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Clinical Trials/NCT04239716
NCT04239716
Completed
Phase 3

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

Tanta University1 site in 1 country13 target enrollmentJanuary 1, 2022
ConditionsBreast Cancer

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Tanta University
Enrollment
13
Locations
1
Primary Endpoint
Success rate of the regional blocks
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
October 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mona Raafat Elghamry

Dr. Mona Raafat Elghamry Assistant Professor of anesthesiology

Tanta University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Patients' satisfaction(24-hours postoperative)
  • duration of the blocks(24- hours in the postoperative period)
  • Any adverse events(24-hours postoperative)

Study Sites (1)

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