NCT04860115

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: St. Elizabeth Cancer Institute, Slovakia · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inflammatory Markers

Interventions

Type	Name	Description
PROCEDURE	Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB)	PECS II: Ultrasound guided block involving injection of 20 ml of 0.25% L-bupivacaine with dexmetomidine into an interfascial plane between the serratus anterior muscle and the external intercostal muscles followed by the needle withdrawal into an interfascial plane between the pectoralis major and pectoralis minor muscle where further 10ml will be administered. PIFB: Ultrasound guided block involving injection of 10 ml of 0.25% L-bupivacaine with dexmetomidine into an iterfascial plane between the pectoralis major and the intercostal muscles approximately 2 cm laterally from the sternum to cover T2 to T6 dermatomes.

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-11-01
• Completion: 2023-12-01
• First posted: 2021-04-26
• Last updated: 2021-09-28