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

NCT04860115 | Unknown

• 1 other identifier: 07-2021/EK OUSA
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inflammatory Markers

Keywords

PEC II; PIFB; breast cancer; NLR

Outcome Measures

Primary Outcomes (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

  24 hours after surgery

Secondary Outcomes (4)

• Markers of inflammation

  24 hours after surgery

• Intraoperative opioids

  Duration of surgery

• Pain after surgery

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

• Opioid consumption

  24 hours

Other Outcomes (2)

• Adverse effects

  24 hours

• Postsurgical pain

  3 months after surgery

Study Arms (2)

Block group

EXPERIMENTAL

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)

Control group

NO INTERVENTION

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

Interventions

Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB) PROCEDURE

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.

Block group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

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  PMID: 29457215 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tomas Hitka, MD

  St. Elizabeth Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomas Hitka, MD

CONTACT

00421902753979; hitka@yahoo.com

Roman Zahorec, MD

CONTACT

00421 2 32249210; roman.zahorec@ousa.sk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 120 patients randomized into two groups of 60 patients. Group B (PECS II+PIFB with dexmetomidine) and Group C (control).

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 26, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share