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

Inflammatory Markers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04860115
• Other study ID #: 07-2021/EK OUSA
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: September 2021
• Source: St. Elizabeth Cancer Institute, Slovakia
• Contact: Tomas Hitka, MD
• Phone: 00421902753979
• Email: hitka[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Inflammatory Markers

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
St. Elizabeth Cancer Institute, Slovakia	F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica, Louis Pasteur University Hospital Kosice

References & Publications (19)

Andersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24. Review. — View Citation

Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29. — View Citation

de la Torre PA, García PD, Alvarez SL, Miguel FJ, Pérez MF. A novel ultrasound-guided block: a promising alternative for breast analgesia. Aesthet Surg J. 2014 Jan 1;34(1):198-200. doi: 10.1177/1090820X13515902. — View Citation

Duff S, Connolly C, Buggy DJ. Adrenergic, Inflammatory, and Immune Function in the Setting of Oncological Surgery: Their Effects on Cancer Progression and the Role of the Anesthetic Technique in their Modulation. Int Anesthesiol Clin. 2016 Fall;54(4):48-57. doi: 10.1097/AIA.0000000000000120. Review. — View Citation

Fecho K, Miller NR, Merritt SA, Klauber-Demore N, Hultman CS, Blau WS. Acute and persistent postoperative pain after breast surgery. Pain Med. 2009 May-Jun;10(4):708-15. doi: 10.1111/j.1526-4637.2009.00611.x. Epub 2009 Apr 22. — View Citation

Freise H, Van Aken HK. Risks and benefits of thoracic epidural anaesthesia. Br J Anaesth. 2011 Dec;107(6):859-68. doi: 10.1093/bja/aer339. Epub 2011 Nov 4. Review. — View Citation

Fritsch G, Danninger T, Allerberger K, Tsodikov A, Felder TK, Kapeller M, Gerner P, Brummett CM. Dexmedetomidine added to ropivacaine extends the duration of interscalene brachial plexus blocks for elective shoulder surgery when compared with ropivacaine alone: a single-center, prospective, triple-blind, randomized controlled trial. Reg Anesth Pain Med. 2014 Jan-Feb;39(1):37-47. doi: 10.1097/AAP.0000000000000033. — View Citation

Hanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell. 2011 Mar 4;144(5):646-74. doi: 10.1016/j.cell.2011.02.013. Review. — View Citation

Hu L, Li M, Ding Y, Pu L, Liu J, Xie J, Cabanero M, Li J, Xiang R, Xiong S. Prognostic value of RDW in cancers: a systematic review and meta-analysis. Oncotarget. 2017 Feb 28;8(9):16027-16035. doi: 10.18632/oncotarget.13784. Review. — View Citation

Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. — View Citation

Koh CH, Bhoo-Pathy N, Ng KL, Jabir RS, Tan GH, See MH, Jamaris S, Taib NA. Utility of pre-treatment neutrophil-lymphocyte ratio and platelet-lymphocyte ratio as prognostic factors in breast cancer. Br J Cancer. 2015 Jun 30;113(1):150-8. doi: 10.1038/bjc.2015.183. Epub 2015 May 28. — View Citation

Kolawole IK, Adesina MD, Olaoye IO. Intercostal nerves block for mastectomy in two patients with advanced breast malignancy. J Natl Med Assoc. 2006 Mar;98(3):450-3. — View Citation

Krenn-Pilko S, Langsenlehner U, Thurner EM, Stojakovic T, Pichler M, Gerger A, Kapp KS, Langsenlehner T. The elevated preoperative platelet-to-lymphocyte ratio predicts poor prognosis in breast cancer patients. Br J Cancer. 2014 May 13;110(10):2524-30. doi: 10.1038/bjc.2014.163. Epub 2014 Mar 27. — View Citation

Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223. — View Citation

Lee SK, Choi MY, Bae SY, Lee JH, Lee HC, Kil WH, Lee JE, Kim SW, Nam SJ. Immediate postoperative inflammation is an important prognostic factor in breast cancer. Oncology. 2015;88(6):337-44. doi: 10.1159/000368985. Epub 2015 Feb 25. — View Citation

Marhofer P, Brummett CM. Safety and efficiency of dexmedetomidine as adjuvant to local anesthetics. Curr Opin Anaesthesiol. 2016 Oct;29(5):632-7. doi: 10.1097/ACO.0000000000000364. Review. — View Citation

Ní Eochagáin A, Burns D, Riedel B, Sessler DI, Buggy DJ. The effect of anaesthetic technique during primary breast cancer surgery on neutrophil-lymphocyte ratio, platelet-lymphocyte ratio and return to intended oncological therapy. Anaesthesia. 2018 May;7 — View Citation

Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7. — View Citation

Xu L, Hu Z, Shen J, McQuillan PM. Efficacy of US-guided transversus abdominis plane block and rectus sheath block with ropivacaine and dexmedetomidine in elderly high-risk patients. Minerva Anestesiol. 2018 Jan;84(1):18-24. doi: 10.23736/S0375-9393.17.11538-5. Epub 2017 May 19. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse effects	Incidence of potential adverse effects	24 hours
Other	Postsurgical pain	Incidence of postsurgical pain at 1month, 2month and 3 months	3 months after surgery
Primary	Difference in NLR	Difference in neutrophil-lymphocyte ratio (NLR) between the intervention group and the standard care group measured at 24 hours after breast cancer surgery	24 hours after surgery
Secondary	Markers of inflammation	Difference in ? NLR, PLR, NPR, PDW, MPV and RDW between the intervention group and the standard care group measured at 24 hours after breast cancer surgery	24 hours after surgery
Secondary	Intraoperative opioids	Intraoperative consumption of opioids	Duration of surgery
Secondary	Pain 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	1,6,12,18,24 hours after surgery
Secondary	Opioid consumption	Total opioid consumption after surgery at 24 h	24 hours