Impact of Novel Thoracic Wall Blocks With Dexmetomidine on Inflammatory Markers Following Breast Cancer Surgery
- Conditions
- Inflammatory Markers
- Interventions
- Procedure: Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB)
- Registration Number
- NCT04860115
- Lead Sponsor
- St. Elizabeth Cancer Institute, Slovakia
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 120
- Female patients with ductal carcinoma (stage 1 to 3) undergoing primary potentially curative unilateral mastectomy.
- Older than 18 years
- ASA I-III
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Block group Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB) Patients in a Block group will be anesthetized and receive PECS II+PIFB with dexmetomidine prior to their surgery.
- Primary Outcome Measures
Name Time Method Difference in NLR 24 hours after surgery Difference in neutrophil-lymphocyte ratio (NLR) between the intervention group and the standard care group measured at 24 hours after breast cancer surgery
- Secondary Outcome Measures
Name Time Method Intraoperative opioids Duration of surgery Intraoperative consumption of opioids
Pain after surgery 1,6,12,18,24 hours after surgery Numeric rating scale for pain (NRS, 0-10, where 0 means no pain and 10 the worst pain) at 0, 1h, 6h, 12h,18h,24h after surgery at rest and at ipsilateral arm abduction
Markers of inflammation 24 hours after surgery Difference in Δ NLR, PLR, NPR, PDW, MPV and RDW between the intervention group and the standard care group measured at 24 hours after breast cancer surgery
Opioid consumption 24 hours Total opioid consumption after surgery at 24 h