Regional Anesthesia for Modified Radical Mastectomy With Axillary Lymph Node Dissection

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Other: regional anesthesia

• Registration Number: NCT04239716
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study First Submitted: 2020-01-18
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-27
• Study Start: 2022-01-01
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
regional anesthesia	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

Primary Outcome Measures

Name	Time	Method
Success rate of the regional blocks	from the start to the end of the operation	completion of the surgery without need of general anesthesia.

Secondary Outcome Measures

Name	Time	Method
Patients' satisfaction	24-hours postoperative	degree of patients' satisfaction
duration of the blocks	24- hours in the postoperative period	Time to first request of rescue analgesia postoperative
Any adverse events	24-hours postoperative	postoperative nausea and vomiting, local anesthetic toxicity, desaturation, bradypnea,hypotension, bradycardia or somnolence

Trial Locations

Locations (1)

Tanta University, Faculty of Medicine; 🇪🇬 Tanta, Egypt