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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: regional anesthesia

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 31527
    • Tanta University, Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	24-hours postoperative
Any adverse events	postoperative nausea and vomiting, local anesthetic toxicity, desaturation, bradypnea,hypotension, bradycardia or somnolence	24-hours postoperative

Collaborators and Investigators

• Sponsor: Tanta University
• Collaborators: Dr. Mohamed Elsayed Afandy
• Investigators: Principal Investigator: Mona R Elghamry, MD, Tanta University, Faculty of Medicine; Study Director: Mohamed E Afandy, MD, Tanta University, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: January 18, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: mastectomy regional anesthesia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: statistics of the age ,BMI, duration of surgery,success rate, time of first analgesic request,patients' and surgeon's satisfaction, and complications
• IPD Sharing Time Frame: Individual patient data will be shared after finishing and publication of the study.and it will be available for 1 year.
• IPD Sharing Access Criteria: 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)
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes