Regional Anesthesia for Modified Radical Mastectomy With Axillary Lymph Node Dissection

NCT04239716 — Phase 3, Completed, 13 participants, Tanta University

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Feasibility of Combined Ultrasound Guided Interscalene Brachial Plexus Block and Erector Spinae Plane Block for Anesthesia in Modified Radical Mastectomy With Axillary Lymph Node Dissection: Pilot Study

Registry	NCT04239716
Status	Completed
Phase	Phase 3
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	13 (Actual)
Sponsor	Tanta University (Other); collaborators: Dr. Mohamed Elsayed Afandy
Conditions	Breast Cancer
Interventions	regional anesthesia (Other)
Dates	start 2022-01-01, primary completion 2022-10-31, completion 2022-10-31, first posted 2020-01-27, last updated 2023-11-30
Locations	1 site in Egypt

-Summary

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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
regional anesthesia	Experimental	Other: regional anesthesia	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

regional anesthesia (Other): combination of erector spinae plane block and interscalene block for anesthesia in modified radical mastectomy surgeries with axillary lymph node dissection

+Outcome measures

Primary outcomes

Success rate of the regional blocks [from the start to the end of the operation]: completion of the surgery without need of general anesthesia.

Secondary outcomes

duration of the blocks [24- hours in the postoperative period]: Time to first request of rescue analgesia postoperative
Patients' satisfaction [24-hours postoperative]: degree of patients' satisfaction
Any adverse events [24-hours postoperative]: postoperative nausea and vomiting, local anesthetic toxicity, desaturation, bradypnea,hypotension, bradycardia or somnolence

+Eligibility

Sex: Female, ages: 40 Years to 85 Years

Inclusion Criteria:

* Female patients aged 40-85 years old
* American Society of Anesthesiologists' physical status III and IV
* Planned for modified radical mastectomy with axillary lymph node dissection

Exclusion Criteria:

* Patient refusal
* Neurological or psychiatric disorders
* Local infection at injection site
* Spine or chest wall deformity
* Allergy or any contraindication to any of the study drugs
* Opioid or alcoholic addiction
* Chronic pain of any cause
* Uncooperative patients.

+Locations (1)

Facility	City	Country	Status
Tanta University, Faculty of Medicine	Tanta	Egypt

+Investigators

Mona R Elghamry, MD, Principal investigator, Tanta University, Faculty of Medicine
Mohamed E Afandy, MD, Study director, Tanta University, Faculty of Medicine