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Prospective interventional study
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESPB Bubivacaine 0.25% | Experimental | 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. |
|
| ESPB Bubivacaine 0.125% | Active Comparator | 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. |
|
| No ESPB | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector Spinae Plane Block with Bubivacaine | Procedure | Erector Spinae Plane Block with Bubivacaine 0.25% or 0.125% before breast cancer surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 24 postoperative hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunomodulation of ESPB | 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. |
Inclusion Criteria:ASA physical status 1 or 2 scheduled for mastectomy under the effect of General Anaesthesia
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emad Eldin Abd El Monem Arida, Professor | University of Alexandria | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Research Institute, Alexandria University | Alexandria | 21561 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36253729 | Derived | 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. |
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All IPD that underlie results in a publication
starting 6 months after publication
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 15, 2022 | |
| Reset | Jan 13, 2023 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 23, 2020 | Mar 9, 2021 | Prot_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 15, 2022 | Jan 13, 2023 |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Standard General Anaesthesia | Procedure | Standard General Anaesthesia without ESPB |
|
| Patients will be imaged 15 minutes after the block and before induction of general anaesthesia and surgery. |
| 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. | Assessment will be done bilaterally every 3 minutes for 15 minutes after ESPB. |
| Before ESPB and 24 hours after the block. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |