Back to resultsUS Guided Erector Spinae Plane Block in Breast Cancer Surgery: Analgesia, Spread and Immunomodulation
Primary Purpose
Analgesia, Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Erector Spinae Plane Block with Bubivacaine
Standard General Anaesthesia
Sponsored by
About this trial
This is an interventional supportive care trial for Analgesia focused on measuring Erector spinae plane block, Ultrasound guided, Breast cancer surgery, Natural killer cells, Analgesia, spread
Eligibility Criteria
Inclusion Criteria:ASA physical status 1 or 2 scheduled for mastectomy under the effect of General Anaesthesia
-
Exclusion Criteria:
- Patient refusal.
- Allergy or contraindication to any of the studied medications or anaesthetic agents.
- Chronic opioid analgesic use.
- Pregnancy.
- Morbid obesity (BMI ≥ 40 kg/m2).
- Scoliosis or any vertebral anomalies or previous spinal surgeries.
- Infection at the site of injection or any other contraindication for regional anaesthesia.
- Duration of surgery more than 90 minutes.
- Renal impairment.
Sites / Locations
- Medical Research Institute, Alexandria University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
ESPB Bubivacaine 0.25%
ESPB Bubivacaine 0.125%
No ESPB
Arm Description
20 patients will receive US-guided deep ESPB block before induction of general anaesthesia using 20 ml bupivacaine 0.25 % and 5 ml of radiocontrast dye (Omnipaque) at the level of T4.
20 patients will receive US-guided deep ESPB block before induction of general anaesthesia using 40 ml bupivacaine 0.125 % and 5 ml of radiocontrast dye (Omnipaque) at the level of T4.
20 patients will undergo standard general anaesthesia as a control group and postoperative analgesia with intravenous morphine patient controlled analgesia (PCA) and rescue analgesia if required.
Outcomes
Primary Outcome Measures
Analgesic efficacy of ESPB
Analgesic efficacy of Erector Spinae plabe block by measuring visual analogue scale which ranges from 0 to 10. 0 indicates no pain and 10 indicates maximum imaginable pain
Secondary Outcome Measures
Spread of the injected dye in Erector Spinae plane
5 ml of radio-contrast dye will be injected in Erector Spinae plane with different dose of Bupivacaine at the level of 4th thoracic vertebra then spread of the dye will be assessed by CT scan (for example dye spread to first thoracic vertebra level cranially and 9th thoracic vertebra caudally).
3 D reconstruction of the image will be done then Craniocaudal spread of the contrast and spread to Paravertebral space, epidural space or rami of the spinal nerves will be assessed and recorded.
Dermatomal sensory coverage of ESPB
will be assessed by hyposthesia to cold sensation. Field of sensory block from T1 to T6 will be assessed bilaterally every 3 minutes for 15 minutes after deep ESPB using a piece of cotton soaked in iced water. The adequacy of sensory block T1-T6 will be determined before induction of general anaesthesia.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04796363
Brief Title
US Guided Erector Spinae Plane Block in Breast Cancer Surgery: Analgesia, Spread and Immunomodulation
Official Title
Ultrasound Guided Erector Spinae Plane Block in Breast Cancer Surgery: Analgesia, Spread and Immunomodulation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 25, 2020 (Actual)
Primary Completion Date
January 11, 2022 (Actual)
Study Completion Date
January 21, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Prospective interventional study
Detailed Description
The aim of the present study is to evaluate the effect of US guided unilateral ESPB using different volumes of local anaesthetics on analgesic efficacy, dermatomal spread and immunomodulation in breast cancer surgery.
The primary outcome is the analgesic efficacy of the different local anaesthetic volumes of ESPB.
The secondary outcomes are the dermatomal dye spread and sensory coverage, immunomodulation and complications in breast cancer surgery.
Immunomodulation will be assessed by measuring Natural killer cells cytotoxicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Breast Cancer
Keywords
Erector spinae plane block, Ultrasound guided, Breast cancer surgery, Natural killer cells, Analgesia, spread
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ESPB Bubivacaine 0.25%
Arm Type
Experimental
Arm Description
20 patients will receive US-guided deep ESPB block before induction of general anaesthesia using 20 ml bupivacaine 0.25 % and 5 ml of radiocontrast dye (Omnipaque) at the level of T4.
Arm Title
ESPB Bubivacaine 0.125%
Arm Type
Active Comparator
Arm Description
20 patients will receive US-guided deep ESPB block before induction of general anaesthesia using 40 ml bupivacaine 0.125 % and 5 ml of radiocontrast dye (Omnipaque) at the level of T4.
Arm Title
No ESPB
Arm Type
Placebo Comparator
Arm Description
20 patients will undergo standard general anaesthesia as a control group and postoperative analgesia with intravenous morphine patient controlled analgesia (PCA) and rescue analgesia if required.
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block with Bubivacaine
Intervention Description
Erector Spinae Plane Block with Bubivacaine 0.25% or 0.125% before breast cancer surgery
Intervention Type
Procedure
Intervention Name(s)
Standard General Anaesthesia
Intervention Description
Standard General Anaesthesia without ESPB
Primary Outcome Measure Information:
Title
Analgesic efficacy of ESPB
Description
Analgesic efficacy of Erector Spinae plabe block by measuring visual analogue scale which ranges from 0 to 10. 0 indicates no pain and 10 indicates maximum imaginable pain
Time Frame
Up to 24 postoperative hours
Secondary Outcome Measure Information:
Title
Spread of the injected dye in Erector Spinae plane
Description
5 ml of radio-contrast dye will be injected in Erector Spinae plane with different dose of Bupivacaine at the level of 4th thoracic vertebra then spread of the dye will be assessed by CT scan (for example dye spread to first thoracic vertebra level cranially and 9th thoracic vertebra caudally).
3 D reconstruction of the image will be done then Craniocaudal spread of the contrast and spread to Paravertebral space, epidural space or rami of the spinal nerves will be assessed and recorded.
Time Frame
Patients will be imaged 15 minutes after the block and before induction of general anaesthesia and surgery.
Title
Dermatomal sensory coverage of ESPB
Description
will be assessed by hyposthesia to cold sensation. Field of sensory block from T1 to T6 will be assessed bilaterally every 3 minutes for 15 minutes after deep ESPB using a piece of cotton soaked in iced water. The adequacy of sensory block T1-T6 will be determined before induction of general anaesthesia.
Time Frame
Assessment will be done bilaterally every 3 minutes for 15 minutes after ESPB.
Other Pre-specified Outcome Measures:
Title
Immunomodulation of ESPB
Description
Immunomodulation of ESPB by measuring Natural Killer cells cytotoxicity. Samples of 1 ml of patients' peripheral blood will be collected on EDTA for flow cytometry to enumerate for both cytotoxic lymphocyte populations (NK cells and cytotoxic t lymphocytes (Ctls)). CD 56 will be used as a marker for NK cells, while CD 8 will be used as a marker for Ctls.
Cytotoxicity assay will be done by measuring the release of lactate dehydrogenase (LDH) from cells. Then ratio of LDH released specifically from NK cells will be correlated according to the results of flow cytometry.
Time Frame
Before ESPB and 24 hours after the block.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:ASA physical status 1 or 2 scheduled for mastectomy under the effect of General Anaesthesia
-
Exclusion Criteria:
Patient refusal.
Allergy or contraindication to any of the studied medications or anaesthetic agents.
Chronic opioid analgesic use.
Pregnancy.
Morbid obesity (BMI ≥ 40 kg/m2).
Scoliosis or any vertebral anomalies or previous spinal surgeries.
Infection at the site of injection or any other contraindication for regional anaesthesia.
Duration of surgery more than 90 minutes.
Renal impairment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emad Eldin Abd El Monem Arida, Professor
Organizational Affiliation
University of Alexandria
Official's Role
Study Chair
Facility Information:
Facility Name
Medical Research Institute, Alexandria University
City
Alexandria
ZIP/Postal Code
21561
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
starting 6 months after publication
Citations:
PubMed Identifier
36253729
Citation
Abdella AMMR, Arida EEAEM, Megahed NA, El-Amrawy WZ, Mohamed WMA. Analgesia and spread of erector spinae plane block in breast cancer surgeries: a randomized controlled trial. BMC Anesthesiol. 2022 Oct 17;22(1):321. doi: 10.1186/s12871-022-01860-w.
Results Reference
derived
Learn more about this trial
US Guided Erector Spinae Plane Block in Breast Cancer Surgery: Analgesia, Spread and Immunomodulation
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