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

Sponsor
St. Elizabeth Cancer Institute, Slovakia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04860115
Collaborator
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica (Other), Louis Pasteur University Hospital Kosice (Other)
120
2
25

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB)
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
120 patients randomized into two groups of 60 patients. Group B (PECS II+PIFB with dexmetomidine) and Group C (control).120 patients randomized into two groups of 60 patients. Group B (PECS II+PIFB with dexmetomidine) and Group C (control).
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Intervention will be done under general anesthesia so participant will be blinded and primary outcome which will be laboratory test will be assessed by a person not aware of intervention.
Primary Purpose:
Treatment
Official Title:
Impact of Novel Thoracic Wall Blocks With Dexmetomidine on Inflammatory Markers Following Breast Cancer Surgery
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Block group

Patients in a Block group will be anesthetized and receive PECS II+PIFB with dexmetomidine prior to their surgery.

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.

No Intervention: Control group

Patients in a Control group will receive a standard general anesthesia the same way as patients in the interventional group but without regional anesthesia.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. Intraoperative opioids [Duration of surgery]

    Intraoperative consumption of opioids

  3. 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

  4. Opioid consumption [24 hours]

    Total opioid consumption after surgery at 24 h

Other Outcome Measures

  1. Adverse effects [24 hours]

    Incidence of potential adverse effects

  2. Postsurgical pain [3 months after surgery]

    Incidence of postsurgical pain at 1month, 2month and 3 months

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Tomas Hitka, MD, St. Elizabeth Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
St. Elizabeth Cancer Institute, Slovakia
ClinicalTrials.gov Identifier:
NCT04860115
Other Study ID Numbers:
  • 07-2021/EK OUSA
First Posted:
Apr 26, 2021
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by St. Elizabeth Cancer Institute, Slovakia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2021