Comparison of Erector Spina Plane Block and Thoracic Epidural Block

Not Applicable

Completed

• Conditions: Breast Neoplasms; Pain, Postoperative
• Interventions: Other: Thoracic epidural block before general anaesthesia; Other: Erector spina plane block before general anaesthesia

• Registration Number: NCT04702061
• Lead Sponsor: Inonu University

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.

Study Timeline

• Study First Submitted: 2020-12-24
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-08
• Study Start: 2021-01-11
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-19
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group T	Thoracic epidural block before general anaesthesia	Patients who receive general anesthesia after thoracic epidural block
Group E	Erector spina plane block before general anaesthesia	Patients who receive general anesthesia after erector spina plane block

Primary Outcome Measures

Name	Time	Method
Sympathetic block level evaluation by hemodynamic data	45 minutes after block administration	Peri-operative heart rate and mean arterial pressure will be recorded
Sensorial block level evaluation	45 minutes after block administration	By pin-prick test
Sympathetic block level evaluation with skin temperature	45 minutes after block administration	Skin temperature of bilateral thorax will be measured
Sympathetic block level evaluation with skin conductivity	45 minutes after block administration	Skin conductivity will be measured by galvanic skin response (GSR)
Sympathetic block level evaluation with hot cold test	45 minutes after block administration	Hot cold test of bilateral thorax will be measured

Secondary Outcome Measures

Name	Time	Method
Postoperative pain scores	24 hours after operation	Pain score will be measured with visual analog scale (0-no pain; 10-worst pain) during movement and rest.
intraoperative hemodynamic data	During the operation	Heart rate and mean arterial pressure
Rescue analgesics consumption	24 hours after operation	Amount of tramadol (milligram)

Trial Locations

Locations (1)

Eskisehir Osmangazi University; 🇹🇷 Eskişehir, Turkey