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Clinical Trials/NCT04702061
NCT04702061
Completed
Not Applicable

Comparison of Erector Spina Plane Block and Thoracic Epidural Block in Breast Surgery

Inonu University1 site in 1 country20 target enrollmentJanuary 11, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Neoplasms
Sponsor
Inonu University
Enrollment
20
Locations
1
Primary Endpoint
Sympathetic block level evaluation by hemodynamic data
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The aim of this randomised controlled and double-blind study, is to compare the effects of erector spinae plane (ESP) and thoracic epidural (TEA) blocks on peri-operative hemodynamics and analgesia in patients undergoing unilateral mastectomies due to malignancy.

Detailed Description

Patients will be randomised into two groups as Group E (those who received general anesthesia after the erector spina plan block) and Group T (those who received general anesthesia after thoracic epidural block). After the block skin conductivity (galvanic skin response - GSR), body temperature changes, sympathetic and sensory block levels, peri-operative hemodynamic data, postoperative pain scores and analgesic consumption will be recorded.

Registry
clinicaltrials.gov
Start Date
January 11, 2021
End Date
March 31, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gulay ERDOGAN KAYHAN

Professor, MD

Inonu University

Eligibility Criteria

Inclusion Criteria

  • ASA(American Society of Anesthesiologist) physical classification I-III
  • Patients undergoing unilateral mastectomies due to malignancy

Exclusion Criteria

  • Active infection at the intervention site
  • History of coagulopathy or anticoagulant use (less time has passed before peripheral and central blocks)
  • Major cardiac, pulmonary, renal and neurological diseases
  • Autonomic neuropathy or use of drugs that affect autonomic function
  • Patients with type 1 diabetes or insulin dependent type 2 diabetes over 10 years
  • Allergic to local anesthetics;
  • Patients who are uncooperative or have psychiatric problems
  • Morbidly obese (body mass index \> 35 kg/m2)

Outcomes

Primary Outcomes

Sympathetic block level evaluation by hemodynamic data

Time Frame: 45 minutes after block administration

Peri-operative heart rate and mean arterial pressure will be recorded

Sensorial block level evaluation

Time Frame: 45 minutes after block administration

By pin-prick test

Sympathetic block level evaluation with skin temperature

Time Frame: 45 minutes after block administration

Skin temperature of bilateral thorax will be measured

Sympathetic block level evaluation with skin conductivity

Time Frame: 45 minutes after block administration

Skin conductivity will be measured by galvanic skin response (GSR)

Sympathetic block level evaluation with hot cold test

Time Frame: 45 minutes after block administration

Hot cold test of bilateral thorax will be measured

Secondary Outcomes

  • Postoperative pain scores(24 hours after operation)
  • intraoperative hemodynamic data(During the operation)
  • Rescue analgesics consumption(24 hours after operation)

Study Sites (1)

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