Regional Anesthesia for Modified Radical Mastectomy With Axillary Lymph Node Dissection

Breast Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04239716
• Other study ID #: mastectomy regional anesthesia
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Locations

Country	Name	City	State
Egypt	Tanta University, Faculty of Medicine	Tanta

Sponsors (2)

Lead Sponsor	Collaborator
Tanta University	Dr. Mohamed Elsayed Afandy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	duration of the blocks	Time to first request of rescue analgesia postoperative	24- hours in the postoperative period
Secondary	Patients' satisfaction	degree of patients' satisfaction	24-hours postoperative
Secondary	Any adverse events	postoperative nausea and vomiting, local anesthetic toxicity, desaturation, bradypnea,hypotension, bradycardia or somnolence	24-hours postoperative