Regional Anesthesia for Modified Radical Mastectomy With Axillary Lymph Node Dissection

NCT04239716 | Completed Phase 3 DMC

• 1 other identifier: mastectomy regional anesthesia
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• duration of the blocks

  24- hours in the postoperative period

• Patients' satisfaction

  24-hours postoperative

• Any adverse events

  24-hours postoperative

Study Arms (1)

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

Other: regional anesthesia

Interventions

regional anesthesia OTHER

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

regional anesthesia

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead
• Dr. Mohamed Elsayed Afandy: collaborator

Study Sites (1)

Tanta University, Faculty of Medicine

Tanta, 31527, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Mona R Elghamry, MD

  Tanta University, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• Mohamed E Afandy, MD

  Tanta University, Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Mona Raafat Elghamry Assistant Professor of anesthesiology

Study Record Dates

• First Submitted: January 18, 2020
• First Posted: January 27, 2020
• Study Start: January 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Individual patient data will be shared after finishing and publication of the study.and it will be available for 1 year.
• 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)

Locations

EG (1)