US Guided Erector Spinae Plane Block in Breast Cancer Surgery: Analgesia, Spread and Immunomodulation
NCT ID: NCT04796363
Last Updated: 2022-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2020-11-25
2022-01-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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ESPB Bubivacaine 0.25%
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.
Erector Spinae Plane Block with Bubivacaine
Erector Spinae Plane Block with Bubivacaine 0.25% or 0.125% before breast cancer surgery
ESPB Bubivacaine 0.125%
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.
Erector Spinae Plane Block with Bubivacaine
Erector Spinae Plane Block with Bubivacaine 0.25% or 0.125% before breast cancer surgery
No ESPB
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.
Standard General Anaesthesia
Standard General Anaesthesia without ESPB
Interventions
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Erector Spinae Plane Block with Bubivacaine
Erector Spinae Plane Block with Bubivacaine 0.25% or 0.125% before breast cancer surgery
Standard General Anaesthesia
Standard General Anaesthesia without ESPB
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Allergy or contraindication to any of the studied medications or anaesthetic agents.
3. Chronic opioid analgesic use.
4. Pregnancy.
5. Morbid obesity (BMI ≥ 40 kg/m2).
6. Scoliosis or any vertebral anomalies or previous spinal surgeries.
7. Infection at the site of injection or any other contraindication for regional anaesthesia.
8. Duration of surgery more than 90 minutes.
9. Renal impairment.
20 Years
50 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Responsible Party
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Ahmed Mohamed Mohamed Rabah Abdella
Principal investigator
Principal Investigators
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Emad Eldin Abd El Monem Arida, Professor
Role: STUDY_CHAIR
University of Alexandria
Locations
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Medical Research Institute, Alexandria University
Alexandria, , Egypt
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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Medical Research Institute
Identifier Type: -
Identifier Source: org_study_id
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