Impact of Novel Thoracic Wall Blocks With Dexmetomidine on Inflammatory Markers Following Breast Cancer Surgery
Primary Purpose
Inflammatory Markers
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB)
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Markers focused on measuring PEC II, PIFB, breast cancer, NLR
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Block group
Control group
Arm Description
Patients in a Block group will be anesthetized and receive PECS II+PIFB with dexmetomidine prior to their surgery.
Patients in a Control group will receive a standard general anesthesia the same way as patients in the interventional group but without regional anesthesia.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Intraoperative opioids
Intraoperative consumption of opioids
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
Opioid consumption
Total opioid consumption after surgery at 24 h
Full Information
NCT ID
NCT04860115
First Posted
April 21, 2021
Last Updated
September 27, 2021
Sponsor
St. Elizabeth Cancer Institute, Slovakia
Collaborators
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica, Louis Pasteur University Hospital Kosice
1. Study Identification
Unique Protocol Identification Number
NCT04860115
Brief Title
Impact of Novel Thoracic Wall Blocks With Dexmetomidine on Inflammatory Markers Following Breast Cancer Surgery
Official Title
Impact of Novel Thoracic Wall Blocks With Dexmetomidine on Inflammatory Markers Following Breast Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Elizabeth Cancer Institute, Slovakia
Collaborators
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica, Louis Pasteur University Hospital Kosice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Markers
Keywords
PEC II, PIFB, breast cancer, NLR
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
120 patients randomized into two groups of 60 patients. Group B (PECS II+PIFB with dexmetomidine) and Group C (control).
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Block group
Arm Type
Experimental
Arm Description
Patients in a Block group will be anesthetized and receive PECS II+PIFB with dexmetomidine prior to their surgery.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in a Control group will receive a standard general anesthesia the same way as patients in the interventional group but without regional anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in NLR
Description
Difference in neutrophil-lymphocyte ratio (NLR) between the intervention group and the standard care group measured at 24 hours after breast cancer surgery
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Markers of inflammation
Description
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
Time Frame
24 hours after surgery
Title
Intraoperative opioids
Description
Intraoperative consumption of opioids
Time Frame
Duration of surgery
Title
Pain after surgery
Description
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
Time Frame
1,6,12,18,24 hours after surgery
Title
Opioid consumption
Description
Total opioid consumption after surgery at 24 h
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Adverse effects
Description
Incidence of potential adverse effects
Time Frame
24 hours
Title
Postsurgical pain
Description
Incidence of postsurgical pain at 1month, 2month and 3 months
Time Frame
3 months after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tomas Hitka, MD
Phone
00421902753979
Email
hitka@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Roman Zahorec, MD
Phone
00421 2 32249210
Email
roman.zahorec@ousa.sk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomas Hitka, MD
Organizational Affiliation
St. Elizabeth Cancer Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Novel Thoracic Wall Blocks With Dexmetomidine on Inflammatory Markers Following Breast Cancer Surgery
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