertion of a catheter

Treatment:

Device: Erector Spinae Plane Block

Serratus Anterior Plane Block group

Experimental group

Description:

Patients will receive Ultrasound-guided Serratus Anterior Plane Block preoperative with an injection of 30 ml levobupivacaine 0.25%.

Treatment:

Device: Serratus Anterior Plane Block