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| Name | Class |
|---|---|
| Dr. Mohamed Elsayed Afandy | UNKNOWN |
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local and regional anesthesia have been introduced with the goal of reducing the side effects associated with general anesthesia and IV opioid analgesia.our hypothesis is that ultrasound-guided interscalene brachial plexus block and erector spinae plane block will provide efficient surgical anesthesia and postoperative analgesia after modified radical mastectomy.
inadequate analgesia after modified radical mastectomy with axillary lymph node dissection may occur with most of regional anesthesia. pain in the axilla and upper limb is related to ineffective block of medial and lateral pectoral nerves as long thoracic and thoracodorsal nerves, leading to inadequate analgesia.The aim of this study is to evaluate the efficacy and safety of ultrasound-guided interscalene brachial plexus block and erector spinae plane block for providing surgical anesthesia and postoperative analgesia after modified radical mastectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| regional anesthesia | Experimental | combination of erector spinae plane block (ESPB) and interscalene block(IB).the ESPB will be performed using linear ultrasound transducer (Philips® cx 50 extreme edition, USA) and we will inject 20 ml solution(10 ml 0.5% bupivacaine, 5 ml 2% lidocaine, and 5 ml normal saline). the IB will be performed using the same ultrasound machine and injecting the same solution |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| regional anesthesia | Other | combination of erector spinae plane block and interscalene block for anesthesia in modified radical mastectomy surgeries with axillary lymph node dissection |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of the regional blocks | completion of the surgery without need of general anesthesia. | from the start to the end of the operation |
| Measure | Description | Time Frame |
|---|---|---|
| duration of the blocks | Time to first request of rescue analgesia postoperative | 24- hours in the postoperative period |
| Patients' satisfaction | degree of patients' satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mona R Elghamry, MD | Tanta University, Faculty of Medicine | Principal Investigator |
| Mohamed E Afandy, MD | Tanta University, Faculty of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University, Faculty of Medicine | Tanta | 31527 | Egypt |
statistics of the age ,BMI, duration of surgery,success rate, time of first analgesic request,patients' and surgeon's satisfaction, and complications
Individual patient data will be shared after finishing and publication of the study.and it will be available for 1 year.
the individual patient data will be available for scientific research only up on email request. request will be sent to email of principal investigator (drmonagh19802000@gmail.com)
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| 24-hours postoperative |
| Any adverse events | postoperative nausea and vomiting, local anesthetic toxicity, desaturation, bradypnea,hypotension, bradycardia or somnolence | 24-hours postoperative |
| D017437 |
| Skin and Connective Tissue Diseases |