AzTrials
AzTrials

Breast CancerESPBNCT07108959

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

A study testing Erector spinae plane block (Group E) and Lidocaine (drug) in people with Breast Cancer and ESPB, run by Alexandria University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 30 to 60 years, women only
Conditions the study is for
Breast Cancer, ESPB, Lidocaine Infusion
What is being tested?
Erector spinae plane block (Group E) and Lidocaine (drug)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
30 Aug 2025to 28 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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 .

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Medicine , Alexandria University

    Alexandria, Alexandria Governorate, 21526

Other trials in Egypt

About this study

Official title: Effect of Ultrasound Guided Erector Spinae Plane Block Versus Perioperative Intravenous Lidocaine Infusion on Proinflammatory Cytokines in Breast Cancer Surgeries

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

Read the 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.

Being tested
Erector spinae plane block (Group E), Lidocaine (drug)
Keywords
breast cancer, ESPB, lidocaine infusion, cytokines
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erector spinae plane block (Group E)Procedure or surgery

    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.

  • Lidocaine (drug)Procedure or surgery

    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.

Study groups in NCT07108959
Study groupRoleWhat they receive
Group EActive comparatorpatients will receive ultrasound guided ESPB with 30 ml bupivacaine 0.25%.
Receives: Procedure: Erector spinae plane block (Group E)
Group LActive comparatorPatients 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.
Receives: Procedure: Lidocaine (drug)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    by ELISA TECHNIQUE unit pg/ml.

    Measured: BASELINE, 2 HOURS POSTOPERATIVE AND 24 HOURS POSTOPERATIVE

Secondary outcomes (8)
  1. Effect on perioperative Heart rate

    heart rate in beats/min

    Measured: 24 hours

  2. Effect on perioperative blood pressure

    blood pressure in mmhg

    Measured: 24 hours

  3. post-operative pain.

    by Visual Analogue Scale ( VAS Scale) score from 0 to 10 , 0 means no pain, 10 means the worst pain

    Measured: 24 hours

  4. Duration of postoperative analgesia (min).

    time for first rescue analgesia if VAS >4, by Visual Analogue Scale ( VAS Scale) score from 0 to 10 , 0 means no pain, 10 means the worst pain

    Measured: 24 hours

  5. Perioperative analgesic consumptions.

    intraoperative fentanyl in ug and postoperative morphine mg

    Measured: 24 hours

  6. Chronic postsurgical neuropathic pain

    by Douleur Neuropathique 4 (DN4 score) from 0 to 10, 0 the minimum, 10 the maximum, > 4 means high probability of neuropathic pain

    Measured: 3 months

  7. Time to return of bowel function

    time to first pass flatus and to first defecation in hours reported by the patient (physiological parameter)

    Measured: 24 hours

  8. side effects

    like Bradycardia or tachycardia, hallucination or signs of lidocaine toxicity such as circumoral numbness, tinnitus, anxiety, headache, seizure activity, and arrhythmias.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2025
  2. Study start30 Aug 2025
  3. Primary completion28 Jan 2026
  4. Study completion28 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07108959
Sponsor's protocol ID
0202188
Acronym
ESPB
Status last verified
Jun 2026
First submitted
19 Jun 2025
Last updated
15 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: practical and resource barriers

Questions about this trial

What is this clinical trial studying?

A study testing Erector spinae plane block (Group E) and Lidocaine (drug) in people with Breast Cancer and ESPB, run by Alexandria University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measuring serum pro-inflammatory cytokines (IL-1, IL-6) levels in pg/ml. (time frame: BASELINE, 2 HOURS POSTOPERATIVE AND 24 HOURS POSTOPERATIVE). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in