ESPB Versus Perioperative Iv Lidocaine Infusion on Proinflammatory Cytokines in Breast Cancer Surgeries

NCT ID: NCT07108959

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-12-31

Brief Summary

The present study aims to compare the effect of ESPB versus perioperative iv lidocaine infusion on proinflammatory cytokines in breast cancer surgeries.

Detailed Description

Breast surgery is a widely performed procedure worldwide, with a significant number of patients experiencing moderate to severe acute pain (30 50%) and developing chronic post-surgical pain (CPSP) (25-68%). CPSP, characterized by persistent or worsening pain in the breast region lasting for at least 3 months after surgery, can have detrimental effects on emotional well being, functional abilities, quality of life, and impose substantial financial burdens on healthcare systems. The pathophysiology of CPSP involves mechanisms such as traumatic nerve injury, neuroinflammation, and central neuronal sensitization. Stress response to cancer surgeries is usually associated with a group of interactions between the endocrinal, the sympathetic, and the immunological systems resulting in imbalance between pro- and anti-inflammatory cytokines in addition to activating an inflammatory cascade. Exaggerated production of inflammatory mediators (e.g. interleukins [ILs] and tumor necrosis factor alpha [TNFα]), and immune cell dysfunction (e.g. CD4 T) can lead to haemodynamic instability or metabolic derangements besides increasing the susceptibility of postoperative infection, resulting in delaying wound healing, multiple organ dysfunction, and postoperative morbidity. Tissue and peripheral nerve injury leads to a local inflammatory reaction accompanied by increased levels of pro-inflammatory cytokines, including interleukin IL-1 and IL-6, which induce peripheral and central nervous system sensitization leading to hyperalgesia. IL-1 induces long-lasting synthesis and release of substance P from peripheral nerve terminals of primary afferent neurons, which may contribute to neurogenic inflammation. The conventional approach to managing postoperative pain relies heavily on opioids, which carries the risk of adverse effects including respiratory depression, addiction, and even mortality. To address these challenges, multimodal analgesic strategies have been proposed to alleviate both acute and chronic postoperative pain following breast surgery. Lidocaine, being used originally as an antiarrhythmic agent, has been found to possess antinociceptive, anti-inflammatory and anti-hyperalgesia properties, making it a potentially useful drug for relieving postoperative pain.

The systemic administration of lidocaine has shown efficacy in relieving neuropathic pain. Previous meta-analyses have demonstrated the effectiveness of intravenous lidocaine in reducing postoperative pain and opioid consumption in patients undergoing spine and abdomen surgery. However, the efficacy of intravenous lidocaine specifically for breast surgery has not been extensively evaluated due to limitations such as small sample sizes and conflicting findings from individual studies. To supply complete analgesia postoperatively for patients undergoing breast surgeries, it is essential to ideally block the dermatomes of the spinal nerves from C5 to T6. Many techniques have been used widely to control pain after breast surgeries as para vertebral block, epidural block, and intercostal block. Although no optimal method has been defined yet, each one of these techniques has some flaws. Epidural block can lead to unwanted block to the opposite side, epidural abscess, epidural haematoma and accidental dural puncture. Paravertebral block can result in an ideal analgesia, but it has drawback that it can be complicated by pneumothorax and it may be difficult to perform. The intercostal nerve block is simple to apply, but it requires to be performed in several segments.

Conditions

Breast Cancer; ESPB; Lidocaine Infusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group E

patients will receive ultrasound guided ESPB with 30 ml bupivacaine 0.25%.

Group Type: ACTIVE_COMPARATOR

Erector spinae plane block (Group E)

Intervention Type: PROCEDURE

The ultra sound probe will be placed on the paravertebral region in a Sagittal plane about 3 cm lateral to the T5 spinous process on the operating side to locate erector spinae muscle, rhomboid major and trapezius from inward (To reach T5, we used C7 as an anatomical landmark, which is the most prominent vertebrae in the back and count downwards to reach T5. To locate C7, we will use palpation or ultrasound guidance if there is difficulty in palpation). Following visualization of these muscles and the transverse process of T5, the skin will be infiltrated with 5 ml of 2% lidocaine, and then 30 ml bupivacaine 0.25% will be injected in the plane between the erector spinae muscle and transverse process using a 22-G 10-cm nerve block needle.

Group L

Patients will receive 1.5mg/kg lidocaine 2%; intravenously as a bolus dose then 1.5mg/kg/hr lidocaine infusion using a 50cc syringe pump intraoperatively.

Group Type: ACTIVE_COMPARATOR

Lidocaine (drug)

Intervention Type: PROCEDURE

Patients in group L will receive an initial bolus of lidocaine 1.5mg /kg over 10 minutes immediately before the induction of general anaesthesia then 1.5mg/kg/hr lidocaine infusion in a 50cc syringe pump intra operatively that will be stopped at the end of surgery.

Interventions

Erector spinae plane block (Group E)

The ultra sound probe will be placed on the paravertebral region in a Sagittal plane about 3 cm lateral to the T5 spinous process on the operating side to locate erector spinae muscle, rhomboid major and trapezius from inward (To reach T5, we used C7 as an anatomical landmark, which is the most prominent vertebrae in the back and count downwards to reach T5. To locate C7, we will use palpation or ultrasound guidance if there is difficulty in palpation). Following visualization of these muscles and the transverse process of T5, the skin will be infiltrated with 5 ml of 2% lidocaine, and then 30 ml bupivacaine 0.25% will be injected in the plane between the erector spinae muscle and transverse process using a 22-G 10-cm nerve block needle.

Intervention Type: PROCEDURE

Lidocaine (drug)

Patients in group L will receive an initial bolus of lidocaine 1.5mg /kg over 10 minutes immediately before the induction of general anaesthesia then 1.5mg/kg/hr lidocaine infusion in a 50cc syringe pump intra operatively that will be stopped at the end of surgery.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age 30 -60 years.
• Female patients.
• ASA physical status class I - II.
• Elective resectable non metastatic breast cancer.

Exclusion Criteria

• Patients with history of sensitivity to the studied drugs.
• Patients with cardiac conduction defects.
• Patients with major spine deformities.
• Patients with severe coagulopathy.
• Patients with infection at injection site.
• Patients with preexisting myopathy or neuropathy because it can worsen neurological deficits and increase sensitivity to local anaesthetic toxicity. Additionally, it complicates diagnosis of new symptoms and carries higher medicolegal risk due to difficulty distinguishing anaesthesia effects from disease progression.
• Psychiatric disease or seizure disorder requiring medication within the previous 2 years.
• Opioid tolerant patient.
• Cognitive dysfunction.
• Body Mass Index ( BMI ) more than 35 kg/m2 or less than 18 kg/m2 .

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abd Elhamid

Assistant Lecturer of Anesthesia and Surgical Intensive Care , Faculty of Medicine, Alexandria University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine , Alexandria University

Alexandria, Alexandria Governorate, Egypt

Countries

Egypt

Central Contacts

Ahmed Abdelhamid Elsmany, Assistant lecturer

Role: CONTACT

ahmed.elsmany92@gmail.com

+20 01228396347

Facility Contacts

olaa mohyeldin zanaty, professor

Role: primary

ola.zanati@alexmed.edu.eg

+20 01148800811

Other Identifiers

0202188

Identifier Type: -

Identifier Source: org_study_id