Skip to main content
OpenTrials
Completed

NCT Number: NCT04239716

Regional Anesthesia for Modified Radical Mastectomy With Axillary Lymph Node Dissection

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

40 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Tanta University, Faculty of Medicine

Tanta, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Regional anesthesia

Other

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

Primary outcomes

  1. Success rate of the regional blocks

    Time frame: from the start to the end of the operation

    completion of the surgery without need of general anesthesia.

Secondary outcomes

  1. duration of the blocks

    Time frame: 24- hours in the postoperative period

    Time to first request of rescue analgesia postoperative

  2. Patients' satisfaction

    Time frame: 24-hours postoperative

    degree of patients' satisfaction

  3. Any adverse events

    Time frame: 24-hours postoperative

    postoperative nausea and vomiting, local anesthetic toxicity, desaturation, bradypnea,hypotension, bradycardia or somnolence

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Collaborators

  • Dr. Mohamed Elsayed Afandy

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2020
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.