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Inflammatory MarkersNCT04860115

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

A study testing Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB) in people with Inflammatory Markers, run by St. Elizabeth Cancer Institute, Slovakia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Inflammatory Markers
What is being tested?
Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
1 Nov 2021to 1 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Weight < 50 kg
  • BMI > 35
  • Allergy to local anaesthetic or dexmetomidine
  • Contraindications to NSAIDs use
  • Local infection over block site
  • Coagulopathy
Show all 10Show fewer
  • Preexisting chronic pain
  • Pregnancy
  • Autoimmune disease
  • Inability to give informed consent

Trial locations and contacts

No sites are listed yet.

Tomas Hitka, MD contact

00421902753979

hitka@yahoo.com

Roman Zahorec, MD contact

00421 2 32249210

roman.zahorec@ousa.sk

About this study

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.

Read the 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.

Being tested
Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB)
Keywords
PEC II, PIFB, breast cancer, NLR
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB)Procedure or surgery

    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.

Study groups in NCT04860115
Study groupRoleWhat they receive
Block groupExperimentalPatients in a Block group will be anesthetized and receive PECS II+PIFB with dexmetomidine prior to their surgery.
Receives: Procedure: Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB)
Control groupNo interventionPatients in a Control group will receive a standard general anesthesia the same way as patients in the interventional group but without regional anesthesia.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 hours after surgery

Secondary outcomes (4)

  1. Markers of inflammation

    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

    Measured: 24 hours after surgery

  2. Intraoperative opioids

    Intraoperative consumption of opioids

    Measured: Duration of surgery

  3. 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

    Measured: 1,6,12,18,24 hours after surgery

  4. Opioid consumption

    Total opioid consumption after surgery at 24 h

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2021
  2. Study start1 Nov 2021 (estimated)
  3. Primary completion1 Nov 2023 (estimated)
  4. Study completion1 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
120 patients randomized into two groups of 60 patients. Group B (PECS II+PIFB with dexmetomidine) and Group C (control).
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04860115
Sponsor's protocol ID
07-2021/EK OUSA
Status last verified
Sep 2021
First submitted
21 Apr 2021
Last updated
28 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26742998

  • 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.

    PubMed 19453965

  • 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.

    PubMed 21435953

  • 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.

    PubMed 25721153

  • 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. No abstract available.

    PubMed 27648890

  • 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.

    PubMed 22058144

  • Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. doi: 10.1097/00000539-200006000-00026.

    PubMed 10825328

  • 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.

    PubMed 16573313

  • 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.

    PubMed 22939099

  • de la Torre PA, Garcia PD, Alvarez SL, Miguel FJ, Perez 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. No abstract available.

    PubMed 24396082

  • 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.

    PubMed 27543533

  • 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.

    PubMed 27258154

  • 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.

    PubMed 24317234

  • 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.

    PubMed 28528536

  • 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.

    PubMed 21376230

Questions about this trial

What is this clinical trial studying?

A study testing Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB) in people with Inflammatory Markers, run by St. Elizabeth Cancer Institute, Slovakia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tomas Hitka, MD (00421902753979, hitka@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in NLR (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04860115, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.

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