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Regional Anesthesia for Modified Radical Mastectomy With Axillary Lymph Node Dissection

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04239716
Enrollment
13
Registered
2020-01-27
Start date
2022-01-01
Completion date
2022-10-31
Last updated
2023-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief 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.

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.

Interventions

OTHERregional anesthesia

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

Sponsors

Dr. Mohamed Elsayed Afandy
CollaboratorUNKNOWN
Tanta University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Success rate of the regional blocksfrom the start to the end of the operationcompletion of the surgery without need of general anesthesia.

Secondary

MeasureTime frameDescription
duration of the blocks24- hours in the postoperative periodTime to first request of rescue analgesia postoperative
Patients' satisfaction24-hours postoperativedegree of patients' satisfaction
Any adverse events24-hours postoperativepostoperative nausea and vomiting, local anesthetic toxicity, desaturation, bradypnea,hypotension, bradycardia or somnolence

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026