Impact of Novel Thoracic Wall Blocks With Dexmetomidine on Inflammatory Markers Following Breast Cancer Surgery

St. Elizabeth Cancer Institute, Slovakia

Status: Unknown

Conditions: Inflammatory Markers

Treatments: Procedure: Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB)

Study type: Interventional

Funder types: Other

Identifiers

NCT04860115

07-2021/EK OUSA

Details and patient eligibility

About

The study will test the hypothesis that inflammatory markers measured at 24 hours after breast cancer surgery will be lower in patients receiving PECS II and PIFB blocks, supplemented with dexmetomidine compared to standard care group.

Full description

Breast cancer is a devastating disease. Surgery is the mainstay of treatment which can lead to ongoing patient difficulties. Severe acute pain after surgery is one of major risk factors for developing persistent postsurgical pain. Subsequent physiological stress caused by this severe pain may negatively influence the immune response leading to a worse prognosis.

Regional anesthesia is very effective in management of peri- and postoperative pain. Epidural block, paravertebral block and intercostal nerve blocks have been proven over time to be effective in preventing postoperative pain. However, their widespread use has been hampered by technical difficulty and inherent risks.

Unlike the aforementioned blocks, novel thoracic wall blocks, namely modified pectoralis block (PECS II) and pecto-intercostal fascial block (PIFB) are safe, simple and effective.

Efforts to prolong and improve analgesia following single shot blocks has led to the introduction of adjuvants into the local anesthetic. Dexmetomidine is a superselective Alpha 2 agonist with a proven ability to prolong the duration of neuraxial, peripheral nerve and interfascial plane blocks.

Chronic inflammation is recognized as a risk factor for initiation, progression and further spread of malignant growth. Surgical insult leads to inflammatory response which facilitates the development of a metastatic disease. Many inflammatory markers were proven to be independent prognostic factors in breast cancer patients.

The investigators propose to study the impact of novel thoracic wall blocks with dexmetomidine on simple inflammatory markers obtained from full blood count (NLR, PLR, NPR, PDW, MPV, RDW) after breast cancer surgery.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients with ductal carcinoma (stage 1 to 3) undergoing primary potentially curative unilateral mastectomy.
• Older than 18 years
• ASA I-III

Exclusion criteria

• Weight < 50 kg
• BMI > 35
• Allergy to local anaesthetic or dexmetomidine
• Contraindications to NSAIDs use
• Local infection over block site
• Coagulopathy
• Preexisting chronic pain
• Pregnancy
• Autoimmune disease
• Inability to give informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Block group

Experimental group

Description:

Patients in a Block group will be anesthetized and receive PECS II+PIFB with dexmetomidine prior to their surgery.

Treatment:

Procedure: Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB)

Control group

No Intervention group

Description:

Patients in a Control group will receive a standard general anesthesia the same way as patients in the interventional group but without regional anesthesia.