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

NCT07108959 | Not Yet Recruiting

• 1 other identifier: 0202188
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; ESPB; Lidocaine Infusion

Keywords

breast cancer; ESPB; lidocaine infusion; cytokines

Outcome Measures

Primary Outcomes (1)

• Measuring serum pro-inflammatory cytokines (IL-1, IL-6) levels in pg/ml.

  by ELISA TECHNIQUE unit pg/ml.

  BASELINE, 2 HOURS POSTOPERATIVE AND 24 HOURS POSTOPERATIVE

Secondary Outcomes (8)

• Effect on perioperative Heart rate

  24 hours

• Effect on perioperative blood pressure

  24 hours

• post-operative pain.

  24 hours

• Duration of postoperative analgesia (min).

  24 hours

• Perioperative analgesic consumptions.

  24 hours

Study Arms (2)

Group E

ACTIVE COMPARATOR

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

Procedure: Erector spinae plane block (Group E)

Group L

ACTIVE COMPARATOR

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.

Procedure: Lidocaine (drug)

Interventions

Erector spinae plane block (Group E) 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 E

Lidocaine (drug) 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.

Group L

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Medicine , Alexandria University

Alexandria, Alexandria Governorate, 21526, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Lidocaine; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Ahmed Abdelhamid Elsmany, Assistant lecturer

CONTACT

+20 01228396347; ahmed.elsmany92@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesia and Surgical Intensive Care , Faculty of Medicine, Alexandria University

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: August 7, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)