Clinical trial NCT04860115: Impact of Novel Thoracic Wall Blocks With Dexmetomidine on Inflammatory Markers Following Breast Cancer Surgery
Official title: Impact of Novel Thoracic Wall Blocks With Dexmetomidine on Inflammatory Markers Following Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Markers
Keywords: PEC II
PIFB
breast cancer
NLR
Lead sponsor: St. Elizabeth Cancer Institute, Slovakia
Sponsor class: OTHER
Collaborators: name: F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
name: Louis Pasteur University Hospital Kosice
First posted: 2021-04-26
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 120 patients randomized into two groups of 60 patients. Group B (PECS II+PIFB with dexmetomidine) and Group C (control).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in NLR
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Markers of inflammation
timeFrame: 24 hours after surgery
measure: Intraoperative opioids
timeFrame: Duration of surgery
measure: Pain after surgery
timeFrame: 1,6,12,18,24 hours after surgery
measure: Opioid consumption
timeFrame: 24 hours
Other outcomes:
measure: Adverse effects
timeFrame: 24 hours
measure: Postsurgical pain
timeFrame: 3 months after surgery
Locations:
Study officials:
affiliation: St. Elizabeth Cancer Institute
name: Tomas Hitka, MD
role: PRINCIPAL_INVESTIGATOR
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